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    Clinical Trial Results:
    A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients with Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion

    Summary
    EudraCT number
    2020-000441-13
    Trial protocol
    DE   PT   AT   CZ   HU   FR   PL   IT  
    Global end of trial date
    12 Jul 2023

    Results information
    Results version number
    v1(current)
    This version publication date
    26 Jul 2024
    First version publication date
    26 Jul 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GR41986
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT04740931
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche, Ltd.
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, 4058
    Public contact
    F. Hoffmann-La Roche, Ltd., F. Hoffmann-La Roche, Ltd., +41 616878333, global.trial_information@roche.com
    Scientific contact
    F. Hoffmann-La Roche, Ltd., F. Hoffmann-La Roche, Ltd., +41 616878333, global.trial_information@roche.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Jul 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Jul 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary efficacy objective for this study is to evaluate the efficacy of faricimab 6 mg IVT Q4W compared with aflibercept 2 mg IVT Q4W on the basis of the change from baseline in BCVA at Week 24.
    Protection of trial subjects
    This study was conducted in full conformance with the ICH E6 guideline for Good Clinical Practice and the principles of the Declaration of Helsinki, or the laws and regulations of the country in which the research was conducted, whichever afforded the greater protection to the individual. All participants were required to read and sign an informed consent form prior to participation in the study.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    02 Mar 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 85
    Country: Number of subjects enrolled
    Australia: 25
    Country: Number of subjects enrolled
    Austria: 5
    Country: Number of subjects enrolled
    Brazil: 20
    Country: Number of subjects enrolled
    China: 57
    Country: Number of subjects enrolled
    Czechia: 7
    Country: Number of subjects enrolled
    France: 9
    Country: Number of subjects enrolled
    Germany: 9
    Country: Number of subjects enrolled
    Hong Kong: 4
    Country: Number of subjects enrolled
    Hungary: 15
    Country: Number of subjects enrolled
    Israel: 19
    Country: Number of subjects enrolled
    Italy: 4
    Country: Number of subjects enrolled
    Japan: 49
    Country: Number of subjects enrolled
    Korea, Republic of: 42
    Country: Number of subjects enrolled
    Poland: 84
    Country: Number of subjects enrolled
    Portugal: 9
    Country: Number of subjects enrolled
    Russian Federation: 25
    Country: Number of subjects enrolled
    Singapore: 3
    Country: Number of subjects enrolled
    Spain: 22
    Country: Number of subjects enrolled
    Taiwan: 12
    Country: Number of subjects enrolled
    United Kingdom: 36
    Country: Number of subjects enrolled
    United States: 188
    Worldwide total number of subjects
    729
    EEA total number of subjects
    164
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    320
    From 65 to 84 years
    377
    85 years and over
    32

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 1004 patients were screened; 14 of these patients were rescreened and randomized in the study. A total of 274 patients failed screening due to not meeting the inclusion criteria. A total of 729 patients with C/HRVO were randomized 1:1 into the study: 366 to the faricimab Q4W arm and 363 to the aflibercept Q4W arm.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)
    Arm description
    In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is administered (according to the PTI dosing regimen).
    Arm type
    Experimental

    Investigational medicinal product name
    Faricimab
    Investigational medicinal product code
    RO6867461
    Other name
    VABYSMO®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Patients randomly assigned to Arm A received 6 mg faricimab intravitreal injections once every 4 weeks (Q4W) from Day 1 through Week 20 (6 injections) in Part 1 of the study. In Part 2 of the study, patients in Arm A switched from faricimab Q4W to receive 6 mg faricimab intravitreal injections according to a personalized treatment interval (PTI) dosing regimen from Week 24 through Week 68.

    Arm title
    Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)
    Arm description
    In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is administered (according to the PTI dosing regimen).
    Arm type
    Active comparator

    Investigational medicinal product name
    Faricimab
    Investigational medicinal product code
    RO6867461
    Other name
    VABYSMO®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    In Part 2 of the study, patients in Arm B switched from aflibercept to receive 6 mg faricimab intravitreal injections according to a personalized treatment interval (PTI) dosing regimen from Week 24 through Week 68.

    Investigational medicinal product name
    Aflibercept
    Investigational medicinal product code
    Other name
    Eylea
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Patients randomly assigned to Arm B received 2 mg aflibercept intravitreal injections once every 4 weeks (Q4W) from Day 1 through Week 20 (6 injections) in Part 1 of the study.

    Number of subjects in period 1
    Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2) Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)
    Started
    366
    363
    Received ≥1 Dose of Study Drug (Part 1)
    365
    361
    Completed Part 1
    360
    353
    Started Part 2
    360
    353
    Completed
    333
    323
    Not completed
    33
    40
         Adverse event, serious fatal
    5
    3
         Consent withdrawn by subject
    11
    15
         Physician decision
    2
    2
         Adverse event, non-fatal
    6
    6
         Reason Not Specified
    3
    3
         Non-compliance with study drug
    3
    -
         Lost to follow-up
    3
    10
         Protocol deviation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)
    Reporting group description
    In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is administered (according to the PTI dosing regimen).

    Reporting group title
    Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)
    Reporting group description
    In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is administered (according to the PTI dosing regimen).

    Reporting group values
    Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2) Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2) Total
    Number of subjects
    366 363 729
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    162 158 320
        From 65-84 years
    184 193 377
        85 years and over
    20 12 32
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    65.6 ( 13.1 ) 64.7 ( 13.3 ) -
    Sex: Female, Male
    Units: Participants
        Female
    173 163 336
        Male
    193 200 393
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    2 3 5
        Asian
    89 88 177
        Native Hawaiian or Other Pacific Islander
    0 1 1
        Black or African American
    10 13 23
        White
    243 253 496
        More than one race
    1 0 1
        Unknown or Not Reported
    21 5 26
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    66 73 139
        Not Hispanic or Latino
    286 283 569
        Unknown or Not Reported
    14 7 21
    Region of Enrollment
    Units: Subjects
        Rest of World
    187 187 374
        USA and Canada
    95 93 188
        Asia
    84 83 167
    Number of Participants by the Eye (Left or Right) Chosen as the Study Eye
    Units: Subjects
        Left Eye
    180 181 361
        Right Eye
    186 182 368
    Number of Participants by the BCVA Letter Score Categories in the Study Eye
    Units: Subjects
        ≤34 Letters (20/200 or Worse)
    79 80 159
        >34 Letters to <55 Letters
    106 105 211
        ≥55 Letters (20/80 or Better)
    181 178 359
    Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye
    Units: ETDRS Letters
        arithmetic mean (standard deviation)
    50.25 ( 16.25 ) 50.71 ( 16.34 ) -
    Subject analysis sets

    Subject analysis set title
    Arm A: Faricimab Q4W (Part 1)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).

    Subject analysis set title
    Arm B: Aflibercept Q4W (Part 1)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).

    Subject analysis set title
    Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).

    Subject analysis set title
    Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).

    Subject analysis set title
    Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).

    Subject analysis set title
    Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).

    Subject analysis set title
    Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).

    Subject analysis set title
    Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).

    Subject analysis set title
    Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).

    Subject analysis set title
    Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).

    Subject analysis set title
    Arm A: Faricimab Q4W (Part 1)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).

    Subject analysis set title
    Arm B: Aflibercept Q4W (Part 1)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).

    Subject analysis set title
    All Faricimab Participants
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    This immunogenicity analysis group represents all participants with an evaluable ADA sample. At baseline, evaluable participants were those with an ADA sample prior to faricimab injection, including those who did not receive study treatment; post-baseline, evaluable participants were those with an ADA sample after having received at least one dose of faricimab.

    Subject analysis sets values
    Arm A: Faricimab Q4W (Part 1) Arm B: Aflibercept Q4W (Part 1) Arm A: Faricimab Q4W to Faricimab PTI (Part 2) Arm B: Aflibercept Q4W to Faricimab PTI (Part 2) Arm A: Faricimab Q4W to Faricimab PTI (Part 2) Arm B: Aflibercept Q4W to Faricimab PTI (Part 2) Arm A: Faricimab Q4W to Faricimab PTI (Part 2) Arm B: Aflibercept Q4W to Faricimab PTI (Part 2) Arm A: Faricimab Q4W to Faricimab PTI (Part 2) Arm B: Aflibercept Q4W to Faricimab PTI (Part 2) Arm A: Faricimab Q4W (Part 1) Arm B: Aflibercept Q4W (Part 1) All Faricimab Participants
    Number of subjects
    366
    363
    340
    331
    366
    363
    330
    315
    359
    342
    365
    361
    708
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    16.9 ( )
    17.3 ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    5.0 ( )
    4.0 ( )
    ( )
    ( )
    ( )
    Sex: Female, Male
    Units: Participants
        Female
        Male
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
        Asian
        Native Hawaiian or Other Pacific Islander
        Black or African American
        White
        More than one race
        Unknown or Not Reported
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
        Not Hispanic or Latino
        Unknown or Not Reported
    Region of Enrollment
    Units: Subjects
        Rest of World
        USA and Canada
        Asia
    Number of Participants by the Eye (Left or Right) Chosen as the Study Eye
    Units: Subjects
        Left Eye
        Right Eye
    Number of Participants by the BCVA Letter Score Categories in the Study Eye
    Units: Subjects
        ≤34 Letters (20/200 or Worse)
        >34 Letters to <55 Letters
        ≥55 Letters (20/80 or Better)
    Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye
    Units: ETDRS Letters
        arithmetic mean (standard deviation)
    16.9 ( )
    17.3 ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    5.0 ( )
    4.0 ( )
    ( )
    ( )
    ( )

    End points

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    End points reporting groups
    Reporting group title
    Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)
    Reporting group description
    In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is administered (according to the PTI dosing regimen).

    Reporting group title
    Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)
    Reporting group description
    In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is administered (according to the PTI dosing regimen).

    Subject analysis set title
    Arm A: Faricimab Q4W (Part 1)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).

    Subject analysis set title
    Arm B: Aflibercept Q4W (Part 1)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).

    Subject analysis set title
    Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).

    Subject analysis set title
    Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).

    Subject analysis set title
    Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).

    Subject analysis set title
    Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).

    Subject analysis set title
    Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).

    Subject analysis set title
    Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).

    Subject analysis set title
    Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).

    Subject analysis set title
    Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).

    Subject analysis set title
    Arm A: Faricimab Q4W (Part 1)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).

    Subject analysis set title
    Arm B: Aflibercept Q4W (Part 1)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).

    Subject analysis set title
    All Faricimab Participants
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    This immunogenicity analysis group represents all participants with an evaluable ADA sample. At baseline, evaluable participants were those with an ADA sample prior to faricimab injection, including those who did not receive study treatment; post-baseline, evaluable participants were those with an ADA sample after having received at least one dose of faricimab.

    Primary: Part 1: Change from Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 24

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    End point title
    Part 1: Change from Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 24
    End point description
    Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The Mixed Model of Repeated Measures (MMRM) analysis included the categorical covariates of treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), and randomization stratification factors [baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)] as fixed effects. An unstructured covariance structure was used. Missing data were implicitly imputed by MMRM model assuming missing at random. Treatment policy strategy (i.e., all observed values used) was applied to all intercurrent events (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). 95% CI is a rounding of 95.03% CI.
    End point type
    Primary
    End point timeframe
    From Baseline through Week 24
    End point values
    Arm A: Faricimab Q4W (Part 1) Arm B: Aflibercept Q4W (Part 1)
    Number of subjects analysed
    366
    363
    Units: ETDRS Letters
        arithmetic mean (confidence interval 95%)
    16.9 (15.4 to 18.3)
    17.3 (15.9 to 18.8)
    Statistical analysis title
    BCVA Superiority
    Statistical analysis description
    The final sample size provided >80% power for a 3.5-letter superiority assessment of faricimab over aflibercept (at a two-sided 0.0497 significance level).
    Comparison groups
    Arm A: Faricimab Q4W (Part 1) v Arm B: Aflibercept Q4W (Part 1)
    Number of subjects included in analysis
    729
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.6715 [1]
    Method
    Mixed Model of Repeated Measures
    Parameter type
    Difference in Adjusted Means
    Point estimate
    -0.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.5
         upper limit
    1.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.04
    Notes
    [1] - Tested at a two-sided p<0.0497 significance level.
    Statistical analysis title
    BCVA Non-inferiority
    Statistical analysis description
    The null hypothesis, H0: μ(faricimab) − μ(aflibercept) ≤−4 letters; the alternative hypothesis, Ha: μ(faricimab) − μ(aflibercept) >−4 letters. The final sample size provided >90% power for the non-inferiority assessment (at a one-sided 0.02485 significance level).
    Comparison groups
    Arm A: Faricimab Q4W (Part 1) v Arm B: Aflibercept Q4W (Part 1)
    Number of subjects included in analysis
    729
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [2]
    Method
    Parameter type
    Difference in Adjusted Means
    Point estimate
    -0.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.5
         upper limit
    1.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.04
    Notes
    [2] - If the lower bound of a two-sided 95% confidence interval (CI) for the difference in adjusted means of the two treatments (faricimab minus aflibercept) is greater than -4 letters (the non-inferiority margin), then faricimab is considered non-inferior to aflibercept.

    Secondary: Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline in the Study Eye at Week 24

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    End point title
    Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline in the Study Eye at Week 24
    End point description
    Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
    End point type
    Secondary
    End point timeframe
    From Baseline through Week 24
    End point values
    Arm A: Faricimab Q4W (Part 1) Arm B: Aflibercept Q4W (Part 1)
    Number of subjects analysed
    366
    363
    Units: Percentage of participants
        number (confidence interval 95%)
    56.6 (51.7 to 61.5)
    58.1 (53.3 to 62.9)
    Statistical analysis title
    Gaining ≥15 Letters
    Comparison groups
    Arm A: Faricimab Q4W (Part 1) v Arm B: Aflibercept Q4W (Part 1)
    Number of subjects included in analysis
    729
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Difference in CMH Weighted Percentage
    Point estimate
    -1.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -8.4
         upper limit
    5.3

    Secondary: Part 1: Change from Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 24

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    End point title
    Part 1: Change from Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 24
    End point description
    Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The Mixed Model of Repeated Measures (MMRM) analysis included the categorical covariates of treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), and randomization stratification factors [baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)] as fixed effects. An unstructured covariance structure was used. Missing data were implicitly imputed by MMRM model assuming missing at random. Treatment policy strategy (i.e., all observed values used) was applied to all intercurrent events (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). 95% CI is a rounding of 95.03% CI.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, and 24
    End point values
    Arm A: Faricimab Q4W (Part 1) Arm B: Aflibercept Q4W (Part 1)
    Number of subjects analysed
    366
    363
    Units: ETDRS Letters
    arithmetic mean (confidence interval 95%)
        Week 4
    13.5 (12.5 to 14.6)
    14.3 (13.2 to 15.4)
        Week 8
    15.5 (14.4 to 16.7)
    16.5 (15.3 to 17.7)
        Week 12
    16.9 (15.7 to 18.2)
    17.1 (15.8 to 18.4)
        Week 16
    16.8 (15.4 to 18.1)
    17.5 (16.2 to 18.9)
        Week 20
    17.0 (15.6 to 18.3)
    17.2 (15.8 to 18.5)
        Week 24
    16.9 (15.4 to 18.3)
    17.3 (15.9 to 18.8)
    No statistical analyses for this end point

    Secondary: Part 1: Percentage of Participants Gaining ≥10 Letters in BCVA from Baseline in the Study Eye at Specified Timepoints Through Week 24

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    End point title
    Part 1: Percentage of Participants Gaining ≥10 Letters in BCVA from Baseline in the Study Eye at Specified Timepoints Through Week 24
    End point description
    Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, and 24
    End point values
    Arm A: Faricimab Q4W (Part 1) Arm B: Aflibercept Q4W (Part 1)
    Number of subjects analysed
    366
    363
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 4
    60.9 (56.0 to 65.8)
    62.3 (57.6 to 66.9)
        Week 8
    69.1 (64.5 to 73.7)
    72.8 (68.3 to 77.2)
        Week 12
    73.2 (68.8 to 77.7)
    74.7 (70.3 to 79.0)
        Week 16
    73.5 (69.1 to 78.0)
    75.8 (71.4 to 80.1)
        Week 20
    72.4 (68.0 to 76.9)
    74.1 (69.7 to 78.5)
        Week 24
    72.2 (67.7 to 76.6)
    73.3 (68.8 to 77.7)
    No statistical analyses for this end point

    Secondary: Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline in the Study Eye at Specified Timepoints Through Week 24

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    End point title
    Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline in the Study Eye at Specified Timepoints Through Week 24
    End point description
    Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, and 24
    End point values
    Arm A: Faricimab Q4W (Part 1) Arm B: Aflibercept Q4W (Part 1)
    Number of subjects analysed
    366
    363
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 4
    41.5 (36.7 to 46.3)
    45.4 (40.7 to 50.2)
        Week 8
    51.1 (46.3 to 55.9)
    53.7 (48.9 to 58.5)
        Week 12
    54.6 (49.8 to 59.4)
    55.1 (50.3 to 59.9)
        Week 16
    57.7 (52.8 to 62.5)
    59.5 (54.7 to 64.3)
        Week 20
    56.6 (51.7 to 61.4)
    57.8 (53.0 to 62.6)
        Week 24
    56.6 (51.7 to 61.5)
    58.1 (53.3 to 62.9)
    No statistical analyses for this end point

    Secondary: Part 1: Percentage of Participants Gaining ≥5 Letters in BCVA from Baseline in the Study Eye at Specified Timepoints Through Week 24

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    End point title
    Part 1: Percentage of Participants Gaining ≥5 Letters in BCVA from Baseline in the Study Eye at Specified Timepoints Through Week 24
    End point description
    Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, and 24
    End point values
    Arm A: Faricimab Q4W (Part 1) Arm B: Aflibercept Q4W (Part 1)
    Number of subjects analysed
    366
    363
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 4
    83.1 (79.3 to 86.9)
    83.5 (79.7 to 87.2)
        Week 8
    85.2 (81.7 to 88.8)
    86.8 (83.3 to 90.2)
        Week 12
    87.4 (84.1 to 90.8)
    87.1 (83.7 to 90.5)
        Week 16
    86.3 (82.9 to 89.8)
    88.7 (85.5 to 92.0)
        Week 20
    84.1 (80.5 to 87.8)
    86.5 (83.0 to 90.0)
        Week 24
    85.3 (81.8 to 88.8)
    84.6 (80.9 to 88.2)
    No statistical analyses for this end point

    Secondary: Part 1: Percentage of Participants Gaining >0 Letters in BCVA from Baseline in the Study Eye at Specified Timepoints Through Week 24

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    End point title
    Part 1: Percentage of Participants Gaining >0 Letters in BCVA from Baseline in the Study Eye at Specified Timepoints Through Week 24
    End point description
    Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, and 24
    End point values
    Arm A: Faricimab Q4W (Part 1) Arm B: Aflibercept Q4W (Part 1)
    Number of subjects analysed
    366
    363
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 4
    92.1 (89.4 to 94.8)
    95.6 (93.5 to 97.7)
        Week 8
    92.1 (89.4 to 94.8)
    94.8 (92.5 to 97.0)
        Week 12
    93.2 (90.6 to 95.7)
    92.6 (89.9 to 95.2)
        Week 16
    92.6 (90.0 to 95.3)
    92.0 (89.3 to 94.8)
        Week 20
    90.5 (87.5 to 93.4)
    91.4 (88.6 to 94.3)
        Week 24
    90.5 (87.5 to 93.4)
    89.2 (86.1 to 92.4)
    No statistical analyses for this end point

    Secondary: Part 1: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Baseline in the Study Eye at Specified Timepoints Through Week 24

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    End point title
    Part 1: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Baseline in the Study Eye at Specified Timepoints Through Week 24
    End point description
    Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, and 24
    End point values
    Arm A: Faricimab Q4W (Part 1) Arm B: Aflibercept Q4W (Part 1)
    Number of subjects analysed
    366
    363
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 4
    98.4 (97.1 to 99.7)
    98.9 (97.8 to 100.0)
        Week 8
    98.1 (96.7 to 99.5)
    98.1 (96.7 to 99.5)
        Week 12
    98.6 (97.5 to 99.8)
    97.5 (95.9 to 99.1)
        Week 16
    97.3 (95.6 to 98.9)
    97.0 (95.2 to 98.7)
        Week 20
    97.0 (95.3 to 98.7)
    96.7 (94.9 to 98.5)
        Week 24
    96.2 (94.3 to 98.1)
    96.7 (94.9 to 98.5)
    No statistical analyses for this end point

    Secondary: Part 1: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA from Baseline in the Study Eye at Specified Timepoints Through Week 24

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    End point title
    Part 1: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA from Baseline in the Study Eye at Specified Timepoints Through Week 24
    End point description
    Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, and 24
    End point values
    Arm A: Faricimab Q4W (Part 1) Arm B: Aflibercept Q4W (Part 1)
    Number of subjects analysed
    366
    363
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 4
    98.1 (96.7 to 99.5)
    98.6 (97.4 to 99.8)
        Week 8
    97.5 (96.0 to 99.1)
    97.5 (95.9 to 99.1)
        Week 12
    97.8 (96.3 to 99.3)
    97.0 (95.2 to 98.7)
        Week 16
    95.9 (93.9 to 97.9)
    96.1 (94.2 to 98.1)
        Week 20
    96.7 (94.9 to 98.5)
    96.1 (94.2 to 98.1)
        Week 24
    95.1 (92.9 to 97.3)
    95.9 (93.8 to 97.9)
    No statistical analyses for this end point

    Secondary: Part 1: Percentage of Participants Achieving ≥84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24

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    End point title
    Part 1: Percentage of Participants Achieving ≥84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24
    End point description
    Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, and 24
    End point values
    Arm A: Faricimab Q4W (Part 1) Arm B: Aflibercept Q4W (Part 1)
    Number of subjects analysed
    366
    363
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 4
    6.0 (3.6 to 8.4)
    4.7 (2.6 to 6.8)
        Week 8
    8.7 (5.9 to 11.5)
    10.2 (7.2 to 13.2)
        Week 12
    10.9 (7.8 to 14.0)
    11.9 (8.7 to 15.0)
        Week 16
    11.5 (8.4 to 14.6)
    14.1 (10.7 to 17.5)
        Week 20
    14.2 (10.9 to 17.6)
    14.9 (11.4 to 18.3)
        Week 24
    14.5 (11.0 to 17.9)
    15.2 (11.7 to 18.7)
    No statistical analyses for this end point

    Secondary: Part 1: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA from Baseline in the Study Eye at Specified Timepoints Through Week 24

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    End point title
    Part 1: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA from Baseline in the Study Eye at Specified Timepoints Through Week 24
    End point description
    Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, and 24
    End point values
    Arm A: Faricimab Q4W (Part 1) Arm B: Aflibercept Q4W (Part 1)
    Number of subjects analysed
    366
    363
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 4
    97.0 (95.3 to 98.7)
    98.1 (96.7 to 99.5)
        Week 8
    96.2 (94.2 to 98.1)
    96.4 (94.5 to 98.3)
        Week 12
    95.9 (93.9 to 97.9)
    96.1 (94.2 to 98.1)
        Week 16
    95.4 (93.2 to 97.5)
    94.8 (92.5 to 97.0)
        Week 20
    94.8 (92.6 to 97.1)
    93.9 (91.5 to 96.4)
        Week 24
    94.0 (91.6 to 96.4)
    93.7 (91.2 to 96.1)
    No statistical analyses for this end point

    Secondary: Part 1: Percentage of Participants Achieving ≥69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24

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    End point title
    Part 1: Percentage of Participants Achieving ≥69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24
    End point description
    Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, and 24
    End point values
    Arm A: Faricimab Q4W (Part 1) Arm B: Aflibercept Q4W (Part 1)
    Number of subjects analysed
    366
    363
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 4
    45.0 (41.0 to 49.1)
    46.1 (41.9 to 50.2)
        Week 8
    48.6 (44.3 to 52.8)
    54.6 (50.5 to 58.7)
        Week 12
    54.9 (50.8 to 58.9)
    55.7 (51.4 to 60.0)
        Week 16
    54.9 (50.6 to 59.1)
    59.3 (55.2 to 63.4)
        Week 20
    54.1 (49.7 to 58.4)
    57.6 (53.4 to 61.8)
        Week 24
    55.7 (51.3 to 60.0)
    59.0 (54.5 to 63.4)
    No statistical analyses for this end point

    Secondary: Part 1: Percentage of Participants with ≤38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24

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    End point title
    Part 1: Percentage of Participants with ≤38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24
    End point description
    Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (>38 and ≤38 letters) and region (U.S. and Canada, Asia, and rest of the world). All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, and 24
    End point values
    Arm A: Faricimab Q4W (Part 1) Arm B: Aflibercept Q4W (Part 1)
    Number of subjects analysed
    366
    363
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 4
    10.0 (7.3 to 12.8)
    8.6 (6.1 to 11.1)
        Week 8
    8.2 (5.5 to 10.8)
    7.0 (4.6 to 9.4)
        Week 12
    7.3 (4.9 to 9.8)
    6.4 (4.0 to 8.8)
        Week 16
    7.8 (5.3 to 10.4)
    6.2 (3.8 to 8.5)
        Week 20
    8.4 (5.7 to 11.0)
    6.4 (4.0 to 8.8)
        Week 24
    10.1 (7.1 to 13.0)
    7.5 (4.9 to 10.1)
    No statistical analyses for this end point

    Secondary: Part 1: Percentage of Participants with Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 24

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    End point title
    Part 1: Percentage of Participants with Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 24
    End point description
    Absence of diabetic macular edema was defined as achieving a central subfield thickness of <325 microns in the study eye. Central subfield thickness was defined as the distance between the internal limiting membrane (ILM) and Bruch's membrane (BM) as assessed by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, and 24
    End point values
    Arm A: Faricimab Q4W (Part 1) Arm B: Aflibercept Q4W (Part 1)
    Number of subjects analysed
    366
    363
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 4
    83.8 (80.2 to 87.5)
    82.4 (78.5 to 86.2)
        Week 8
    92.6 (90.0 to 95.2)
    91.2 (88.3 to 94.1)
        Week 12
    93.4 (90.9 to 95.9)
    91.5 (88.6 to 94.3)
        Week 16
    94.5 (92.2 to 96.8)
    92.8 (90.2 to 95.5)
        Week 20
    94.8 (92.6 to 97.1)
    93.1 (90.5 to 95.7)
        Week 24
    93.7 (91.2 to 96.2)
    92.0 (89.2 to 94.7)
    No statistical analyses for this end point

    Secondary: Part 1: Change from Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 24

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    End point title
    Part 1: Change from Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 24
    End point description
    Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and the Bruch's membrane (BM) using optical coherence tomography (OCT), as assessed by the central reading center. The Mixed Model of Repeated Measures (MMRM) analysis included the categorical covariates of treatment arm, visit, visit-by-treatment arm interaction, baseline CST (continuous), and randomization stratification factors [baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)] as fixed effects. An unstructured covariance structure was used. Missing data were implicitly imputed by MMRM model assuming missing at random. Treatment policy strategy (i.e., all observed values used) was applied to all intercurrent events (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). 95% CI is a rounding of 95.03% CI.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, and 24
    End point values
    Arm A: Faricimab Q4W (Part 1) Arm B: Aflibercept Q4W (Part 1)
    Number of subjects analysed
    366
    363
    Units: microns
    arithmetic mean (confidence interval 95%)
        Week 4
    -420.8 (-429.2 to -412.5)
    -417.3 (-425.6 to -409.0)
        Week 8
    -444.2 (-452.7 to -435.7)
    -437.5 (-446.1 to -429.0)
        Week 12
    -451.0 (-460.6 to -441.5)
    -442.5 (-452.1 to -433.0)
        Week 16
    -452.5 (-461.8 to -443.1)
    -445.2 (-454.7 to -435.8)
        Week 20
    -459.4 (-467.8 to -451.0)
    -445.1 (-453.6 to -436.6)
        Week 24
    -461.6 (-471.4 to -451.9)
    -448.8 (-458.6 to -439.0)
    No statistical analyses for this end point

    Secondary: Part 1: Percentage of Participants with Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 24

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    End point title
    Part 1: Percentage of Participants with Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
    End point description
    Intraretinal fluid was measured in the study eye using optical coherence tomography (OCT) in the central subfield (center 1 mm) by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, and 24
    End point values
    Arm A: Faricimab Q4W (Part 1) Arm B: Aflibercept Q4W (Part 1)
    Number of subjects analysed
    366
    363
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 4
    45.5 (40.6 to 50.5)
    40.3 (35.6 to 45.0)
        Week 8
    63.1 (58.3 to 68.0)
    61.7 (56.9 to 66.6)
        Week 12
    53.2 (48.3 to 58.2)
    51.0 (46.2 to 55.9)
        Week 16
    55.4 (50.5 to 60.3)
    51.9 (46.8 to 56.9)
        Week 20
    59.0 (54.0 to 63.9)
    56.5 (51.6 to 61.5)
        Week 24
    76.2 (71.9 to 80.5)
    70.8 (66.2 to 75.4)
    No statistical analyses for this end point

    Secondary: Part 1: Percentage of Participants with Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24

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    End point title
    Part 1: Percentage of Participants with Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
    End point description
    Subretinal fluid was measured in the study eye using optical coherence tomography (OCT) in the central subfield (center 1 mm) by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, and 24
    End point values
    Arm A: Faricimab Q4W (Part 1) Arm B: Aflibercept Q4W (Part 1)
    Number of subjects analysed
    366
    363
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 4
    66.1 (61.4 to 70.8)
    65.0 (60.3 to 69.7)
        Week 8
    89.6 (86.5 to 92.6)
    90.1 (87.0 to 93.1)
        Week 12
    94.0 (91.6 to 96.4)
    93.9 (91.5 to 96.4)
        Week 16
    95.3 (93.2 to 97.5)
    95.6 (93.5 to 97.7)
        Week 20
    95.9 (93.9 to 97.9)
    94.5 (92.2 to 96.8)
        Week 24
    96.4 (94.6 to 98.3)
    93.4 (90.8 to 95.9)
    No statistical analyses for this end point

    Secondary: Part 1: Percentage of Participants with Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24

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    End point title
    Part 1: Percentage of Participants with Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
    End point description
    Intraretinal fluid and subretinal fluid were measured in the study eye using optical coherence tomography (OCT) in the central subfield (center 1 mm) by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, and 24
    End point values
    Arm A: Faricimab Q4W (Part 1) Arm B: Aflibercept Q4W (Part 1)
    Number of subjects analysed
    366
    363
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 4
    33.0 (28.3 to 37.6)
    29.3 (24.9 to 33.7)
        Week 8
    59.3 (54.4 to 64.1)
    59.3 (54.3 to 64.2)
        Week 12
    52.7 (47.7 to 57.6)
    50.2 (45.3 to 55.1)
        Week 16
    54.9 (49.9 to 59.8)
    51.3 (46.3 to 56.3)
        Week 20
    58.2 (53.2 to 63.1)
    55.4 (50.5 to 60.4)
        Week 24
    75.1 (70.8 to 79.5)
    68.6 (63.8 to 73.4)
    No statistical analyses for this end point

    Secondary: Part 1: Change from Baseline in National Eye Institute 25-Item Visual Functioning Questionnaire (NEI VFQ-25) Composite Score at Week 24

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    End point title
    Part 1: Change from Baseline in National Eye Institute 25-Item Visual Functioning Questionnaire (NEI VFQ-25) Composite Score at Week 24
    End point description
    The NEI VFQ-25 captures a patient’s perception of vision-related functioning and vision-related quality of life. The core measure includes 25 items that comprise 11 vision-related subscales and 1 item on general health. The composite score ranges from 0 to 100, with higher scores indicating better vision-related functioning. For the ANCOVA analysis, the model uses the non-missing change from baseline in BCVA at Weeks 24 as the response variables adjusted for the treatment group, baseline NEI VFQ-25 Composite Score (continuous), baseline BCVA score (≥55 and ≤54 letters) and region (U.S. and Canada, Asia, and the rest of the world). Observed NEI VFQ-25 assessments were used regardless of the occurrence of intercurrent events. Missing data were not imputed. 95% CI is a rounding of 95.03% CI.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    End point values
    Arm A: Faricimab Q4W (Part 1) Arm B: Aflibercept Q4W (Part 1)
    Number of subjects analysed
    339
    330
    Units: score on a scale
        arithmetic mean (confidence interval 95%)
    6.9 (5.8 to 8.0)
    8.1 (7.0 to 9.2)
    Statistical analysis title
    NEI VFQ-25 at Week 24
    Comparison groups
    Arm A: Faricimab Q4W (Part 1) v Arm B: Aflibercept Q4W (Part 1)
    Number of subjects included in analysis
    669
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Difference in Adjusted Means
    Point estimate
    -1.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.7
         upper limit
    0.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.77

    Secondary: Parts 1 and 2: Change from Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72

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    End point title
    Parts 1 and 2: Change from Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72
    End point description
    Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The Mixed Model of Repeated Measures (MMRM) analysis included the categorical covariates of treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), and randomization stratification factors [baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)] as fixed effects. An unstructured covariance structure was used. Missing data were implicitly imputed by MMRM model assuming missing at random. Treatment policy strategy (i.e., all observed values used) was applied to all intercurrent events (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). 95% CI is a rounding of 95.03% CI.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
    End point values
    Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2) Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)
    Number of subjects analysed
    366
    363
    Units: ETDRS Letters
    arithmetic mean (confidence interval 95%)
        Week 4
    13.6 (12.5 to 14.6)
    14.3 (13.3 to 15.4)
        Week 8
    15.6 (14.4 to 16.8)
    16.5 (15.4 to 17.7)
        Week 12
    17.0 (15.7 to 18.2)
    17.2 (15.9 to 18.4)
        Week 16
    16.8 (15.5 to 18.1)
    17.6 (16.2 to 18.9)
        Week 20
    17.0 (15.7 to 18.4)
    17.3 (15.9 to 18.6)
        Week 24
    16.9 (15.5 to 18.3)
    17.3 (15.9 to 18.8)
        Week 28
    16.0 (14.5 to 17.5)
    16.0 (14.4 to 17.5)
        Week 32
    17.2 (15.7 to 18.7)
    17.5 (16.0 to 19.0)
        Week 36
    17.0 (15.5 to 18.5)
    17.5 (15.9 to 19.0)
        Week 40
    15.8 (14.2 to 17.5)
    16.2 (14.5 to 17.9)
        Week 44
    16.5 (14.9 to 18.2)
    17.3 (15.7 to 19.0)
        Week 48
    16.9 (15.2 to 18.5)
    17.6 (15.9 to 19.3)
        Week 52
    16.4 (14.8 to 18.1)
    17.8 (16.2 to 19.5)
        Week 56
    16.0 (14.3 to 17.7)
    16.9 (15.2 to 18.6)
        Week 60
    16.9 (15.2 to 18.6)
    17.3 (15.6 to 19.0)
        Week 64
    16.8 (15.1 to 18.5)
    17.2 (15.5 to 18.9)
        Week 68
    16.9 (15.2 to 18.7)
    17.0 (15.2 to 18.7)
        Week 72
    16.9 (15.1 to 18.6)
    17.1 (15.3 to 18.8)
    No statistical analyses for this end point

    Secondary: Parts 1 and 2: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline in the Study Eye at Specified Timepoints Through Week 72

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    End point title
    Parts 1 and 2: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline in the Study Eye at Specified Timepoints Through Week 72
    End point description
    Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
    End point values
    Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2) Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)
    Number of subjects analysed
    366
    363
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 4
    41.5 (36.7 to 46.3)
    45.2 (40.4 to 49.9)
        Week 8
    51.1 (46.3 to 55.9)
    53.7 (48.9 to 58.5)
        Week 12
    54.6 (49.8 to 59.4)
    55.1 (50.3 to 59.9)
        Week 16
    57.7 (52.8 to 62.5)
    59.5 (54.7 to 64.3)
        Week 20
    56.6 (51.7 to 61.4)
    57.8 (53.0 to 62.6)
        Week 24
    56.6 (51.7 to 61.5)
    58.1 (53.3 to 62.9)
        Week 28
    53.3 (48.4 to 58.2)
    54.8 (50.0 to 59.6)
        Week 32
    60.9 (56.1 to 65.8)
    57.6 (52.7 to 62.4)
        Week 36
    58.2 (53.3 to 63.1)
    58.9 (54.2 to 63.7)
        Week 40
    56.6 (51.7 to 61.4)
    55.9 (51.1 to 60.7)
        Week 44
    55.7 (50.9 to 60.6)
    57.3 (52.5 to 62.1)
        Week 48
    58.8 (53.9 to 63.6)
    58.1 (53.3 to 62.9)
        Week 52
    57.6 (52.7 to 62.5)
    58.7 (53.8 to 63.5)
        Week 56
    56.3 (51.3 to 61.2)
    57.3 (52.5 to 62.2)
        Week 60
    58.2 (53.3 to 63.1)
    59.0 (54.1 to 63.8)
        Week 64
    57.1 (52.3 to 61.9)
    59.5 (54.7 to 64.3)
        Week 68
    56.8 (52.0 to 61.6)
    59.8 (54.9 to 64.6)
        Week 72
    58.7 (53.9 to 63.6)
    60.0 (55.2 to 64.9)
    No statistical analyses for this end point

    Secondary: Parts 1 and 2: Percentage of Participants Gaining ≥10 Letters in BCVA from Baseline in the Study Eye at Specified Timepoints Through Week 72

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    End point title
    Parts 1 and 2: Percentage of Participants Gaining ≥10 Letters in BCVA from Baseline in the Study Eye at Specified Timepoints Through Week 72
    End point description
    Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
    End point values
    Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2) Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)
    Number of subjects analysed
    366
    363
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 4
    60.9 (56.0 to 65.8)
    62.3 (57.6 to 66.9)
        Week 8
    69.1 (64.5 to 73.7)
    72.8 (68.3 to 77.2)
        Week 12
    73.2 (68.8 to 77.7)
    74.7 (70.3 to 79.0)
        Week 16
    73.5 (69.1 to 78.0)
    75.8 (71.4 to 80.1)
        Week 20
    72.4 (68.0 to 76.9)
    74.1 (69.7 to 78.5)
        Week 24
    72.2 (67.7 to 76.6)
    73.3 (68.8 to 77.7)
        Week 28
    69.7 (65.1 to 74.3)
    70.5 (66.0 to 75.1)
        Week 32
    73.0 (68.5 to 77.4)
    74.4 (70.0 to 78.8)
        Week 36
    73.8 (69.3 to 78.2)
    74.9 (70.6 to 79.3)
        Week 40
    71.0 (66.5 to 75.6)
    73.0 (68.6 to 77.5)
        Week 44
    71.6 (67.1 to 76.1)
    74.1 (69.7 to 78.5)
        Week 48
    71.9 (67.3 to 76.4)
    75.5 (71.1 to 79.9)
        Week 52
    71.0 (66.4 to 75.6)
    73.8 (69.4 to 78.3)
        Week 56
    70.8 (66.2 to 75.3)
    72.2 (67.6 to 76.7)
        Week 60
    72.7 (68.2 to 77.2)
    72.5 (67.9 to 77.0)
        Week 64
    72.4 (67.9 to 76.9)
    71.6 (67.0 to 76.2)
        Week 68
    72.1 (67.7 to 76.6)
    70.5 (65.9 to 75.1)
        Week 72
    71.6 (67.1 to 76.1)
    73.0 (68.5 to 77.5)
    No statistical analyses for this end point

    Secondary: Parts 1 and 2: Percentage of Participants Gaining ≥5 Letters in BCVA from Baseline in the Study Eye at Specified Timepoints Through Week 72

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    End point title
    Parts 1 and 2: Percentage of Participants Gaining ≥5 Letters in BCVA from Baseline in the Study Eye at Specified Timepoints Through Week 72
    End point description
    Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
    End point values
    Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2) Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)
    Number of subjects analysed
    366
    363
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 4
    83.1 (79.3 to 86.9)
    83.5 (79.7 to 87.2)
        Week 8
    85.2 (81.7 to 88.8)
    86.8 (83.3 to 90.2)
        Week 12
    87.4 (84.1 to 90.8)
    87.1 (83.7 to 90.5)
        Week 16
    86.3 (82.9 to 89.8)
    88.7 (85.5 to 92.0)
        Week 20
    84.1 (80.5 to 87.8)
    86.5 (83.0 to 90.0)
        Week 24
    85.3 (81.8 to 88.8)
    84.6 (80.9 to 88.2)
        Week 28
    81.7 (77.8 to 85.6)
    84.0 (80.3 to 87.7)
        Week 32
    84.2 (80.5 to 87.8)
    87.3 (83.9 to 90.7)
        Week 36
    84.7 (81.1 to 88.3)
    85.7 (82.1 to 89.3)
        Week 40
    82.3 (78.4 to 86.1)
    84.3 (80.6 to 88.0)
        Week 44
    82.8 (79.0 to 86.6)
    84.9 (81.2 to 88.5)
        Week 48
    83.6 (79.9 to 87.3)
    83.7 (80.0 to 87.5)
        Week 52
    80.9 (76.9 to 84.8)
    84.0 (80.3 to 87.8)
        Week 56
    79.2 (75.2 to 83.3)
    81.5 (77.6 to 85.5)
        Week 60
    82.8 (79.0 to 86.6)
    81.6 (77.6 to 85.5)
        Week 64
    80.6 (76.6 to 84.6)
    81.5 (77.6 to 85.5)
        Week 68
    83.3 (79.6 to 87.1)
    80.2 (76.1 to 84.2)
        Week 72
    83.6 (79.9 to 87.3)
    79.6 (75.5 to 83.7)
    No statistical analyses for this end point

    Secondary: Parts 1 and 2: Percentage of Participants Gaining >0 Letters in BCVA from Baseline in the Study Eye at Specified Timepoints Through Week 72

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    End point title
    Parts 1 and 2: Percentage of Participants Gaining >0 Letters in BCVA from Baseline in the Study Eye at Specified Timepoints Through Week 72
    End point description
    Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
    End point values
    Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2) Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)
    Number of subjects analysed
    366
    363
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 4
    92.1 (89.4 to 94.8)
    95.6 (93.5 to 97.7)
        Week 8
    92.1 (89.4 to 94.8)
    94.8 (92.5 to 97.0)
        Week 12
    93.2 (90.6 to 95.7)
    92.6 (89.9 to 95.2)
        Week 16
    92.6 (90.0 to 95.3)
    92.0 (89.3 to 94.8)
        Week 20
    90.5 (87.5 to 93.4)
    91.4 (88.6 to 94.3)
        Week 24
    90.5 (87.5 to 93.4)
    89.2 (86.1 to 92.4)
        Week 28
    88.0 (84.7 to 91.3)
    88.4 (85.2 to 91.7)
        Week 32
    89.4 (86.2 to 92.5)
    92.0 (89.2 to 94.8)
        Week 36
    89.9 (86.9 to 93.0)
    90.1 (87.0 to 93.1)
        Week 40
    87.7 (84.5 to 91.0)
    88.7 (85.5 to 91.9)
        Week 44
    88.5 (85.3 to 91.7)
    89.2 (86.1 to 92.4)
        Week 48
    88.5 (85.3 to 91.7)
    88.7 (85.5 to 91.9)
        Week 52
    85.8 (82.2 to 89.3)
    89.0 (85.8 to 92.2)
        Week 56
    85.8 (82.3 to 89.3)
    87.3 (83.9 to 90.7)
        Week 60
    86.6 (83.2 to 90.0)
    87.3 (83.9 to 90.7)
        Week 64
    86.1 (82.6 to 89.6)
    86.2 (82.7 to 89.7)
        Week 68
    87.4 (84.1 to 90.8)
    85.4 (81.8 to 89.0)
        Week 72
    86.6 (83.2 to 90.1)
    85.7 (82.1 to 89.2)
    No statistical analyses for this end point

    Secondary: Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Baseline in the Study Eye at Specified Timepoints Through Week 72

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    End point title
    Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Baseline in the Study Eye at Specified Timepoints Through Week 72
    End point description
    Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
    End point values
    Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2) Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)
    Number of subjects analysed
    366
    363
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 4
    98.4 (97.1 to 99.7)
    98.9 (97.8 to 100.0)
        Week 8
    98.1 (96.7 to 99.5)
    98.1 (96.7 to 99.5)
        Week 12
    98.6 (97.5 to 99.8)
    97.5 (95.9 to 99.1)
        Week 16
    97.3 (95.6 to 98.9)
    97.0 (95.2 to 98.7)
        Week 20
    97.0 (95.3 to 98.7)
    96.7 (94.9 to 98.5)
        Week 24
    96.2 (94.3 to 98.1)
    96.7 (94.9 to 98.5)
        Week 28
    95.6 (93.6 to 97.7)
    94.2 (91.8 to 96.6)
        Week 32
    95.4 (93.3 to 97.5)
    96.1 (94.2 to 98.1)
        Week 36
    95.4 (93.3 to 97.5)
    95.9 (93.8 to 97.9)
        Week 40
    94.0 (91.6 to 96.4)
    95.9 (93.8 to 97.9)
        Week 44
    94.0 (91.6 to 96.4)
    95.6 (93.5 to 97.7)
        Week 48
    94.0 (91.6 to 96.4)
    95.6 (93.5 to 97.7)
        Week 52
    94.6 (92.3 to 96.8)
    96.7 (94.9 to 98.5)
        Week 56
    95.1 (92.9 to 97.3)
    95.6 (93.5 to 97.7)
        Week 60
    93.5 (91.0 to 96.0)
    95.3 (93.2 to 97.5)
        Week 64
    94.0 (91.6 to 96.4)
    94.8 (92.5 to 97.0)
        Week 68
    93.5 (90.9 to 96.0)
    95.9 (93.8 to 97.9)
        Week 72
    93.2 (90.6 to 95.7)
    95.0 (92.8 to 97.2)
    No statistical analyses for this end point

    Secondary: Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA from Baseline in the Study Eye at Specified Timepoints Through Week 72

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    End point title
    Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA from Baseline in the Study Eye at Specified Timepoints Through Week 72
    End point description
    Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
    End point values
    Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2) Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)
    Number of subjects analysed
    366
    363
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 4
    98.1 (96.7 to 99.5)
    98.6 (97.4 to 99.8)
        Week 8
    97.5 (96.0 to 99.1)
    97.5 (95.9 to 99.1)
        Week 12
    97.8 (96.3 to 99.3)
    97.0 (95.2 to 98.7)
        Week 16
    95.9 (93.9 to 97.9)
    96.1 (94.2 to 98.1)
        Week 20
    96.7 (94.9 to 98.5)
    96.1 (94.2 to 98.1)
        Week 24
    95.1 (92.9 to 97.3)
    95.9 (93.8 to 97.9)
        Week 28
    94.6 (92.3 to 96.9)
    93.4 (90.9 to 95.9)
        Week 32
    94.3 (91.9 to 96.6)
    95.9 (93.8 to 97.9)
        Week 36
    94.3 (91.9 to 96.6)
    95.0 (92.8 to 97.3)
        Week 40
    92.9 (90.3 to 95.5)
    93.9 (91.5 to 96.4)
        Week 44
    93.2 (90.7 to 95.7)
    94.5 (92.2 to 96.8)
        Week 48
    92.4 (89.7 to 95.0)
    93.9 (91.5 to 96.4)
        Week 52
    92.9 (90.3 to 95.5)
    95.0 (92.8 to 97.2)
        Week 56
    91.3 (88.4 to 94.1)
    93.6 (91.2 to 96.1)
        Week 60
    92.1 (89.4 to 94.8)
    94.5 (92.2 to 96.8)
        Week 64
    92.9 (90.3 to 95.5)
    93.9 (91.5 to 96.4)
        Week 68
    92.6 (90.0 to 95.3)
    94.2 (91.8 to 96.6)
        Week 72
    92.6 (90.0 to 95.3)
    93.7 (91.2 to 96.1)
    No statistical analyses for this end point

    Secondary: Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA from Baseline in the Study Eye at Specified Timepoints Through Week 72

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    End point title
    Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA from Baseline in the Study Eye at Specified Timepoints Through Week 72
    End point description
    Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
    End point values
    Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2) Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)
    Number of subjects analysed
    366
    363
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 4
    97.0 (95.3 to 98.7)
    98.1 (96.7 to 99.5)
        Week 8
    96.2 (94.2 to 98.1)
    96.4 (94.5 to 98.3)
        Week 12
    95.9 (93.9 to 97.9)
    96.1 (94.2 to 98.1)
        Week 16
    95.4 (93.2 to 97.5)
    94.8 (92.5 to 97.0)
        Week 20
    94.8 (92.6 to 97.1)
    93.9 (91.5 to 96.4)
        Week 24
    94.0 (91.6 to 96.4)
    93.7 (91.2 to 96.1)
        Week 28
    92.4 (89.7 to 95.1)
    91.7 (88.9 to 94.5)
        Week 32
    91.3 (88.4 to 94.1)
    94.8 (92.5 to 97.0)
        Week 36
    92.7 (90.0 to 95.3)
    94.2 (91.8 to 96.6)
        Week 40
    91.0 (88.1 to 93.9)
    92.6 (89.9 to 95.2)
        Week 44
    90.7 (87.8 to 93.6)
    92.8 (90.2 to 95.4)
        Week 48
    91.0 (88.1 to 93.9)
    92.6 (89.9 to 95.2)
        Week 52
    90.5 (87.5 to 93.4)
    93.4 (90.9 to 95.9)
        Week 56
    88.5 (85.3 to 91.7)
    91.4 (88.6 to 94.3)
        Week 60
    90.5 (87.5 to 93.4)
    92.3 (89.6 to 95.0)
        Week 64
    90.7 (87.8 to 93.7)
    91.2 (88.3 to 94.1)
        Week 68
    89.6 (86.6 to 92.7)
    91.7 (88.9 to 94.5)
        Week 72
    90.5 (87.5 to 93.4)
    90.6 (87.7 to 93.6)
    No statistical analyses for this end point

    Secondary: Parts 1 and 2: Percentage of Participants Achieving ≥84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72

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    End point title
    Parts 1 and 2: Percentage of Participants Achieving ≥84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
    End point description
    Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
    End point values
    Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2) Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)
    Number of subjects analysed
    366
    363
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 4
    6.0 (3.6 to 8.4)
    4.7 (2.6 to 6.8)
        Week 8
    8.7 (5.9 to 11.5)
    10.2 (7.2 to 13.2)
        Week 12
    10.9 (7.8 to 14.0)
    11.9 (8.7 to 15.0)
        Week 16
    11.5 (8.4 to 14.6)
    14.1 (10.7 to 17.5)
        Week 20
    14.2 (10.9 to 17.6)
    14.9 (11.4 to 18.3)
        Week 24
    14.5 (11.0 to 17.9)
    15.2 (11.7 to 18.7)
        Week 28
    9.8 (6.9 to 12.8)
    12.7 (9.5 to 15.9)
        Week 32
    13.4 (10.0 to 16.7)
    14.9 (11.4 to 18.3)
        Week 36
    15.3 (11.8 to 18.8)
    14.9 (11.5 to 18.3)
        Week 40
    14.8 (11.3 to 18.2)
    12.4 (9.2 to 15.7)
        Week 44
    15.5 (12.0 to 19.1)
    14.1 (10.7 to 17.5)
        Week 48
    15.0 (11.6 to 18.5)
    14.6 (11.2 to 18.0)
        Week 52
    16.7 (13.0 to 20.3)
    14.9 (11.4 to 18.4)
        Week 56
    14.8 (11.3 to 18.2)
    15.5 (12.0 to 18.9)
        Week 60
    15.8 (12.3 to 19.4)
    16.3 (12.7 to 19.9)
        Week 64
    16.1 (12.5 to 19.8)
    15.7 (12.2 to 19.3)
        Week 68
    15.3 (11.8 to 18.9)
    15.2 (11.7 to 18.7)
        Week 72
    15.3 (11.8 to 18.8)
    14.4 (11.0 to 17.7)
    No statistical analyses for this end point

    Secondary: Parts 1 and 2: Percentage of Participants Achieving ≥69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72

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    End point title
    Parts 1 and 2: Percentage of Participants Achieving ≥69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
    End point description
    Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
    End point values
    Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2) Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)
    Number of subjects analysed
    366
    363
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 4
    45.0 (41.0 to 49.1)
    46.1 (41.9 to 50.2)
        Week 8
    48.6 (44.3 to 52.8)
    54.6 (50.5 to 58.7)
        Week 12
    54.9 (50.8 to 58.9)
    55.7 (51.4 to 60.0)
        Week 16
    54.9 (50.6 to 59.1)
    59.3 (55.2 to 63.4)
        Week 20
    54.1 (49.7 to 58.4)
    57.6 (53.4 to 61.8)
        Week 24
    55.7 (51.3 to 60.0)
    59.0 (54.5 to 63.4)
        Week 28
    53.2 (48.8 to 57.7)
    56.2 (51.8 to 60.7)
        Week 32
    56.0 (51.6 to 60.4)
    60.4 (56.1 to 64.6)
        Week 36
    53.8 (49.4 to 58.2)
    60.7 (56.3 to 65.0)
        Week 40
    51.9 (47.3 to 56.4)
    56.2 (51.7 to 60.8)
        Week 44
    53.0 (48.4 to 57.6)
    60.9 (56.5 to 65.3)
        Week 48
    56.2 (51.8 to 60.7)
    60.6 (56.2 to 65.1)
        Week 52
    54.3 (49.8 to 58.9)
    60.4 (55.9 to 64.8)
        Week 56
    51.9 (47.3 to 56.4)
    58.7 (54.3 to 63.2)
        Week 60
    56.0 (51.5 to 60.4)
    58.7 (54.3 to 63.1)
        Week 64
    56.5 (52.1 to 61.0)
    57.9 (53.4 to 62.4)
        Week 68
    56.0 (51.5 to 60.4)
    57.9 (53.4 to 62.4)
        Week 72
    56.2 (51.7 to 60.8)
    58.5 (53.9 to 63.1)
    No statistical analyses for this end point

    Secondary: Parts 1 and 2: Percentage of Participants with ≤38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72

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    End point title
    Parts 1 and 2: Percentage of Participants with ≤38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
    End point description
    Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (>38 and ≤38 letters) and region (U.S. and Canada, Asia, and rest of the world). All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
    End point values
    Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2) Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)
    Number of subjects analysed
    366
    363
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 4
    10.0 (7.3 to 12.8)
    8.6 (6.1 to 11.1)
        Week 8
    8.2 (5.5 to 10.8)
    7.0 (4.6 to 9.4)
        Week 12
    7.3 (4.9 to 9.8)
    6.4 (4.0 to 8.8)
        Week 16
    7.8 (5.3 to 10.4)
    6.2 (3.8 to 8.5)
        Week 20
    8.4 (5.7 to 11.0)
    6.4 (4.0 to 8.8)
        Week 24
    10.1 (7.1 to 13.0)
    7.5 (4.9 to 10.1)
        Week 28
    8.9 (6.1 to 11.7)
    9.4 (6.6 to 12.3)
        Week 32
    9.2 (6.4 to 12.0)
    8.0 (5.4 to 10.7)
        Week 36
    9.5 (6.6 to 12.4)
    8.3 (5.7 to 11.0)
        Week 40
    9.8 (6.8 to 12.7)
    7.5 (4.9 to 10.1)
        Week 44
    10.6 (7.5 to 13.6)
    8.3 (5.6 to 11.0)
        Week 48
    10.0 (7.1 to 13.0)
    7.5 (4.9 to 10.1)
        Week 52
    11.4 (8.3 to 14.5)
    7.2 (4.7 to 9.8)
        Week 56
    11.9 (8.8 to 15.1)
    8.6 (5.8 to 11.4)
        Week 60
    11.4 (8.3 to 14.5)
    8.3 (5.7 to 11.0)
        Week 64
    11.1 (8.0 to 14.2)
    8.3 (5.6 to 11.0)
        Week 68
    11.2 (8.0 to 14.3)
    8.3 (5.6 to 11.0)
        Week 72
    11.4 (8.3 to 14.6)
    8.0 (5.4 to 10.7)
    No statistical analyses for this end point

    Secondary: Parts 1 and 2: Change from Baseline in NEI VFQ-25 Questionnaire Composite Score at Specified Timepoints Through Week 72

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    End point title
    Parts 1 and 2: Change from Baseline in NEI VFQ-25 Questionnaire Composite Score at Specified Timepoints Through Week 72
    End point description
    The NEI VFQ-25 captures a patient’s perception of vision-related functioning and vision-related quality of life. The core measure includes 25 items that comprise 11 vision-related subscales and 1 item on general health. The composite score ranges from 0 to 100, with higher scores indicating better vision-related functioning. For the MMRM analysis, the model adjusted for the treatment group, visit, visit-by-treatment group interaction, baseline NEI VFQ-25 Composite Score continuous), baseline BCVA score (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and the rest of the world). Observed NEI VFQ-25 assessments were used regardless of the occurrence of intercurrent events. Missing data were implicitly imputed. Invalid BCVA values were excluded. 95% CI is a rounding of 95.03% CI.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 24, 48, and 72
    End point values
    Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2) Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)
    Number of subjects analysed
    366
    363
    Units: score on a scale
    arithmetic mean (confidence interval 95%)
        Week 24
    7.0 (5.9 to 8.0)
    8.2 (7.1 to 9.3)
        Week 48
    7.0 (5.9 to 8.2)
    8.3 (7.1 to 9.5)
        Week 72
    7.8 (6.5 to 9.0)
    8.5 (7.3 to 9.8)
    No statistical analyses for this end point

    Secondary: Parts 1 and 2: Change from Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72

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    End point title
    Parts 1 and 2: Change from Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72
    End point description
    Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE) using optical coherence tomography (OCT), as assessed by the central reading center. The Mixed Model of Repeated Measures (MMRM) analysis included the categorical covariates of treatment arm, visit, visit-by-treatment arm interaction, baseline CST (continuous), and randomization stratification factors [baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)] as fixed effects. An unstructured covariance structure was used. Missing data were implicitly imputed by MMRM model assuming missing at random. Treatment policy strategy (i.e., all observed values used) was applied to all intercurrent events (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). 95% CI is a rounding of 95.03% CI.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
    End point values
    Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2) Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)
    Number of subjects analysed
    366
    363
    Units: microns
    arithmetic mean (confidence interval 95%)
        Week 4
    -422.1 (-430.6 to -413.7)
    -418.2 (-426.6 to -409.7)
        Week 8
    -445.1 (-453.6 to -436.6)
    -438.5 (-447.0 to -429.9)
        Week 12
    -452.3 (-461.8 to -442.8)
    -443.7 (-453.2 to -434.1)
        Week 16
    -453.8 (-463.1 to -444.5)
    -446.2 (-455.5 to -436.9)
        Week 20
    -460.0 (-468.1 to -451.8)
    -447.1 (-455.4 to -438.9)
        Week 24
    -462.3 (-472.3 to -452.3)
    -447.8 (-457.9 to -437.8)
        Week 28
    -415.5 (-431.8 to -399.1)
    -413.7 (-430.3 to -397.2)
        Week 32
    -459.4 (-468.7 to -450.1)
    -445.8 (-455.3 to -436.3)
        Week 36
    -451.7 (-462.7 to -440.8)
    -441.8 (-452.9 to -430.8)
        Week 40
    -409.8 (-425.6 to -394.0)
    -414.0 (-429.9 to -398.0)
        Week 44
    -456.6 (-467.1 to -446.0)
    -449.8 (-460.6 to -439.0)
        Week 48
    -461.2 (-471.3 to -451.1)
    -448.0 (-458.3 to -437.7)
        Week 52
    -446.0 (-457.0 to -435.0)
    -451.8 (-462.9 to -440.7)
        Week 56
    -435.9 (-449.8 to -422.0)
    -426.2 (-440.3 to -412.1)
        Week 60
    -468.2 (-476.8 to -459.5)
    -458.9 (-467.6 to -450.1)
        Week 64
    -466.6 (-473.7 to -459.5)
    -465.5 (-472.6 to -458.3)
        Week 68
    -467.5 (-476.0 to -459.1)
    -457.7 (-466.2 to -449.2)
        Week 72
    -463.5 (-472.8 to -454.3)
    -458.6 (-467.9 to -449.2)
    No statistical analyses for this end point

    Secondary: Parts 1 and 2: Percentage of Participants with Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72

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    End point title
    Parts 1 and 2: Percentage of Participants with Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72
    End point description
    Absence of diabetic macular edema was defined as achieving a central subfield thickness of <325 microns in the study eye. Central subfield thickness was defined as the distance between the internal limiting membrane (ILM) and Bruch's membrane (BM) as assessed by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
    End point values
    Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2) Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)
    Number of subjects analysed
    366
    363
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 4
    83.8 (80.2 to 87.5)
    82.4 (78.5 to 86.2)
        Week 8
    92.6 (90.0 to 95.2)
    91.2 (88.3 to 94.1)
        Week 12
    93.4 (90.9 to 95.9)
    91.5 (88.6 to 94.3)
        Week 16
    94.5 (92.2 to 96.8)
    92.8 (90.2 to 95.5)
        Week 20
    94.5 (92.2 to 96.8)
    93.1 (90.5 to 95.7)
        Week 24
    93.7 (91.2 to 96.2)
    91.7 (88.9 to 94.5)
        Week 28
    82.5 (78.6 to 86.4)
    84.0 (80.3 to 87.7)
        Week 32
    93.2 (90.6 to 95.7)
    90.3 (87.4 to 93.3)
        Week 36
    91.8 (89.0 to 94.6)
    89.5 (86.4 to 92.6)
        Week 40
    80.0 (76.0 to 84.1)
    80.7 (76.7 to 84.7)
        Week 44
    93.2 (90.6 to 95.7)
    90.9 (88.0 to 93.8)
        Week 48
    92.6 (89.9 to 95.3)
    89.8 (86.7 to 92.9)
        Week 52
    88.5 (85.2 to 91.8)
    90.9 (88.0 to 93.8)
        Week 56
    87.4 (84.1 to 90.8)
    84.3 (80.6 to 88.0)
        Week 60
    93.7 (91.3 to 96.2)
    92.8 (90.2 to 95.5)
        Week 64
    94.3 (91.9 to 96.6)
    93.4 (90.8 to 95.9)
        Week 68
    93.2 (90.6 to 95.7)
    91.4 (88.6 to 94.3)
        Week 72
    92.4 (89.6 to 95.1)
    91.2 (88.3 to 94.0)
    No statistical analyses for this end point

    Secondary: Parts 1 and 2: Percentage of Participants with Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72

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    End point title
    Parts 1 and 2: Percentage of Participants with Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
    End point description
    Intraretinal fluid was measured in the study eye using optical coherence tomography (OCT) in the central subfield (center 1 mm) by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
    End point values
    Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2) Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)
    Number of subjects analysed
    366
    363
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 4
    45.5 (40.6 to 50.5)
    40.6 (35.8 to 45.3)
        Week 8
    63.1 (58.3 to 68.0)
    61.7 (56.9 to 66.6)
        Week 12
    53.2 (48.3 to 58.2)
    51.0 (46.2 to 55.9)
        Week 16
    55.4 (50.5 to 60.3)
    51.9 (46.8 to 56.9)
        Week 20
    59.0 (54.0 to 63.9)
    56.5 (51.6 to 61.5)
        Week 24
    77.0 (72.8 to 81.3)
    70.8 (66.2 to 75.4)
        Week 28
    53.8 (48.7 to 58.9)
    51.5 (46.4 to 56.6)
        Week 32
    67.7 (63.1 to 72.4)
    67.2 (62.5 to 72.0)
        Week 36
    62.8 (58.1 to 67.5)
    57.6 (52.6 to 62.6)
        Week 40
    52.7 (47.7 to 57.7)
    51.0 (46.0 to 56.1)
        Week 44
    66.4 (61.6 to 71.2)
    63.4 (58.5 to 68.3)
        Week 48
    74.3 (69.9 to 78.8)
    69.7 (65.0 to 74.3)
        Week 52
    66.9 (62.2 to 71.6)
    63.4 (58.5 to 68.2)
        Week 56
    60.9 (56.0 to 65.9)
    58.7 (53.7 to 63.6)
        Week 60
    71.6 (67.0 to 76.1)
    72.7 (68.2 to 77.2)
        Week 64
    76.5 (72.2 to 80.8)
    72.7 (68.2 to 77.2)
        Week 68
    74.6 (70.2 to 79.0)
    71.3 (66.8 to 75.9)
        Week 72
    78.1 (73.9 to 82.3)
    74.4 (69.9 to 78.9)
    No statistical analyses for this end point

    Secondary: Parts 1 and 2: Percentage of Participants with Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72

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    End point title
    Parts 1 and 2: Percentage of Participants with Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
    End point description
    Subretinal fluid was measured in the study eye using optical coherence tomography (OCT) in the central subfield (center 1 mm) by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
    End point values
    Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2) Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)
    Number of subjects analysed
    366
    363
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 4
    66.1 (61.4 to 70.8)
    65.0 (60.3 to 69.7)
        Week 8
    89.6 (86.5 to 92.6)
    90.1 (87.0 to 93.1)
        Week 12
    94.0 (91.6 to 96.4)
    93.9 (91.5 to 96.4)
        Week 16
    95.3 (93.2 to 97.5)
    95.6 (93.5 to 97.7)
        Week 20
    95.9 (93.9 to 97.9)
    94.5 (92.2 to 96.8)
        Week 24
    96.2 (94.2 to 98.1)
    93.4 (90.8 to 95.9)
        Week 28
    89.3 (86.2 to 92.5)
    90.1 (87.0 to 93.1)
        Week 32
    95.6 (93.6 to 97.7)
    94.5 (92.2 to 96.8)
        Week 36
    95.1 (92.9 to 97.3)
    92.3 (89.6 to 95.0)
        Week 40
    89.6 (86.5 to 92.7)
    89.3 (86.1 to 92.4)
        Week 44
    95.4 (93.2 to 97.5)
    92.8 (90.2 to 95.5)
        Week 48
    93.4 (90.9 to 95.9)
    89.5 (86.4 to 92.6)
        Week 52
    92.6 (89.9 to 95.3)
    93.6 (91.2 to 96.1)
        Week 56
    93.4 (90.9 to 95.9)
    90.1 (87.1 to 93.1)
        Week 60
    97.0 (95.3 to 98.7)
    94.8 (92.5 to 97.0)
        Week 64
    96.7 (94.9 to 98.5)
    95.9 (93.8 to 97.9)
        Week 68
    97.6 (96.0 to 99.1)
    93.9 (91.6 to 96.3)
        Week 72
    95.4 (93.2 to 97.5)
    93.1 (90.6 to 95.7)
    No statistical analyses for this end point

    Secondary: Parts 1 and 2: Percentage of Participants with Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72

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    End point title
    Parts 1 and 2: Percentage of Participants with Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
    End point description
    Intraretinal fluid and subretinal fluid were measured in the study eye using optical coherence tomography (OCT) in the central subfield (center 1 mm) by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
    End point values
    Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2) Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)
    Number of subjects analysed
    366
    363
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 4
    33.0 (28.3 to 37.6)
    29.3 (24.9 to 33.7)
        Week 8
    59.3 (54.4 to 64.1)
    59.3 (54.3 to 64.2)
        Week 12
    52.7 (47.7 to 57.6)
    50.2 (45.3 to 55.1)
        Week 16
    54.9 (49.9 to 59.8)
    51.3 (46.3 to 56.3)
        Week 20
    58.2 (53.2 to 63.1)
    55.4 (50.5 to 60.4)
        Week 24
    76.0 (71.6 to 80.3)
    68.6 (63.8 to 73.4)
        Week 28
    52.7 (47.6 to 57.8)
    51.2 (46.1 to 56.3)
        Week 32
    67.2 (62.6 to 71.8)
    66.4 (61.6 to 71.2)
        Week 36
    62.8 (58.1 to 67.5)
    56.5 (51.5 to 61.5)
        Week 40
    52.7 (47.7 to 57.7)
    50.2 (45.1 to 55.2)
        Week 44
    64.7 (59.9 to 69.6)
    60.9 (56.0 to 65.8)
        Week 48
    70.8 (66.1 to 75.4)
    65.8 (61.0 to 70.6)
        Week 52
    65.8 (61.1 to 70.6)
    61.7 (56.8 to 66.6)
        Week 56
    60.7 (55.7 to 65.6)
    58.1 (53.2 to 63.0)
        Week 60
    71.0 (66.4 to 75.6)
    71.6 (67.0 to 76.2)
        Week 64
    75.4 (71.1 to 79.8)
    71.9 (67.3 to 76.4)
        Week 68
    74.3 (69.9 to 78.8)
    70.8 (66.2 to 75.3)
        Week 72
    77.0 (72.8 to 81.3)
    71.6 (67.0 to 76.3)
    No statistical analyses for this end point

    Secondary: Part 2: Change from Week 24 in BCVA in the Study Eye at Specified Timepoints Through Week 72

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    End point title
    Part 2: Change from Week 24 in BCVA in the Study Eye at Specified Timepoints Through Week 72
    End point description
    Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The Mixed Model of Repeated Measures (MMRM) analysis included the categorical covariates of treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), and randomization stratification factors [baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)] as fixed effects. An unstructured covariance structure was used. Missing data were implicitly imputed by MMRM model assuming missing at random. Treatment policy strategy (i.e., all observed values used) was applied to all intercurrent events (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). 95% CI is a rounding of 95.03% CI.
    End point type
    Secondary
    End point timeframe
    Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
    End point values
    Arm A: Faricimab Q4W to Faricimab PTI (Part 2) Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
    Number of subjects analysed
    340
    331
    Units: ETDRS Letters
    arithmetic mean (confidence interval 95%)
        Week 28
    -0.8 (-1.6 to 0.0)
    -1.2 (-2.0 to -0.4)
        Week 32
    0.2 (-0.6 to 0.9)
    0.2 (-0.6 to 1.0)
        Week 36
    -0.1 (-0.8 to 0.7)
    0.1 (-0.7 to 0.9)
        Week 40
    -1.3 (-2.4 to -0.2)
    -1.4 (-2.4 to -0.3)
        Week 44
    -0.6 (-1.6 to 0.4)
    0.0 (-1.0 to 1.0)
        Week 48
    -0.1 (-1.1 to 0.9)
    0.2 (-0.8 to 1.1)
        Week 52
    -0.6 (-1.6 to 0.4)
    0.3 (-0.6 to 1.3)
        Week 56
    -1.1 (-2.1 to 0.0)
    -0.6 (-1.7 to 0.5)
        Week 60
    0.0 (-1.1 to 1.0)
    -0.1 (-1.2 to 0.9)
        Week 64
    -0.2 (-1.3 to 0.8)
    -0.2 (-1.3 to 0.9)
        Week 68
    -0.1 (-1.2 to 1.0)
    -0.5 (-1.6 to 0.6)
        Week 72
    -0.2 (-1.3 to 1.0)
    -0.3 (-1.5 to 0.8)
    No statistical analyses for this end point

    Secondary: Part 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Week 24 in the Study Eye at Specified Timepoints Through Week 72

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    End point title
    Part 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Week 24 in the Study Eye at Specified Timepoints Through Week 72
    End point description
    Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
    End point type
    Secondary
    End point timeframe
    Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
    End point values
    Arm A: Faricimab Q4W to Faricimab PTI (Part 2) Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
    Number of subjects analysed
    366
    363
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 28
    86.3 (82.9 to 89.8)
    83.8 (80.0 to 87.5)
        Week 32
    88.8 (85.6 to 92.0)
    87.9 (84.6 to 91.2)
        Week 36
    89.3 (86.2 to 92.5)
    87.9 (84.6 to 91.2)
        Week 40
    87.4 (84.0 to 90.8)
    86.0 (82.4 to 89.5)
        Week 44
    87.4 (84.0 to 90.8)
    88.4 (85.2 to 91.7)
        Week 48
    88.5 (85.3 to 91.7)
    87.3 (83.9 to 90.7)
        Week 52
    86.3 (82.8 to 89.8)
    87.6 (84.2 to 91.0)
        Week 56
    85.7 (82.2 to 89.3)
    85.4 (81.8 to 89.0)
        Week 60
    87.7 (84.3 to 91.0)
    86.2 (82.7 to 89.8)
        Week 64
    86.3 (82.8 to 89.8)
    85.9 (82.4 to 89.5)
        Week 68
    87.1 (83.7 to 90.5)
    85.4 (81.8 to 89.0)
        Week 72
    86.6 (83.1 to 90.0)
    84.0 (80.3 to 87.8)
    No statistical analyses for this end point

    Secondary: Part 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA from Week 24 in the Study Eye at Specified Timepoints Through Week 72

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    End point title
    Part 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA from Week 24 in the Study Eye at Specified Timepoints Through Week 72
    End point description
    Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
    End point type
    Secondary
    End point timeframe
    Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
    End point values
    Arm A: Faricimab Q4W to Faricimab PTI (Part 2) Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
    Number of subjects analysed
    366
    363
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 28
    82.8 (79.0 to 86.6)
    81.3 (77.3 to 85.2)
        Week 32
    87.1 (83.7 to 90.6)
    86.0 (82.4 to 89.5)
        Week 36
    84.7 (81.0 to 88.4)
    85.4 (81.8 to 89.0)
        Week 40
    82.8 (78.9 to 86.6)
    81.6 (77.6 to 85.5)
        Week 44
    84.1 (80.4 to 87.9)
    86.8 (83.4 to 90.2)
        Week 48
    84.4 (80.7 to 88.1)
    84.8 (81.2 to 88.5)
        Week 52
    82.8 (78.9 to 86.6)
    85.4 (81.8 to 89.0)
        Week 56
    80.0 (76.0 to 84.1)
    81.8 (77.9 to 85.8)
        Week 60
    83.6 (79.8 to 87.4)
    82.6 (78.8 to 86.5)
        Week 64
    81.7 (77.7 to 85.6)
    83.2 (79.4 to 87.0)
        Week 68
    82.2 (78.3 to 86.1)
    80.7 (76.7 to 84.7)
        Week 72
    82.5 (78.6 to 86.3)
    80.7 (76.7 to 84.7)
    No statistical analyses for this end point

    Secondary: Part 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA from Week 24 in the Study Eye at Specified Timepoints Through Week 72

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    End point title
    Part 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA from Week 24 in the Study Eye at Specified Timepoints Through Week 72
    End point description
    Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
    End point type
    Secondary
    End point timeframe
    Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
    End point values
    Arm A: Faricimab Q4W to Faricimab PTI (Part 2) Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
    Number of subjects analysed
    366
    363
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 28
    72.7 (68.2 to 77.2)
    69.7 (65.0 to 74.4)
        Week 32
    78.4 (74.2 to 82.6)
    75.5 (71.1 to 79.9)
        Week 36
    74.1 (69.6 to 78.5)
    80.2 (76.1 to 84.2)
        Week 40
    71.0 (66.4 to 75.6)
    71.6 (67.0 to 76.2)
        Week 44
    73.7 (69.3 to 78.2)
    73.0 (68.5 to 77.6)
        Week 48
    76.5 (72.2 to 80.8)
    74.1 (69.6 to 78.6)
        Week 52
    71.3 (66.7 to 75.9)
    74.1 (69.6 to 78.6)
        Week 56
    69.4 (64.7 to 74.1)
    68.3 (63.6 to 73.1)
        Week 60
    74.3 (69.8 to 78.7)
    71.6 (67.0 to 76.2)
        Week 64
    74.6 (70.1 to 79.0)
    71.6 (67.0 to 76.2)
        Week 68
    73.2 (68.7 to 77.7)
    69.2 (64.5 to 73.8)
        Week 72
    72.9 (68.4 to 77.5)
    70.3 (65.6 to 74.9)
    No statistical analyses for this end point

    Secondary: Part 2: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA from Week 24 in the Study Eye at Specified Timepoints Through Week 72

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    End point title
    Part 2: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA from Week 24 in the Study Eye at Specified Timepoints Through Week 72
    End point description
    Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
    End point type
    Secondary
    End point timeframe
    Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
    End point values
    Arm A: Faricimab Q4W to Faricimab PTI (Part 2) Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
    Number of subjects analysed
    366
    363
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 28
    48.9 (43.8 to 54.0)
    45.4 (40.4 to 50.5)
        Week 32
    56.0 (50.9 to 61.1)
    52.9 (47.8 to 58.0)
        Week 36
    55.5 (50.4 to 60.5)
    55.1 (50.0 to 60.2)
        Week 40
    53.0 (47.9 to 58.0)
    48.2 (43.1 to 53.3)
        Week 44
    53.0 (47.9 to 58.0)
    54.0 (49.0 to 59.1)
        Week 48
    56.5 (51.5 to 61.6)
    53.5 (48.4 to 58.6)
        Week 52
    56.0 (50.9 to 61.1)
    56.5 (51.4 to 61.5)
        Week 56
    54.9 (49.8 to 60.0)
    53.2 (48.1 to 58.2)
        Week 60
    55.9 (50.9 to 61.0)
    51.0 (45.9 to 56.1)
        Week 64
    54.6 (49.5 to 59.7)
    52.1 (47.0 to 57.2)
        Week 68
    55.4 (50.4 to 60.4)
    52.3 (47.3 to 57.4)
        Week 72
    55.4 (50.4 to 60.5)
    52.7 (47.6 to 57.7)
    No statistical analyses for this end point

    Secondary: Part 2: Percentage of Participants on Different Treatment Intervals at Week 68

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    End point title
    Part 2: Percentage of Participants on Different Treatment Intervals at Week 68
    End point description
    In Part 2 of the study, participants in both the faricimab Q4W and aflibercept Q4W arms in Part 1 received 6 mg faricimab intravitreal injections administered according to a personalized treatment interval (PTI) dosing regimen in intervals between Q4W and Q16W. At faricimab dosing visits, treatment intervals were maintained or adjusted (i.e., increased by 4 weeks or decreased by 4, 8, or 12 weeks), based on central subfield thickness (CST) and BCVA values.
    End point type
    Secondary
    End point timeframe
    Week 68
    End point values
    Arm A: Faricimab Q4W to Faricimab PTI (Part 2) Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
    Number of subjects analysed
    330
    315
    Units: Percentage of participants
    number (confidence interval 95%)
        Once Every 4 Weeks (Q4W)
    34.5 (29.4 to 39.7)
    32.4 (27.2 to 37.6)
        Once Every 8 Weeks (Q8W)
    20.0 (15.7 to 24.3)
    17.5 (13.3 to 21.7)
        Once Every 12 Weeks (Q12W)
    8.5 (5.5 to 11.5)
    11.1 (7.6 to 14.6)
        Once Every 16 Weeks (Q16W)
    37.0 (31.8 to 42.2)
    39.0 (33.7 to 44.4)
    No statistical analyses for this end point

    Secondary: Incidence and Severity of Ocular Adverse Events in the Study Eye, with Severity Determined According to Adverse Event Severity Grading Scale

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    End point title
    Incidence and Severity of Ocular Adverse Events in the Study Eye, with Severity Determined According to Adverse Event Severity Grading Scale
    End point description
    This analysis of adverse events (AEs) only includes ocular AEs that occurred in the study eye. Investigators sought information on AEs at each contact with the participants. All AEs were recorded and the investigator made an assessment of seriousness, severity, and causality of each AE. Ocular AEs of special interest included the following: Suspected transmission of an infectious agent by the study drug; Sight-threatening AEs that cause a drop in visual acuity (VA) score ≥30 letters lasting more than 1 hour, require surgical or medical intervention to prevent permanent loss of sight, or are associated with severe intraocular inflammation (IOI).
    End point type
    Secondary
    End point timeframe
    Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
    End point values
    Arm A: Faricimab Q4W to Faricimab PTI (Part 2) Arm B: Aflibercept Q4W to Faricimab PTI (Part 2) Arm A: Faricimab Q4W (Part 1) Arm B: Aflibercept Q4W (Part 1)
    Number of subjects analysed
    359
    342
    365
    361
    Units: Participants
        Adverse Event (AE)
    130
    118
    89
    98
        AE by Severity: Mild
    63
    69
    65
    65
        AE by Severity: Moderate
    52
    43
    18
    27
        AE by Severity: Severe
    15
    6
    6
    6
        Serious Adverse Event (SAE)
    26
    12
    9
    13
        AE Leading to Withdrawal from Study Treatment
    5
    3
    3
    2
        Treatment Related AEs
    14
    11
    15
    6
        Treatment Related SAEs
    4
    0
    3
    2
        Any AE of Special Interest (AESI)
    21
    9
    8
    12
        AESI: Drop in Visual Acuity Score ≥30
    15
    7
    6
    6
        AESI: Associated with Severe IOI
    0
    1
    0
    0
        AESI: Interv. Req. to Prevent Perm. Vision Loss
    6
    1
    2
    6
    No statistical analyses for this end point

    Secondary: Part 2: Number of Study Drug Injections Received in the Study Eye from Week 24 Through Week 72

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    End point title
    Part 2: Number of Study Drug Injections Received in the Study Eye from Week 24 Through Week 72
    End point description
    End point type
    Secondary
    End point timeframe
    From Week 24 to Week 72
    End point values
    Arm A: Faricimab Q4W to Faricimab PTI (Part 2) Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
    Number of subjects analysed
    359
    342
    Units: Injections
        median (full range (min-max))
    5.0 (1 to 12)
    4.0 (1 to 12)
    No statistical analyses for this end point

    Secondary: Incidence of Ocular Adverse Events in the Fellow Eye

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    End point title
    Incidence of Ocular Adverse Events in the Fellow Eye
    End point description
    This analysis of adverse events (AEs) only includes ocular AEs that occurred in the fellow eye. Investigators sought information on AEs at each contact with the participants. All AEs were recorded and the investigator made an assessment of seriousness, severity, and causality of each AE. Ocular AEs of special interest included the following: Suspected transmission of an infectious agent by the study drug; Sight-threatening AEs that cause a drop in visual acuity (VA) score ≥30 letters lasting more than 1 hour, require surgical or medical intervention to prevent permanent loss of sight, or are associated with severe intraocular inflammation (IOI).
    End point type
    Secondary
    End point timeframe
    Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
    End point values
    Arm A: Faricimab Q4W to Faricimab PTI (Part 2) Arm B: Aflibercept Q4W to Faricimab PTI (Part 2) Arm A: Faricimab Q4W (Part 1) Arm B: Aflibercept Q4W (Part 1)
    Number of subjects analysed
    359
    342
    365
    361
    Units: Participants
        Adverse Event (AE)
    70
    51
    31
    33
        Serious Adverse Event (SAE)
    1
    0
    1
    1
        Any AE of Special Interest (AESI)
    1
    0
    1
    1
        AESI: Drop in Visual Acuity Score ≥30
    1
    0
    1
    1
    No statistical analyses for this end point

    Secondary: Incidence of Non-Ocular Adverse Events

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    End point title
    Incidence of Non-Ocular Adverse Events
    End point description
    This analysis of adverse events (AEs) only includes non-ocular (systemic) AEs. Investigators sought information on adverse events (AEs) at each contact with the participants. All AEs were recorded and the investigator made an assessment of seriousness, severity, and causality of each AE. The non-ocular AE of special interest was: Cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law.
    End point type
    Secondary
    End point timeframe
    Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
    End point values
    Arm A: Faricimab Q4W to Faricimab PTI (Part 2) Arm B: Aflibercept Q4W to Faricimab PTI (Part 2) Arm A: Faricimab Q4W (Part 1) Arm B: Aflibercept Q4W (Part 1)
    Number of subjects analysed
    359
    342
    365
    361
    Units: Participants
        Adverse Event (AE)
    191
    174
    123
    134
        Serious Adverse Event (SAE)
    30
    41
    22
    23
        AE Leading to Withdrawal from Study Treatment
    3
    3
    0
    1
        Any AE of Special Interest (AESI)
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants with Anti-Drug Antibodies (ADAs) to Faricimab at Baseline and Post-Baseline During the Study

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    End point title
    Number of Participants with Anti-Drug Antibodies (ADAs) to Faricimab at Baseline and Post-Baseline During the Study
    End point description
    Anti-drug antibodies (ADAs) against fariciamb were detected in plasma using a validated bridging enzyme-linked immunosorbent assay (ELISA). The number of participants with treatment-emergent ADA-positive samples includes post-baseline evaluable participants with at least one treatment-induced (defined as having an ADA-negative sample or missing sample at baseline and any positive post-baseline sample) or treatment-boosted (defined as having an ADA-positive sample at baseline and any positive post-baseline sample with a titer that is equal to or greater than 4-fold baseline titer) ADA-positive sample during the study treatment period. Treatment-unaffected ADA-positive is a post-baseline sample with a titer that is lower than 4-fold the ADA-positive baseline titer (faricimab arm) or the ADA-positive titer prior to first faricimab injection (aflibercept arm).
    End point type
    Secondary
    End point timeframe
    Predose at Day 1 (Baseline), Weeks 4, 24, 28, 52, and 72
    End point values
    Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2) Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2) All Faricimab Participants
    Number of subjects analysed
    366
    342
    708
    Units: Participants
        Baseline (BL): Total ADA-Positive
    4
    5
    9
        Post-BL: Total ADA-Positive
    62
    27
    89
        Post-BL: Treatment-Emergent ADA-Positive
    60
    23
    83
        Post-BL: Treatment-Unaffected ADA-Positive
    2
    4
    6
    No statistical analyses for this end point

    Secondary: Plasma Concentration of Faricimab Over Time

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    End point title
    Plasma Concentration of Faricimab Over Time
    End point description
    End point type
    Secondary
    End point timeframe
    Predose at Day 1 (Baseline), Weeks 4, 24, 28, 52, and 72
    End point values
    Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2) Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)
    Number of subjects analysed
    365
    342
    Units: microgram per millilitre (μg/mL)
    arithmetic mean (standard deviation)
        Baseline (n = 359, 0)
    0.0001 ( 0.0009 )
    999999 ( 999999 )
        Week 4 (n = 345, 0)
    0.0222 ( 0.0176 )
    999999 ( 999999 )
        Week 24 (n = 321, 324)
    0.0257 ( 0.0217 )
    0.0005 ( 0.0014 )
        Week 28 (n = 323, 314)
    0.0055 ( 0.0086 )
    0.0026 ( 0.0084 )
        Week 52 (n = 318, 300)
    0.0089 ( 0.0142 )
    0.0090 ( 0.0136 )
        Week 72 (n = 279, 272)
    0.0087 ( 0.0140 )
    0.0099 ( 0.0167 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
    Adverse event reporting additional description
    Safety analysis population: all subjects who received ≥1 study drug injection (faricimab or aflibercept). For Part 2, this included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. The eye type (study/fellow) in which an ocular AE had occurred is specified.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Arm A: Faricimab Q4W (Part 1)
    Reporting group description
    In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).

    Reporting group title
    Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
    Reporting group description
    In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).

    Reporting group title
    Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
    Reporting group description
    In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).

    Reporting group title
    Arm B: Aflibercept Q4W (Part 1)
    Reporting group description
    In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).

    Serious adverse events
    Arm A: Faricimab Q4W (Part 1) Arm B: Aflibercept Q4W to Faricimab PTI (Part 2) Arm A: Faricimab Q4W to Faricimab PTI (Part 2) Arm B: Aflibercept Q4W (Part 1)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    32 / 365 (8.77%)
    51 / 342 (14.91%)
    55 / 359 (15.32%)
    34 / 361 (9.42%)
         number of deaths (all causes)
    1
    1
    4
    2
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Gastric cancer
         subjects affected / exposed
    1 / 365 (0.27%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder adenocarcinoma stage unspecified
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of the oral cavity
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder cancer
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign neoplasm of thyroid gland
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thyroid cancer
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Papillary thyroid cancer
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertensive crisis
         subjects affected / exposed
    1 / 365 (0.27%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic stenosis
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic dissection
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Aortic aneurysm
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Secondary hypertension
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery aneurysm
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Knee operation
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal transplant
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ligament operation
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Stent-graft endoleak
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    0 / 365 (0.00%)
    2 / 342 (0.58%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    2 / 359 (0.56%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    Chest pain
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    1 / 359 (0.28%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Uterine haemorrhage
         subjects affected / exposed
    1 / 365 (0.27%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystocele
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 365 (0.27%)
    1 / 342 (0.29%)
    1 / 359 (0.28%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pickwickian syndrome
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 365 (0.27%)
    1 / 342 (0.29%)
    1 / 359 (0.28%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary hypertension
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Obstructive sleep apnoea syndrome
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Intraocular pressure increased
    Additional description: AEs occurred in the study eye
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Eye injury
    Additional description: AEs occurred in the study eye
         subjects affected / exposed
    1 / 365 (0.27%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    1 / 365 (0.27%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Shunt occlusion
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fracture
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 365 (0.00%)
    2 / 342 (0.58%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Shunt stenosis
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 365 (0.27%)
    2 / 342 (0.58%)
    0 / 359 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    1 / 365 (0.27%)
    0 / 342 (0.00%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    3 / 359 (0.84%)
    3 / 361 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    Cardiac failure congestive
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    2 / 359 (0.56%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic valve incompetence
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 365 (0.00%)
    2 / 342 (0.58%)
    2 / 359 (0.56%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stress cardiomyopathy
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Altered state of consciousness
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    2 / 365 (0.55%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    2 / 3
    1 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral sensorimotor neuropathy
         subjects affected / exposed
    1 / 365 (0.27%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 365 (0.27%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 365 (0.00%)
    2 / 342 (0.58%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Deficiency anaemia
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mesenteric lymphadenitis
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Cystoid macular oedema
    Additional description: AEs occurred in the study eye
         subjects affected / exposed
    2 / 365 (0.55%)
    1 / 342 (0.29%)
    5 / 359 (1.39%)
    2 / 361 (0.55%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Macular ischaemia
    Additional description: AEs occurred in the study eye
         subjects affected / exposed
    1 / 365 (0.27%)
    0 / 342 (0.00%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-infectious endophthalmitis
    Additional description: AEs occurred in the study eye
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal tear
    Additional description: AEs occurred in the study eye
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    1 / 359 (0.28%)
    2 / 361 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal artery occlusion
    Additional description: AEs occurred in the study eye
         subjects affected / exposed
    2 / 365 (0.55%)
    2 / 342 (0.58%)
    0 / 359 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal ischaemia
    Additional description: AEs occurred in the study eye
         subjects affected / exposed
    1 / 365 (0.27%)
    0 / 342 (0.00%)
    1 / 359 (0.28%)
    2 / 361 (0.55%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal artery embolism
    Additional description: AEs occurred in the study eye
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    1 / 359 (0.28%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rhegmatogenous retinal detachment
    Additional description: AEs occurred in the study eye
         subjects affected / exposed
    1 / 365 (0.27%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uveitis
    Additional description: AEs occurred in the study eye
         subjects affected / exposed
    2 / 365 (0.55%)
    0 / 342 (0.00%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Visual acuity reduced
    Additional description: AEs occurred in the study eye
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vitreous haemorrhage
    Additional description: AEs occurred in the study eye
         subjects affected / exposed
    1 / 365 (0.27%)
    0 / 342 (0.00%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epiretinal membrane
    Additional description: AEs occurred in the study eye
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Glaucoma
    Additional description: AEs occurred in the study eye
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Iridocyclitis
    Additional description: AEs occurred in the study eye
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Iris neovascularisation
    Additional description: AEs occurred in the study eye
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Macular hole
    Additional description: AEs occurred in the study eye
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Posterior capsule opacification
    Additional description: AEs occurred in the study eye
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal detachment
    Additional description: AEs occurred in the study eye
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal neovascularisation
    Additional description: AEs occurred in the study eye
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vitritis
    Additional description: AEs occurred in the study eye
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cataract
    Additional description: AEs occurred in the fellow eye (Arm A, Part 1) and the study eye (Arm B, Part 2).
         subjects affected / exposed
    1 / 365 (0.27%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Macular oedema
    Additional description: All AEs occurred in the study eye, except for 1 subject had 1 event in the fellow eye (Arm A, Part 2).
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    5 / 359 (1.39%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal vein occlusion
    Additional description: All AEs occurred in the study eye, except for 1 subject had 1 event in the fellow eye (Arm B, Part 1).
         subjects affected / exposed
    2 / 365 (0.55%)
    3 / 342 (0.88%)
    5 / 359 (1.39%)
    3 / 361 (0.83%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Duodenal bulb deformity
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis erosive
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    2 / 365 (0.55%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Obstructive pancreatitis
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peptic ulcer
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenitis
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestine polyp
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal inflammation
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulum intestinal haemorrhagic
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stone
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gallbladder disorder
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic steatosis
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Diabetic foot
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    1 / 359 (0.28%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus urinary
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    1 / 365 (0.27%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urethral stenosis
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystitis interstitial
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    End stage renal disease
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic nephropathy
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephropathy
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Thyroid mass
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 365 (0.27%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    1 / 365 (0.27%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint effusion
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mobility decreased
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polymyositis
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    3 / 365 (0.82%)
    0 / 342 (0.00%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis acute
         subjects affected / exposed
    1 / 365 (0.27%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 365 (0.55%)
    2 / 342 (0.58%)
    3 / 359 (0.84%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Endophthalmitis
    Additional description: AEs occurred in the study eye
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 365 (0.27%)
    2 / 342 (0.58%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Kidney infection
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Necrotising fasciitis
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tooth infection
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract candidiasis
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    1 / 359 (0.28%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 365 (0.27%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    0 / 365 (0.00%)
    0 / 342 (0.00%)
    0 / 359 (0.00%)
    1 / 361 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypervolaemia
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    0 / 365 (0.00%)
    1 / 342 (0.29%)
    0 / 359 (0.00%)
    0 / 361 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    Arm A: Faricimab Q4W (Part 1) Arm B: Aflibercept Q4W to Faricimab PTI (Part 2) Arm A: Faricimab Q4W to Faricimab PTI (Part 2) Arm B: Aflibercept Q4W (Part 1)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    67 / 365 (18.36%)
    118 / 342 (34.50%)
    109 / 359 (30.36%)
    66 / 361 (18.28%)
    Investigations
    Intraocular pressure increased
    Additional description: AEs occurred in the study eye
         subjects affected / exposed
    9 / 365 (2.47%)
    15 / 342 (4.39%)
    16 / 359 (4.46%)
    12 / 361 (3.32%)
         occurrences all number
    11
    34
    21
    22
    Vascular disorders
    Hypertension
         subjects affected / exposed
    15 / 365 (4.11%)
    8 / 342 (2.34%)
    12 / 359 (3.34%)
    10 / 361 (2.77%)
         occurrences all number
    15
    8
    13
    10
    Eye disorders
    Conjunctival haemorrhage
    Additional description: AEs occurred in the study eye
         subjects affected / exposed
    10 / 365 (2.74%)
    7 / 342 (2.05%)
    10 / 359 (2.79%)
    14 / 361 (3.88%)
         occurrences all number
    11
    8
    11
    14
    Vitreous detachment
    Additional description: AEs occurred in the study eye
         subjects affected / exposed
    11 / 365 (3.01%)
    14 / 342 (4.09%)
    6 / 359 (1.67%)
    9 / 361 (2.49%)
         occurrences all number
    11
    14
    6
    9
    Epiretinal membrane
    Additional description: AEs occurred in the study eye
         subjects affected / exposed
    3 / 365 (0.82%)
    11 / 342 (3.22%)
    3 / 359 (0.84%)
    2 / 361 (0.55%)
         occurrences all number
    3
    11
    3
    2
    Macular oedema
    Additional description: AEs occurred in the study eye
         subjects affected / exposed
    2 / 365 (0.55%)
    14 / 342 (4.09%)
    7 / 359 (1.95%)
    0 / 361 (0.00%)
         occurrences all number
    2
    16
    12
    0
    Cystoid macular oedema
    Additional description: AEs occurred in the study eye
         subjects affected / exposed
    1 / 365 (0.27%)
    10 / 342 (2.92%)
    11 / 359 (3.06%)
    3 / 361 (0.83%)
         occurrences all number
    1
    10
    15
    3
    Cataract
    Additional description: AEs occurred in the study eye
         subjects affected / exposed
    3 / 365 (0.82%)
    14 / 342 (4.09%)
    14 / 359 (3.90%)
    7 / 361 (1.94%)
         occurrences all number
    3
    14
    14
    7
    Infections and infestations
    COVID-19
         subjects affected / exposed
    14 / 365 (3.84%)
    46 / 342 (13.45%)
    42 / 359 (11.70%)
    12 / 361 (3.32%)
         occurrences all number
    14
    46
    42
    12
    Nasopharyngitis
         subjects affected / exposed
    5 / 365 (1.37%)
    16 / 342 (4.68%)
    10 / 359 (2.79%)
    7 / 361 (1.94%)
         occurrences all number
    5
    16
    10
    7

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Nov 2020
    Protocol Version 2, the summary of major changes from Version 1 were as follows: -Due to extenuating circumstances, such as the Coronavirus Disease 2019 (COVID-19) pandemic, patients may not have had the ability to complete certain trial activities, therefore, in order to ensure adequate power for the primary endpoint, the sample size was increased to mitigate the loss of patients, loss of data, and the potential impact of protocol deviations affecting efficacy analyses.; -Clarified that missed mandatory pharmacokinetic (PK), pharmacodynamic (PD), or anti-drug antibody (ADA) samples be obtained at the next scheduled visit the patient attended.; -Clarified administration guidelines of the National Eye Institute 25-Item Visual Functioning Questionnaire (NEI VFQ-25) to include interviews over the telephone.; -Corrected the description of the BCVA stratification factor’s text in the protocol (programming in IxRS was initially correct so no changes in programming were necessary).

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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