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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
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

GR41986

ISRCTN number

US NCT number

NCT04740931

WHO universal trial number (UTN)

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

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

12 Jul 2023

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

12 Jul 2023

Was the trial ended prematurely?

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

Independent data monitoring committee (IDMC) involvement?

Yes

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

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

320

From 65 to 84 years

377

85 years and over

Subject disposition

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Recruitment details

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 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

Are arms mutually exclusive

Yes

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 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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Reporting group title

Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)

Reporting group description

Reporting group title

Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)

Reporting group description

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 set title

Arm A: Faricimab Q4W (Part 1)

Subject analysis set type

Intention-to-treat

Subject analysis set description

Subject analysis set title

Arm B: Aflibercept Q4W (Part 1)

Subject analysis set type

Intention-to-treat

Subject analysis set description

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

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

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

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

Subject analysis set title

Arm B: Aflibercept Q4W (Part 1)

Subject analysis set type

Safety analysis

Subject analysis set description

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.

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

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

Units: Years

arithmetic mean (standard deviation)

16.9 ( )

17.3 ( )

( )

5.0 ( )

4.0 ( )

( )

Units: Participants

Female

Male

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

Units: Subjects

Hispanic or Latino

Not Hispanic or Latino

Unknown or Not Reported

Units: Subjects

Rest of World

USA and Canada

Asia

Units: Subjects

Left Eye

Right Eye

Units: Subjects

≤34 Letters (20/200 or Worse)

>34 Letters to <55 Letters

≥55 Letters (20/80 or Better)

Units: ETDRS Letters

arithmetic mean (standard deviation)

16.9 ( )

17.3 ( )

( )

5.0 ( )

4.0 ( )

( )

End points

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Reporting group title

Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)

Reporting group description

Reporting group title

Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)

Reporting group description

Subject analysis set title

Arm A: Faricimab Q4W (Part 1)

Subject analysis set type

Intention-to-treat

Subject analysis set description

Subject analysis set title

Arm B: Aflibercept Q4W (Part 1)

Subject analysis set type

Intention-to-treat

Subject analysis set description

Subject analysis set title

Arm A: Faricimab Q4W to Faricimab PTI (Part 2)

Subject analysis set type

Intention-to-treat

Subject analysis set description

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

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

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

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

Subject analysis set title

Arm B: Aflibercept Q4W (Part 1)

Subject analysis set type

Safety analysis

Subject analysis set description

Subject analysis set title

All Faricimab Participants

Subject analysis set type

Safety analysis

Subject analysis set description

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)

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.

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: 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

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 ≥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)

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: 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 ≥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 ≥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: 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 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: 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)

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

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

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

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

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

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

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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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 name

MedDRA

Dictionary version

26.0

Reporting group title

Arm A: Faricimab Q4W (Part 1)

Reporting group description

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

Reporting group title

Arm B: Aflibercept Q4W (Part 1)

Reporting group description

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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Were there any global substantial amendments to the protocol? Yes

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).

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

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

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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