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    Clinical Trial Results:
    A Randomized, Double-masked, Phase 3 Study of ABP 938 Efficacy and Safety Compared to Aflibercept (Eylea(R)) in Subjects with Neovascular Age-related Macular Degeneration

    Summary
    EudraCT number
    		 2019-002503-17
    Trial protocol
    		 DE   LV   EE   SK   ES   CZ   LT   PL   IT  
    Global end of trial date
    30 Jan 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Dec 2023
    First version publication date
    29 Dec 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    20170542
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04270747
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Amgen Inc.
    Sponsor organisation address
    One Amgen Center Drive, Thousand Oaks, CA, United States,
    Public contact
    Study Director, Amgen Inc., +1 8665726436, medinfo@amgen.com
    Scientific contact
    Study Director, Amgen Inc., +1 8665726436, medinfo@amgen.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 Jan 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jan 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the study was to assess the efficacy of ABP 938 compared to aflibercept.
    Protection of trial subjects
    This study was conducted in accordance with International Council for Harmonisation Good Clinical Practice regulations/guidelines.
    Background therapy
    		 -
    Evidence for comparator
    		 Eylea (aflibercept) belongs to the pharmacologic class of vascular endothelial growth factor (VEGF) inhibitors. In the United States and the European Union, Eylea (aflibercept) is approved for intravitreal (IVT) administration in the treatment of neovascular (wet) age-related macular degeneration.
    Actual start date of recruitment
    22 Jun 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Korea, Republic of: 37
    Country: Number of subjects enrolled
    Japan: 25
    Country: Number of subjects enrolled
    Hong Kong: 12
    Country: Number of subjects enrolled
    Hungary: 90
    Country: Number of subjects enrolled
    Poland: 55
    Country: Number of subjects enrolled
    Germany: 30
    Country: Number of subjects enrolled
    Italy: 26
    Country: Number of subjects enrolled
    Czechia: 24
    Country: Number of subjects enrolled
    Israel: 18
    Country: Number of subjects enrolled
    Spain: 18
    Country: Number of subjects enrolled
    Slovakia: 14
    Country: Number of subjects enrolled
    Estonia: 12
    Country: Number of subjects enrolled
    Latvia: 11
    Country: Number of subjects enrolled
    Lithuania: 5
    Country: Number of subjects enrolled
    United States: 194
    Country: Number of subjects enrolled
    Canada: 5
    Worldwide total number of subjects
    576
    EEA total number of subjects
    285
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    49
    From 65 to 84 years
    449
    85 years and over
    78

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at 102 centers in Canada, Czech Republic, Estonia, Germany, Hong Kong, Hungary, Israel, Italy, Japan, South Korea, Latvia, Lithuania, Poland, Slovakia, Spain, and the United States between 22 June 2020 and 30 January 2023.

    Pre-assignment
    Screening details
    		 Both eyes were assessed at the screening visit for eligibility, and only 1 eye was selected from each participant as the study eye. If both eyes met the eligibility criteria, the study eye was the one with the worse best corrected visual acuity (BCVA).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ABP 938
    Arm description
    		 Participants were randomized to receive 2 mg (0.05 mL) of ABP 938 by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) and remained on ABP 938 dosing every 8 weeks from Week 16 until Week 48.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABP 938
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Administered by IVT injection.

    Arm title
    		 Aflibercept
    Arm description
    		 Participants were randomized to receive 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) and were re-randomized to receive aflibercept or ABP 938 dosing every 8 weeks from Week 16 until Week 48.
    Arm type
    		 Active comparator

    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
    Administered by IVT injection.

    Number of subjects in period 1
    		ABP 938 Aflibercept
    Started
    288
    288
    Completed Through Week 16
    273
    270
    Received ABP 938 Post Week 16
    273
    133 [1]
    Received Aflibercept Post Week 16
    0 [2]
    136 [3]
    Completed
    251
    248
    Not completed
    37
    40
         Adverse event, serious fatal
    2
    4
         Physician decision
    4
    3
         Adverse event, non-fatal
    8
    8
         Miscellaneous
    2
    2
         Protocol Specified Criteria
    6
    7
         Requirement for Alternative Dosing Schedule
    2
    1
         Lost to follow-up
    4
    1
         Requirement for Alternative Therapy
    1
    -
         Consent Withdrawn
    7
    12
         Protocol deviation
    1
    2
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Participants included in ABP 938 or aflibercept milestone post Week 16.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Milestone N/A for ABP 938 arm.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Participants included in ABP 938 or aflibercept milestone post Week 16.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ABP 938
    Reporting group description
    		 Participants were randomized to receive 2 mg (0.05 mL) of ABP 938 by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) and remained on ABP 938 dosing every 8 weeks from Week 16 until Week 48.

    Reporting group title
    Aflibercept
    Reporting group description
    		 Participants were randomized to receive 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) and were re-randomized to receive aflibercept or ABP 938 dosing every 8 weeks from Week 16 until Week 48.

    Reporting group values
    		 ABP 938 Aflibercept Total
    Number of subjects
    		 288 288 576
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 76.0 ( 7.93 ) 76.0 ( 7.95 ) -
    Sex: Female, Male
    Units:
        Female
    		 151 171 322
        Male
    		 137 117 254
    Race/Ethnicity, Customized
    Units: Subjects
        Asian
    		 36 39 75
        Black or African American
    		 1 1 2
        Multiple
    		 1 0 1
        White
    		 250 248 498
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 6 13 19
        Not Hispanic or Latino
    		 281 275 556
        Unknown or Not Reported
    		 1 0 1

    End points

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    End points reporting groups
    Reporting group title
    ABP 938
    Reporting group description
    		 Participants were randomized to receive 2 mg (0.05 mL) of ABP 938 by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) and remained on ABP 938 dosing every 8 weeks from Week 16 until Week 48.

    Reporting group title
    Aflibercept
    Reporting group description
    		 Participants were randomized to receive 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) and were re-randomized to receive aflibercept or ABP 938 dosing every 8 weeks from Week 16 until Week 48.

    Subject analysis set title
    ABP 938 / ABP 938
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants who were initially randomized to receive 2 mg (0.05 mL) of ABP 938 by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) and remained on ABP 938 dosing every 8 weeks from Week 16 until Week 48.

    Subject analysis set title
    Aflibercept / ABP 938
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants who were initially randomized to receive 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) were re-randomized to receive 2 mg (0.05 mL) of ABP 938 by IVT injection in the study eye every 8 weeks from Week 16 until Week 48.

    Subject analysis set title
    Aflibercept / Aflibercept
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants who were initially randomized to receive 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) and were re-randomized to receive aflibercept dosing every 8 weeks from Week 16 until Week 48.

    Subject analysis set title
    Through Week 16: ABP 938
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants were treated with 2 mg (0.05 mL) of ABP 938 by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8).

    Subject analysis set title
    Through Week 16: Aflibercept
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants were treated with 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8).

    Subject analysis set title
    Post Week 16: ABP 938 / ABP 938
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants who were initially treated with ABP 938 and remained on treatment with 2 mg (0.05 mL) of ABP 938 by IVT injection in the study eye every 8 weeks from Week 16 until Week 48.

    Subject analysis set title
    Post Week 16: Aflibercept / ABP 938
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants who were initially treated with aflibercept and were re-randomized and treated with 2 mg (0.05 mL) of ABP-938 by IVT injection in the study eye every 8 weeks from Week 16 until Week 48.

    Subject analysis set title
    Post Week 16: Aflibercept / Aflibercept
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants who were initially treated with aflibercept and were re-randomized and treated with 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 8 weeks from Week 16 until Week 48.

    Primary: Mean Change from Baseline in BCVA at Week 8

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    End point title
    		 Mean Change from Baseline in BCVA at Week 8
    End point description
    BCVA score was assessed based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart by the study eye at 4 meters. ETDRS letters score could range from 0 to 100 letters at each assessment. A positive change from Baseline in ETDRS letter score indicated an improvement in visual acuity in the study eye. Change from Baseline calculated as observed post-baseline value - Baseline value. Full Analysis Set: Consisted of all randomized participants, with treatment as the randomized treatment regardless of actual treatment received. Participants were included in the treatment group in which they were initially randomized. Analysis included participants with available data at Baseline and Week 8.
    End point type
    Primary
    End point timeframe
    Baseline and Week 8
    End point values
    		 ABP 938 Aflibercept
    Number of subjects analysed
    279
    281
    Units: Letters
        arithmetic mean (standard deviation)
    6.4 ( 8.18 )
    6.5 ( 8.97 )
    Statistical analysis title
    		 ABP 938 versus (vs.) Aflibercept
    Statistical analysis description
    Difference in mean change from Baseline at Week 8. Estimated using analysis of covariance (ANCOVA) model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.
    Comparison groups
    ABP 938 v Aflibercept
    Number of subjects included in analysis
    560
    Analysis specification
    Pre-specified
    Analysis type
    		 [1]
    Method
    Parameter type
    		 Difference between means
    Point estimate
    0.1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 1.3
    Notes
    [1] - A pre-specified similarity margin of (-3, 3) ETDRS letters was used to demonstrate clinical similarity for the mean change from Baseline in BCVA at Week 8.

    Secondary: Percentage of Participants who Maintained Vision at Week 52

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    End point title
    		 Percentage of Participants who Maintained Vision at Week 52
    End point description
    A participant was classified as maintaining vision if he/she lost fewer than 15 letters in ETDRS letter score, assessed in the study eye, compared to Baseline. Full Analysis Set (Re-randomized): Consisted of all re-randomized participants, with treatment as the randomized treatment regardless of actual treatment received. Participants were included in the treatment group in which they were re-randomized. Analysis included participants with available data at Baseline and Week 52.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 ABP 938 / ABP 938 Aflibercept / ABP 938 Aflibercept / Aflibercept
    Number of subjects analysed
    251
    123
    125
    Units: Percentage of Participants
        number (confidence interval 95%)
    95.6 (93.1 to 98.2)
    95.9 (92.5 to 99.4)
    97.6 (94.9 to 100.0)
    Statistical analysis title
    		 ABP 938 / ABP 938 vs. Aflibercept / Aflibercept
    Statistical analysis description
    Risk difference in percentage of participants who maintained vision at Week 52. Estimated using the stratified Newcombe confidence limits (with Mantel-Haenszel weights) adjusting for stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA < 64 letters, BCVA ≥ 64 letters).
    Comparison groups
    ABP 938 / ABP 938 v Aflibercept / Aflibercept
    Number of subjects included in analysis
    376
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -2.1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -5.2
         upper limit
    		 2.2
    Statistical analysis title
    		 Aflibercept/ABP 938 vs. Aflibercept/Aflibercept
    Statistical analysis description
    Risk difference in percentage of participants who maintained vision at Week 52. Estimated using the stratified Newcombe confidence limits (with Mantel-Haenszel weights) adjusting for stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA < 64 letters, BCVA ≥ 64 letters).
    Comparison groups
    Aflibercept / ABP 938 v Aflibercept / Aflibercept
    Number of subjects included in analysis
    248
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -1.7
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -6.2
         upper limit
    		 2.8

    Secondary: Mean Change from Baseline in BCVA

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    End point title
    		 Mean Change from Baseline in BCVA
    End point description
    BCVA score was assessed based on the number of letters read correctly on the ETDRS chart by the study eye at 4 meters. ETDRS letters score could range from 0 to 100 letters at each assessment. A positive change from Baseline in ETDRS letter score indicated an improvement in visual acuity in the study eye. Change from Baseline calculated as observed post-baseline value - Baseline value. Full Analysis Set (Re-randomized): Consisted of all randomized participants, with treatment as the re-randomized treatment regardless of actual treatment received. Participants were included in the treatment group in which they were re-randomized. Analysis included participants with available data at Baseline and at each timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 8, 16, 24, 32, 40, 48, and 52
    End point values
    		 ABP 938 / ABP 938 Aflibercept / ABP 938 Aflibercept / Aflibercept
    Number of subjects analysed
    273
    134
    136
    Units: Letters
    arithmetic mean (standard deviation)
        Week 4 (n = 272, 136, 131)
    5.0 ( 6.57 )
    3.8 ( 8.19 )
    5.4 ( 8.35 )
        Week 8 (n = 270, 134, 133)
    6.5 ( 8.10 )
    5.6 ( 8.86 )
    7.6 ( 9.30 )
        Week 16 (n = 273, 136, 134)
    6.8 ( 8.69 )
    7.1 ( 9.32 )
    7.5 ( 9.31 )
        Week 24 (n = 267, 136, 130)
    7.2 ( 9.63 )
    7.0 ( 10.12 )
    7.1 ( 9.30 )
        Week 32 (n = 263, 132, 131)
    7.1 ( 11.00 )
    6.6 ( 11.11 )
    8.7 ( 9.21 )
        Week 40 (n = 258, 130, 125)
    7.3 ( 11.00 )
    7.9 ( 10.08 )
    8.1 ( 11.00 )
        Week 48 (n = 251, 126, 123)
    7.2 ( 11.51 )
    8.1 ( 10.74 )
    8.7 ( 10.84 )
        Week 52 (n = 251, 125, 123)
    7.6 ( 11.60 )
    8.0 ( 11.14 )
    9.4 ( 10.18 )
    Statistical analysis title
    		 ABP 938 / ABP 938 vs. Aflibercept / Aflibercept
    Statistical analysis description
    Difference in mean change from Baseline at Week 4. Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.
    Comparison groups
    ABP 938 / ABP 938 v Aflibercept / Aflibercept
    Number of subjects included in analysis
    409
    Analysis specification
    Pre-specified
    Analysis type
    		 [2]
    Method
    Parameter type
    		 Difference between means
    Point estimate
    -0.1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 1.2
    Notes
    [2] - Participants in this analysis: 408.
    Statistical analysis title
    		 ABP 938 / ABP 938 vs. Aflibercept / Aflibercept
    Statistical analysis description
    Difference in mean change from Baseline at Week 8. Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.
    Comparison groups
    ABP 938 / ABP 938 v Aflibercept / Aflibercept
    Number of subjects included in analysis
    409
    Analysis specification
    Pre-specified
    Analysis type
    		 [3]
    Method
    Parameter type
    		 Difference between means
    Point estimate
    -0.8
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.3
         upper limit
    		 0.7
    Notes
    [3] - Participants in this analysis: 404.
    Statistical analysis title
    		 ABP 938 / ABP 938 vs. Aflibercept / Aflibercept
    Statistical analysis description
    Difference in mean change from Baseline at Week 16. Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.
    Comparison groups
    ABP 938 / ABP 938 v Aflibercept / Aflibercept
    Number of subjects included in analysis
    409
    Analysis specification
    Pre-specified
    Analysis type
    		 [4]
    Method
    Parameter type
    		 Difference between means
    Point estimate
    -0.3
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.9
         upper limit
    		 1.2
    Notes
    [4] - Participants in this analysis: 409.
    Statistical analysis title
    		 ABP 938 / ABP 938 vs. Aflibercept / Aflibercept
    Statistical analysis description
    Difference in mean change from Baseline at Week 24. Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.
    Comparison groups
    ABP 938 / ABP 938 v Aflibercept / Aflibercept
    Number of subjects included in analysis
    409
    Analysis specification
    Pre-specified
    Analysis type
    		 [5]
    Method
    Parameter type
    		 Difference between means
    Point estimate
    0.4
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 2.1
    Notes
    [5] - Participants in this analysis: 403.
    Statistical analysis title
    		 ABP 938 / ABP 938 vs. Aflibercept / Aflibercept
    Statistical analysis description
    Difference in mean change from Baseline at Week 32. Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.
    Comparison groups
    ABP 938 / ABP 938 v Aflibercept / Aflibercept
    Number of subjects included in analysis
    409
    Analysis specification
    Pre-specified
    Analysis type
    		 [6]
    Method
    Parameter type
    		 Difference between means
    Point estimate
    -1.3
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -3.1
         upper limit
    		 0.5
    Notes
    [6] - Participants in this analysis: 395.
    Statistical analysis title
    		 ABP 938 / ABP 938 vs. Aflibercept / Aflibercept
    Statistical analysis description
    Difference in mean change from Baseline at Week 40. Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.
    Comparison groups
    ABP 938 / ABP 938 v Aflibercept / Aflibercept
    Number of subjects included in analysis
    409
    Analysis specification
    Pre-specified
    Analysis type
    		 [7]
    Method
    Parameter type
    		 Difference between means
    Point estimate
    -0.5
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.3
         upper limit
    		 1.4
    Notes
    [7] - Participants in this analysis: 388.
    Statistical analysis title
    		 ABP 938 / ABP 938 vs. Aflibercept / Aflibercept
    Statistical analysis description
    Difference in mean change from Baseline at Week 48. Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.
    Comparison groups
    ABP 938 / ABP 938 v Aflibercept / Aflibercept
    Number of subjects included in analysis
    409
    Analysis specification
    Pre-specified
    Analysis type
    		 [8]
    Method
    Parameter type
    		 Difference between means
    Point estimate
    -1.2
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -3.2
         upper limit
    		 0.8
    Notes
    [8] - Participants in this analysis: 377.
    Statistical analysis title
    		 ABP 938 / ABP 938 vs. Aflibercept / Aflibercept
    Statistical analysis description
    Difference in mean change from Baseline at Week 52. Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.
    Comparison groups
    ABP 938 / ABP 938 v Aflibercept / Aflibercept
    Number of subjects included in analysis
    409
    Analysis specification
    Pre-specified
    Analysis type
    		 [9]
    Method
    Parameter type
    		 Difference between means
    Point estimate
    -1.5
    Confidence interval
         level
    		 2%
         sides
    2-sided
         lower limit
    		 -3.4
         upper limit
    		 0.5
    Notes
    [9] - Participants in this analysis: 376.
    Statistical analysis title
    		 Aflibercept/ABP 938 vs. Aflibercept/Aflibercept
    Statistical analysis description
    Difference in mean change from Baseline at Week 32. Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.
    Comparison groups
    Aflibercept / ABP 938 v Aflibercept / Aflibercept
    Number of subjects included in analysis
    270
    Analysis specification
    Pre-specified
    Analysis type
    		 [10]
    Method
    Parameter type
    		 Difference between means
    Point estimate
    -1.9
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -4
         upper limit
    		 0.2
    Notes
    [10] - Participants in this analysis: 263.
    Statistical analysis title
    		 Aflibercept/ABP 938 vs. Aflibercept/Aflibercept
    Statistical analysis description
    Difference in mean change from Baseline at Week 24. Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.
    Comparison groups
    Aflibercept / ABP 938 v Aflibercept / Aflibercept
    Number of subjects included in analysis
    270
    Analysis specification
    Pre-specified
    Analysis type
    		 [11]
    Method
    Parameter type
    		 Difference between means
    Point estimate
    0
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.9
         upper limit
    		 2
    Notes
    [11] - Participants in this analysis: 266.
    Statistical analysis title
    		 Aflibercept/ABP 938 vs. Aflibercept/Aflibercept
    Statistical analysis description
    Difference in mean change from Baseline at Week 4. Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.
    Comparison groups
    Aflibercept / ABP 938 v Aflibercept / Aflibercept
    Number of subjects included in analysis
    270
    Analysis specification
    Pre-specified
    Analysis type
    		 [12]
    Method
    Parameter type
    		 Difference between means
    Point estimate
    -1.5
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -3
         upper limit
    		 0
    Notes
    [12] - Participants in this analysis: 267.
    Statistical analysis title
    		 Aflibercept/ABP 938 vs. Aflibercept/Aflibercept
    Statistical analysis description
    Difference in mean change from Baseline at Week 8. Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.
    Comparison groups
    Aflibercept / ABP 938 v Aflibercept / Aflibercept
    Number of subjects included in analysis
    270
    Analysis specification
    Pre-specified
    Analysis type
    		 [13]
    Method
    Parameter type
    		 Difference between means
    Point estimate
    -1.9
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -3.6
         upper limit
    		 -0.2
    Notes
    [13] - Participants in this analysis: 267.
    Statistical analysis title
    		 Aflibercept/ABP 938 vs. Aflibercept/Aflibercept
    Statistical analysis description
    Difference in mean change from Baseline at Week 16. Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.
    Comparison groups
    Aflibercept / ABP 938 v Aflibercept / Aflibercept
    Number of subjects included in analysis
    270
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference between means
    Point estimate
    -0.3
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.1
         upper limit
    		 1.5
    Statistical analysis title
    		 Aflibercept/ABP 938 vs. Aflibercept/Aflibercept
    Statistical analysis description
    Difference in mean change from Baseline at Week 40. Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.
    Comparison groups
    Aflibercept / ABP 938 v Aflibercept / Aflibercept
    Number of subjects included in analysis
    270
    Analysis specification
    Pre-specified
    Analysis type
    		 [14]
    Method
    Parameter type
    		 Difference between means
    Point estimate
    0
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.2
         upper limit
    		 2.2
    Notes
    [14] - Participants in this analysis: 255.
    Statistical analysis title
    		 Aflibercept/ABP 938 vs. Aflibercept/Aflibercept
    Statistical analysis description
    Difference in mean change from Baseline at Week 48. Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.
    Comparison groups
    Aflibercept / ABP 938 v Aflibercept / Aflibercept
    Number of subjects included in analysis
    270
    Analysis specification
    Pre-specified
    Analysis type
    		 [15]
    Method
    Parameter type
    		 Difference between means
    Point estimate
    -0.6
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.9
         upper limit
    		 1.7
    Notes
    [15] - Participants in this analysis: 249.
    Statistical analysis title
    		 Aflibercept/ABP 938 vs. Aflibercept/Aflibercept
    Statistical analysis description
    Difference in mean change from Baseline at Week 52. Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.
    Comparison groups
    Aflibercept / ABP 938 v Aflibercept / Aflibercept
    Number of subjects included in analysis
    270
    Analysis specification
    Pre-specified
    Analysis type
    		 [16]
    Method
    Parameter type
    		 Difference between means
    Point estimate
    -1.2
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -3.5
         upper limit
    		 1.1
    Notes
    [16] - Participants in this analysis: 248.

    Secondary: Percentage of Participants who Gained at Least 10 Letters of Vision at Week 8

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    End point title
    		 Percentage of Participants who Gained at Least 10 Letters of Vision at Week 8
    End point description
    Percentage of participants who gained at least 10 letters of vision was assessed based on the number of letters read correctly on the ETDRS chart by the study eye at 4 meters. ETDRS letters score could range from 0 to 100 letters at each assessment. Full Analysis Set: Consisted of all randomized participants, with treatment as the randomized treatment regardless of actual treatment received. Participants were included in the treatment group in which they were initially randomized. Analysis included participants with available data at Baseline and Week 8.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 ABP 938 Aflibercept
    Number of subjects analysed
    279
    281
    Units: Percentage of participants
        number (confidence interval 95%)
    29.4 (24.1 to 34.7)
    32.7 (27.3 to 38.2)
    Statistical analysis title
    		 ABP 938 vs. Aflibercept
    Statistical analysis description
    Risk difference in percentage of participants who gained at least 10 letters of vision at Week 8. Estimated using the stratified Newcombe confidence limits (with Mantel-Haenszel weights) adjusting for stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA < 64 letters, BCVA ≥ 64 letters).
    Comparison groups
    ABP 938 v Aflibercept
    Number of subjects included in analysis
    560
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -3.4
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -9.8
         upper limit
    		 3.1

    Secondary: Percentage of Participants who Gained at Least 15 Letters of Vision at Week 52

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    End point title
    		 Percentage of Participants who Gained at Least 15 Letters of Vision at Week 52
    End point description
    Percentage of participants who gained at least 15 letters of vision was assessed based on the number of letters read correctly on the ETDRS chart by the study eye at 4 meters. ETDRS letters score could range from 0 to 100 letters at each assessment. Full Analysis Set (Re-randomized): Consisted of all re-randomized participants, with treatment as the randomized treatment regardless of actual treatment received. Participants were included in the treatment group in which they were re-randomized. Analysis included participants with available data at Baseline and Week 52.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 ABP 938 / ABP 938 Aflibercept / ABP 938 Aflibercept / Aflibercept
    Number of subjects analysed
    251
    123
    125
    Units: Percentage of participants
        number (confidence interval 95%)
    24.3 (19.0 to 29.6)
    24.4 (16.8 to 32.0)
    29.6 (21.6 to 37.6)
    Statistical analysis title
    		 Aflibercept/ABP 938 vs. Aflibercept/Aflibercept
    Statistical analysis description
    Risk difference in percentage of participants who gained at least 15 letters of vision at Week 52. Estimated using the stratified Newcombe confidence limits (with Mantel-Haenszel weights) adjusting for stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA < 64 letters, BCVA ≥ 64 letters).
    Comparison groups
    Aflibercept / ABP 938 v Aflibercept / Aflibercept
    Number of subjects included in analysis
    248
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -5.2
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -14.4
         upper limit
    		 4.2
    Statistical analysis title
    		 ABP 938 / ABP 938 vs. Aflibercept / Aflibercept
    Statistical analysis description
    Risk difference in percentage of participants who gained at least 15 letters of vision at Week 52. Estimated using the stratified Newcombe confidence limits (with Mantel-Haenszel weights) adjusting for stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA < 64 letters, BCVA ≥ 64 letters).
    Comparison groups
    ABP 938 / ABP 938 v Aflibercept / Aflibercept
    Number of subjects included in analysis
    376
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -5.3
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -13.6
         upper limit
    		 2.5

    Secondary: Mean Change from Baseline in Choroidal Neovascularization (CNV) Area Size

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    End point title
    		 Mean Change from Baseline in Choroidal Neovascularization (CNV) Area Size
    End point description
    CNV area size was measured by fluorescein angiography. Change from Baseline calculated as observed post-baseline value - Baseline value. Full Analysis Set (Re-randomized): Consisted of all randomized participants, with treatment as the re-randomized treatment regardless of actual treatment received. Participants were included in the treatment group in which they were re-randomized. Analysis included participants with available data at Baseline and at each timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 8, 16, 24, and 52
    End point values
    		 ABP 938 / ABP 938 Aflibercept / ABP 938 Aflibercept / Aflibercept
    Number of subjects analysed
    255
    130
    127
    Units: mm^2
    arithmetic mean (standard deviation)
        Week 8 (n = 255, 127, 130)
    -4.962 ( 5.1604 )
    -5.169 ( 4.6943 )
    -5.479 ( 5.1023 )
        Week 16 (n = 245, 121, 125)
    -4.089 ( 5.3668 )
    -4.751 ( 4.8814 )
    -5.174 ( 5.2280 )
        Week 24 (n = 242, 119, 118)
    -4.323 ( 5.5972 )
    -5.121 ( 5.2776 )
    -5.308 ( 5.6238 )
        Week 52 (n = 234, 119, 114)
    -6.276 ( 6.2690 )
    -6.434 ( 5.2445 )
    -7.280 ( 5.8262 )
    Statistical analysis title
    		 ABP 938 / ABP 938 vs. Aflibercept / Aflibercept
    Statistical analysis description
    Difference in mean change from Baseline at Week 8. Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA < 64 letters, BCVA ≥ 64 letters) as covariates.
    Comparison groups
    ABP 938 / ABP 938 v Aflibercept / Aflibercept
    Number of subjects included in analysis
    382
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference between means
    Point estimate
    -0.048
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.734
         upper limit
    		 0.638
    Statistical analysis title
    		 ABP 938 / ABP 938 vs. Aflibercept / Aflibercept
    Statistical analysis description
    Difference in mean change from Baseline at Week 16. Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA < 64 letters, BCVA ≥ 64 letters) as covariates.
    Comparison groups
    ABP 938 / ABP 938 v Aflibercept / Aflibercept
    Number of subjects included in analysis
    382
    Analysis specification
    Pre-specified
    Analysis type
    		 [17]
    Method
    Parameter type
    		 Difference between means
    Point estimate
    0.431
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.367
         upper limit
    		 1.229
    Notes
    [17] - Participants in this analysis: 366.
    Statistical analysis title
    		 ABP 938 / ABP 938 vs. Aflibercept / Aflibercept
    Statistical analysis description
    Difference in mean change from Baseline at Week 24. Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA < 64 letters, BCVA ≥ 64 letters) as covariates.
    Comparison groups
    ABP 938 / ABP 938 v Aflibercept / Aflibercept
    Number of subjects included in analysis
    382
    Analysis specification
    Pre-specified
    Analysis type
    		 [18]
    Method
    Parameter type
    		 Difference between means
    Point estimate
    0.197
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.625
         upper limit
    		 1.019
    Notes
    [18] - Participants in this analysis: 361.
    Statistical analysis title
    		 Aflibercept/ABP 938 vs. Aflibercept/Aflibercept
    Statistical analysis description
    Difference in mean change from Baseline at Week 52. Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA < 64 letters, BCVA ≥ 64 letters) as covariates.
    Comparison groups
    Aflibercept / ABP 938 v Aflibercept / Aflibercept
    Number of subjects included in analysis
    257
    Analysis specification
    Pre-specified
    Analysis type
    		 [19]
    Method
    Parameter type
    		 Difference between means
    Point estimate
    0.647
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.186
         upper limit
    		 1.479
    Notes
    [19] - Participants in this analysis: 233.
    Statistical analysis title
    		 Aflibercept/ABP 938 vs. Aflibercept/Aflibercept
    Statistical analysis description
    Difference in mean change from Baseline at Week 8. Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA < 64 letters, BCVA ≥ 64 letters) as covariates.
    Comparison groups
    Aflibercept / ABP 938 v Aflibercept / Aflibercept
    Number of subjects included in analysis
    257
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference between means
    Point estimate
    0.105
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.682
         upper limit
    		 0.891
    Statistical analysis title
    		 Aflibercept/ABP 938 vs. Aflibercept/Aflibercept
    Statistical analysis description
    Difference in mean change from Baseline at Week 16. Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA < 64 letters, BCVA ≥ 64 letters) as covariates.
    Comparison groups
    Aflibercept / ABP 938 v Aflibercept / Aflibercept
    Number of subjects included in analysis
    257
    Analysis specification
    Pre-specified
    Analysis type
    		 [20]
    Method
    Parameter type
    		 Difference between means
    Point estimate
    0.245
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.667
         upper limit
    		 1.158
    Notes
    [20] - Participants in this analysis: 246.
    Statistical analysis title
    		 Aflibercept/ABP 938 vs. Aflibercept/Aflibercept
    Statistical analysis description
    Difference in mean change from Baseline at Week 24. Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA < 64 letters, BCVA ≥ 64 letters) as covariates.
    Comparison groups
    Aflibercept / ABP 938 v Aflibercept / Aflibercept
    Number of subjects included in analysis
    257
    Analysis specification
    Pre-specified
    Analysis type
    		 [21]
    Method
    Parameter type
    		 Difference between means
    Point estimate
    -0.116
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.065
         upper limit
    		 0.834
    Notes
    [21] - Participants in this analysis: 237.
    Statistical analysis title
    		 ABP 938 / ABP 938 vs. Aflibercept / Aflibercept
    Statistical analysis description
    Difference in mean change from Baseline at Week 52. Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA < 64 letters, BCVA ≥ 64 letters) as covariates.
    Comparison groups
    ABP 938 / ABP 938 v Aflibercept / Aflibercept
    Number of subjects included in analysis
    382
    Analysis specification
    Pre-specified
    Analysis type
    		 [22]
    Method
    Parameter type
    		 Difference between means
    Point estimate
    0.156
    Confidence interval
         level
    		 2%
         sides
    2-sided
         lower limit
    		 -0.561
         upper limit
    		 0.872
    Notes
    [22] - Participants in this analysis: 353.

    Secondary: Mean Change from Baseline in Central Subfield Thickness (CST)

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    End point title
    		 Mean Change from Baseline in Central Subfield Thickness (CST)
    End point description
    CST was defined as the average thickness in the ETDRS central 1 mm diameter subfield (the central subfield) and was measured by spectral domain optical coherence tomography. Change from Baseline calculated as observed post-baseline value - Baseline value. Full Analysis Set (Re-randomized): Consisted of all randomized participants, with treatment as the re-randomized treatment regardless of actual treatment received. Participants were included in the treatment group in which they were re-randomized. Analysis included participants with available data at Baseline and at each timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 8, 16, 24, 32, 40, 48, and 52
    End point values
    		 ABP 938 / ABP 938 Aflibercept / ABP 938 Aflibercept / Aflibercept
    Number of subjects analysed
    273
    134
    136
    Units: μm
    arithmetic mean (standard deviation)
        Week 4 (n = 270, 136, 131)
    -136.5 ( 108.91 )
    -149.7 ( 107.01 )
    -143.1 ( 107.32 )
        Week 8 (n = 269, 134, 132)
    -145.9 ( 106.24 )
    -167.4 ( 118.52 )
    -146.3 ( 110.39 )
        Week 16 (n = 273, 135, 134)
    -125.2 ( 124.81 )
    -143.2 ( 121.93 )
    -127.3 ( 103.35 )
        Week 24 (n = 265, 133, 128)
    -130.8 ( 125.63 )
    -151.2 ( 118.21 )
    -131.7 ( 102.98 )
        Week 32 (n = 262, 132, 131)
    -133.2 ( 122.93 )
    -154.8 ( 114.22 )
    -134.1 ( 116.02 )
        Week 40 (n = 257, 130, 124)
    -132.3 ( 113.25 )
    -155.7 ( 119.95 )
    -135.6 ( 119.07 )
        Week 48 (n = 251, 125, 123)
    -132.3 ( 124.15 )
    -157.8 ( 121.23 )
    -141.1 ( 112.29 )
        Week 52 (n = 250, 125, 123)
    -157.1 ( 114.25 )
    -177.4 ( 122.22 )
    -159.1 ( 108.82 )
    Statistical analysis title
    		 ABP 938 / ABP 938 vs. Aflibercept / Aflibercept
    Statistical analysis description
    Difference in mean change from Baseline at Week 16. Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA < 64 letters, BCVA ≥ 64 letters) as covariates.
    Comparison groups
    ABP 938 / ABP 938 v Aflibercept / Aflibercept
    Number of subjects included in analysis
    409
    Analysis specification
    Pre-specified
    Analysis type
    		 [23]
    Method
    Parameter type
    		 Difference between means
    Point estimate
    1.9
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -12.9
         upper limit
    		 16.6
    Notes
    [23] - Participants in this analysis: 408.
    Statistical analysis title
    		 ABP 938 / ABP 938 vs. Aflibercept / Aflibercept
    Statistical analysis description
    Difference in mean change from Baseline at Week 8. Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA < 64 letters, BCVA ≥ 64 letters) as covariates.
    Comparison groups
    ABP 938 / ABP 938 v Aflibercept / Aflibercept
    Number of subjects included in analysis
    409
    Analysis specification
    Pre-specified
    Analysis type
    		 [24]
    Method
    Parameter type
    		 Difference between means
    Point estimate
    1.3
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -11
         upper limit
    		 13.5
    Notes
    [24] - Participants in this analysis: 403.
    Statistical analysis title
    		 ABP 938 / ABP 938 vs. Aflibercept / Aflibercept
    Statistical analysis description
    Difference in mean change from Baseline at Week 4. Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA < 64 letters, BCVA ≥ 64 letters) as covariates.
    Comparison groups
    ABP 938 / ABP 938 v Aflibercept / Aflibercept
    Number of subjects included in analysis
    409
    Analysis specification
    Pre-specified
    Analysis type
    		 [25]
    Method
    Parameter type
    		 Difference between means
    Point estimate
    6.2
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -5.6
         upper limit
    		 17.9
    Notes
    [25] - Participants in this analysis: 406.
    Statistical analysis title
    		 ABP 938 / ABP 938 vs. Aflibercept / Aflibercept
    Statistical analysis description
    Difference in mean change from Baseline at Week 40. Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA < 64 letters, BCVA ≥ 64 letters) as covariates.
    Comparison groups
    ABP 938 / ABP 938 v Aflibercept / Aflibercept
    Number of subjects included in analysis
    409
    Analysis specification
    Pre-specified
    Analysis type
    		 [26]
    Method
    Parameter type
    		 Difference between means
    Point estimate
    0.2
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -13.7
         upper limit
    		 14.1
    Notes
    [26] - Participants in this analysis: 387.
    Statistical analysis title
    		 ABP 938 / ABP 938 vs. Aflibercept / Aflibercept
    Statistical analysis description
    Difference in mean change from Baseline at Week 32. Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA < 64 letters, BCVA ≥ 64 letters) as covariates.
    Comparison groups
    ABP 938 / ABP 938 v Aflibercept / Aflibercept
    Number of subjects included in analysis
    409
    Analysis specification
    Pre-specified
    Analysis type
    		 [27]
    Method
    Parameter type
    		 Difference between means
    Point estimate
    -1.2
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -15.3
         upper limit
    		 12.9
    Notes
    [27] - Participants in this analysis: 394.
    Statistical analysis title
    		 ABP 938 / ABP 938 vs. Aflibercept / Aflibercept
    Statistical analysis description
    Difference in mean change from Baseline at Week 24. Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA < 64 letters, BCVA ≥ 64 letters) as covariates.
    Comparison groups
    ABP 938 / ABP 938 v Aflibercept / Aflibercept
    Number of subjects included in analysis
    409
    Analysis specification
    Pre-specified
    Analysis type
    		 [28]
    Method
    Parameter type
    		 Difference between means
    Point estimate
    0.1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -14.1
         upper limit
    		 14.4
    Notes
    [28] - Participants in this analysis: 398.
    Statistical analysis title
    		 Aflibercept/ABP 938 vs. Aflibercept/Aflibercept
    Statistical analysis description
    Difference in mean change from Baseline at Week 32. Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA < 64 letters, BCVA ≥ 64 letters) as covariates.
    Comparison groups
    Aflibercept / ABP 938 v Aflibercept / Aflibercept
    Number of subjects included in analysis
    270
    Analysis specification
    Pre-specified
    Analysis type
    		 [29]
    Method
    Parameter type
    		 Difference between means
    Point estimate
    -7
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -23.3
         upper limit
    		 9.3
    Notes
    [29] - Participants in this analysis: 263.
    Statistical analysis title
    		 Aflibercept/ABP 938 vs. Aflibercept/Aflibercept
    Statistical analysis description
    Difference in mean change from Baseline at Week 40. Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA < 64 letters, BCVA ≥ 64 letters) as covariates.
    Comparison groups
    Aflibercept / ABP 938 v Aflibercept / Aflibercept
    Number of subjects included in analysis
    270
    Analysis specification
    Pre-specified
    Analysis type
    		 [30]
    Method
    Parameter type
    		 Difference between means
    Point estimate
    -6.5
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -22.8
         upper limit
    		 9.8
    Notes
    [30] - Participants in this analysis: 254.
    Statistical analysis title
    		 Aflibercept/ABP 938 vs. Aflibercept/Aflibercept
    Statistical analysis description
    Difference in mean change from Baseline at Week 48. Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA < 64 letters, BCVA ≥ 64 letters) as covariates.
    Comparison groups
    Aflibercept / ABP 938 v Aflibercept / Aflibercept
    Number of subjects included in analysis
    270
    Analysis specification
    Pre-specified
    Analysis type
    		 [31]
    Method
    Parameter type
    		 Difference between means
    Point estimate
    -0.5
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -17.3
         upper limit
    		 16.2
    Notes
    [31] - Participants in this analysis: 248.
    Statistical analysis title
    		 Aflibercept/ABP 938 vs. Aflibercept/Aflibercept
    Statistical analysis description
    Difference in mean change from Baseline at Week 24. Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA < 64 letters, BCVA ≥ 64 letters) as covariates.
    Comparison groups
    Aflibercept / ABP 938 v Aflibercept / Aflibercept
    Number of subjects included in analysis
    270
    Analysis specification
    Pre-specified
    Analysis type
    		 [32]
    Method
    Parameter type
    		 Difference between means
    Point estimate
    -6
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -22.6
         upper limit
    		 10.6
    Notes
    [32] - Participants in this analysis: 261.
    Statistical analysis title
    		 Aflibercept/ABP 938 vs. Aflibercept/Aflibercept
    Statistical analysis description
    Difference in mean change from Baseline at Week 16. Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA < 64 letters, BCVA ≥ 64 letters) as covariates.
    Comparison groups
    Aflibercept / ABP 938 v Aflibercept / Aflibercept
    Number of subjects included in analysis
    270
    Analysis specification
    Pre-specified
    Analysis type
    		 [33]
    Method
    Parameter type
    		 Difference between means
    Point estimate
    -3.8
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -20.9
         upper limit
    		 13.3
    Notes
    [33] - Participants in this analysis: 269.
    Statistical analysis title
    		 Aflibercept/ABP 938 vs. Aflibercept/Aflibercept
    Statistical analysis description
    Difference in mean change from Baseline at Week 8. Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA < 64 letters, BCVA ≥ 64 letters) as covariates.
    Comparison groups
    Aflibercept / ABP 938 v Aflibercept / Aflibercept
    Number of subjects included in analysis
    270
    Analysis specification
    Pre-specified
    Analysis type
    		 [34]
    Method
    Parameter type
    		 Difference between means
    Point estimate
    -5.1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -19.3
         upper limit
    		 9.1
    Notes
    [34] - Participants in this analysis: 266.
    Statistical analysis title
    		 Aflibercept/ABP 938 vs. Aflibercept/Aflibercept
    Statistical analysis description
    Difference in mean change from Baseline at Week 4. Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA < 64 letters, BCVA ≥ 64 letters) as covariates.
    Comparison groups
    Aflibercept / ABP 938 v Aflibercept / Aflibercept
    Number of subjects included in analysis
    270
    Analysis specification
    Pre-specified
    Analysis type
    		 [35]
    Method
    Parameter type
    		 Difference between means
    Point estimate
    6.3
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -7.4
         upper limit
    		 20
    Notes
    [35] - Participants in this analysis: 267.
    Statistical analysis title
    		 Aflibercept/ABP 938 vs. Aflibercept/Aflibercept
    Statistical analysis description
    Difference in mean change from Baseline at Week 52. Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA < 64 letters, BCVA ≥ 64 letters) as covariates.
    Comparison groups
    Aflibercept / ABP 938 v Aflibercept / Aflibercept
    Number of subjects included in analysis
    270
    Analysis specification
    Pre-specified
    Analysis type
    		 [36]
    Method
    Parameter type
    		 Difference between means
    Point estimate
    2.3
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -10.5
         upper limit
    		 15
    Notes
    [36] - Participants in this analysis: 248.
    Statistical analysis title
    		 ABP 938 / ABP 938 vs. Aflibercept / Aflibercept
    Statistical analysis description
    Difference in mean change from Baseline at Week 48. Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA < 64 letters, BCVA ≥ 64 letters) as covariates.
    Comparison groups
    ABP 938 / ABP 938 v Aflibercept / Aflibercept
    Number of subjects included in analysis
    409
    Analysis specification
    Pre-specified
    Analysis type
    		 [37]
    Method
    Parameter type
    		 Difference between means
    Point estimate
    7
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -7.4
         upper limit
    		 21.4
    Notes
    [37] - Participants in this analysis: 376.
    Statistical analysis title
    		 ABP 938 / ABP 938 vs. Aflibercept / Aflibercept
    Statistical analysis description
    Difference in mean change from Baseline at Week 52. Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA < 64 letters, BCVA ≥ 64 letters) as covariates.
    Comparison groups
    ABP 938 / ABP 938 v Aflibercept / Aflibercept
    Number of subjects included in analysis
    409
    Analysis specification
    Pre-specified
    Analysis type
    		 [38]
    Method
    Parameter type
    		 Difference between means
    Point estimate
    1.6
    Confidence interval
         level
    		 2%
         sides
    2-sided
         lower limit
    		 -9.3
         upper limit
    		 12.5
    Notes
    [38] - Participants in this analysis: 375.

    Secondary: Number of Participants with Treatment-emergent Adverse Events (TEAEs)

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    End point title
    		 Number of Participants with Treatment-emergent Adverse Events (TEAEs)
    End point description
    An adverse event (AE) is any untoward medical occurrence in a clinical trial participant. TEAEs were defined as those AEs that begin or increase in severity or frequency at or after the time of first treatment to the End of Study visit. Events of interest (EOIs) pre-specified for this study included endophthalmitis, retinal detachment, increase in intraocular pressure, and thromboembolic events. Serious AEs were defined as any untoward medical occurrence that meets at least 1 of the following serious criteria: - Results in death - Life-threatening - Requires inpatient hospitalization or prolongation of existing hospitalization - Results in persistent or significant disability/incapacity - Congenital anomaly/birth defect - Other medically important serious event. Safety Analysis Set: Consisted of all participants who received at least 1 dose of investigational product, with treatment assignment based on actual treatment received.
    End point type
    Secondary
    End point timeframe
    Up to Week 52
    End point values
    		 Through Week 16: ABP 938 Through Week 16: Aflibercept Post Week 16: ABP 938 / ABP 938 Post Week 16: Aflibercept / ABP 938 Post Week 16: Aflibercept / Aflibercept
    Number of subjects analysed
    288
    288
    273 [39]
    133 [40]
    136 [41]
    Units: Participants
        Any TEAEs
    113
    107
    144
    76
    72
        Any EOIs
    6
    3
    9
    8
    2
        Any Serious TEAEs
    6
    9
    22
    14
    11
    Notes
    [39] - Re-randomized and Treated.
    [40] - Re-randomized and Treated.
    [41] - Re-randomized and Treated.
    No statistical analyses for this end point

    Secondary: Number of Participants Developing Binding Antidrug Antibodies (ADAs)

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    End point title
    		 Number of Participants Developing Binding Antidrug Antibodies (ADAs)
    End point description
    Number of participants with positive post-baseline ADA result through Week 16 and post Week 16 with negative or no result at Baseline is reported. Safety Analysis Set (Re-randomized and Treated): Consisted of all participants who received at least 1 dose of investigational product, with treatment assignment based on actual treatment received. Analysis included participants with available data at Baseline and at each timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 52
    End point values
    		 Through Week 16: ABP 938 Through Week 16: Aflibercept Post Week 16: ABP 938 / ABP 938 Post Week 16: Aflibercept / ABP 938 Post Week 16: Aflibercept / Aflibercept
    Number of subjects analysed
    288
    288
    273
    133
    136
    Units: Participants
    1
    4
    4
    3
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Week 52
    Adverse event reporting additional description
    All-cause mortality was collected for all participants enrolled/randomized in the study. AEs were collected for all participants who received at least one dose of study drug through Week 16. AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Through Week 16: ABP 938
    Reporting group description
    		 Participants were treated with 2 mg (0.05 mL) of ABP 938 by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8).

    Reporting group title
    Through Week 16: Aflibercept
    Reporting group description
    		 Participants were treated with 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8).

    Reporting group title
    Post Week 16: Aflibercept / Aflibercept
    Reporting group description
    		 Participants who were initially treated with aflibercept and were re-randomized and treated with 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 8 weeks from Week 16 until Week 48.

    Reporting group title
    Post Week 16: Aflibercept / ABP 938
    Reporting group description
    		 Participants who were initially treated with aflibercept and were re-randomized and treated with 2 mg (0.05 mL) of ABP-938 by IVT injection in the study eye every 8 weeks from Week 16 until Week 48.

    Reporting group title
    Post Week 16: ABP 938 / ABP 938
    Reporting group description
    		 Participants who were initially treated with ABP 938 and remained on treatment with 2 mg (0.05 mL) of ABP 938 by IVT injection in the study eye every 8 weeks from Week 16 until Week 48.

    Serious adverse events
    		 Through Week 16: ABP 938 Through Week 16: Aflibercept Post Week 16: Aflibercept / Aflibercept Post Week 16: Aflibercept / ABP 938 Post Week 16: ABP 938 / ABP 938
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 288 (2.08%)
    9 / 288 (3.13%)
    11 / 136 (8.09%)
    14 / 133 (10.53%)
    22 / 273 (8.06%)
         number of deaths (all causes)
    0
    2
    0
    2
    2
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon cancer
         subjects affected / exposed
    0 / 288 (0.00%)
    1 / 288 (0.35%)
    0 / 136 (0.00%)
    0 / 133 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    0 / 288 (0.00%)
    1 / 288 (0.35%)
    0 / 136 (0.00%)
    1 / 133 (0.75%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Invasive lobular breast carcinoma
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 288 (0.00%)
    0 / 136 (0.00%)
    0 / 133 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 288 (0.00%)
    1 / 136 (0.74%)
    0 / 133 (0.00%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Plasma cell myeloma
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 288 (0.00%)
    0 / 136 (0.00%)
    1 / 133 (0.75%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 288 (0.00%)
    0 / 136 (0.00%)
    0 / 133 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small cell lung cancer
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 288 (0.00%)
    0 / 136 (0.00%)
    0 / 133 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rosai-Dorfman syndrome
         subjects affected / exposed
    1 / 288 (0.35%)
    0 / 288 (0.00%)
    0 / 136 (0.00%)
    0 / 133 (0.00%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of the tongue
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 288 (0.00%)
    0 / 136 (0.00%)
    1 / 133 (0.75%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transitional cell cancer of the renal pelvis and ureter
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 288 (0.00%)
    0 / 136 (0.00%)
    0 / 133 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 288 (0.00%)
    0 / 136 (0.00%)
    0 / 133 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transitional cell carcinoma
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 288 (0.00%)
    0 / 136 (0.00%)
    0 / 133 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Peripheral artery stenosis
         subjects affected / exposed
    0 / 288 (0.00%)
    1 / 288 (0.35%)
    0 / 136 (0.00%)
    0 / 133 (0.00%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subclavian artery stenosis
         subjects affected / exposed
    0 / 288 (0.00%)
    1 / 288 (0.35%)
    0 / 136 (0.00%)
    0 / 133 (0.00%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 288 (0.00%)
    0 / 136 (0.00%)
    0 / 133 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 288 (0.00%)
    0 / 136 (0.00%)
    0 / 133 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 288 (0.00%)
    1 / 136 (0.74%)
    0 / 133 (0.00%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 288 (0.00%)
    1 / 288 (0.35%)
    0 / 136 (0.00%)
    0 / 133 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Heart rate decreased
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 288 (0.00%)
    0 / 136 (0.00%)
    1 / 133 (0.75%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 288 (0.00%)
    0 / 136 (0.00%)
    1 / 133 (0.75%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    1 / 288 (0.35%)
    0 / 288 (0.00%)
    0 / 136 (0.00%)
    0 / 133 (0.00%)
    3 / 273 (1.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 288 (0.00%)
    0 / 136 (0.00%)
    0 / 133 (0.00%)
    2 / 273 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 288 (0.00%)
    0 / 136 (0.00%)
    1 / 133 (0.75%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 288 (0.00%)
    1 / 136 (0.74%)
    0 / 133 (0.00%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 288 (0.00%)
    0 / 136 (0.00%)
    1 / 133 (0.75%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 288 (0.00%)
    0 / 136 (0.00%)
    0 / 133 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    1 / 288 (0.35%)
    0 / 288 (0.00%)
    0 / 136 (0.00%)
    0 / 133 (0.00%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Ventricular tachycardia
         subjects affected / exposed
    1 / 288 (0.35%)
    0 / 288 (0.00%)
    0 / 136 (0.00%)
    0 / 133 (0.00%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 288 (0.00%)
    0 / 136 (0.00%)
    1 / 133 (0.75%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 288 (0.00%)
    1 / 288 (0.35%)
    1 / 136 (0.74%)
    0 / 133 (0.00%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 288 (0.00%)
    0 / 136 (0.00%)
    1 / 133 (0.75%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 288 (0.00%)
    0 / 136 (0.00%)
    0 / 133 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 288 (0.00%)
    0 / 136 (0.00%)
    0 / 133 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 288 (0.00%)
    0 / 136 (0.00%)
    3 / 133 (2.26%)
    2 / 273 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    Eye disorders
    Retinal detachment
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 288 (0.00%)
    0 / 136 (0.00%)
    0 / 133 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal haemorrhage
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 288 (0.00%)
    1 / 136 (0.74%)
    0 / 133 (0.00%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Visual acuity reduced
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 288 (0.00%)
    1 / 136 (0.74%)
    0 / 133 (0.00%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Visual impairment
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 288 (0.00%)
    1 / 136 (0.74%)
    0 / 133 (0.00%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Pneumatosis intestinalis
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 288 (0.00%)
    0 / 136 (0.00%)
    0 / 133 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 288 (0.00%)
    1 / 136 (0.74%)
    0 / 133 (0.00%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholangitis acute
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 288 (0.00%)
    1 / 136 (0.74%)
    0 / 133 (0.00%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 288 (0.35%)
    0 / 288 (0.00%)
    0 / 136 (0.00%)
    0 / 133 (0.00%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 288 (0.00%)
    0 / 136 (0.00%)
    0 / 133 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Bladder neck obstruction
         subjects affected / exposed
    1 / 288 (0.35%)
    0 / 288 (0.00%)
    0 / 136 (0.00%)
    0 / 133 (0.00%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Adrenal haematoma
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 288 (0.00%)
    0 / 136 (0.00%)
    0 / 133 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Haemarthrosis
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 288 (0.00%)
    1 / 136 (0.74%)
    0 / 133 (0.00%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Arthropod-borne disease
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 288 (0.00%)
    1 / 136 (0.74%)
    0 / 133 (0.00%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    0 / 288 (0.00%)
    2 / 288 (0.69%)
    0 / 136 (0.00%)
    0 / 133 (0.00%)
    2 / 273 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 288 (0.00%)
    0 / 136 (0.00%)
    1 / 133 (0.75%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 288 (0.35%)
    0 / 288 (0.00%)
    0 / 136 (0.00%)
    0 / 133 (0.00%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 288 (0.00%)
    1 / 288 (0.35%)
    0 / 136 (0.00%)
    1 / 133 (0.75%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 288 (0.00%)
    0 / 136 (0.00%)
    0 / 133 (0.00%)
    1 / 273 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 288 (0.00%)
    0 / 136 (0.00%)
    1 / 133 (0.75%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 288 (0.00%)
    0 / 136 (0.00%)
    1 / 133 (0.75%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 288 (0.00%)
    0 / 136 (0.00%)
    1 / 133 (0.75%)
    0 / 273 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Through Week 16: ABP 938 Through Week 16: Aflibercept Post Week 16: Aflibercept / Aflibercept Post Week 16: Aflibercept / ABP 938 Post Week 16: ABP 938 / ABP 938
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 288 (6.25%)
    15 / 288 (5.21%)
    17 / 136 (12.50%)
    17 / 133 (12.78%)
    20 / 273 (7.33%)
    Eye disorders
    Neovascular age-related macular degeneration
         subjects affected / exposed
    6 / 288 (2.08%)
    4 / 288 (1.39%)
    11 / 136 (8.09%)
    10 / 133 (7.52%)
    16 / 273 (5.86%)
         occurrences all number
    6
    4
    11
    10
    16
    Conjunctival haemorrhage
         subjects affected / exposed
    12 / 288 (4.17%)
    11 / 288 (3.82%)
    8 / 136 (5.88%)
    8 / 133 (6.02%)
    4 / 273 (1.47%)
         occurrences all number
    15
    13
    10
    11
    6

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Oct 2019
    Amendment 1: - Inclusion Criteria was updated. - Exclusion Criteria was updated. - Fundus photography was added as an efficacy assessment.
    23 Mar 2021
    Amendment 2: - Non-Amgen Investigational Product (Aflibercept) was updated to include additional adverse events reflected in the warnings and precautions section of the product labeling. - Benefit/Risk Assessment was updated to include a COVID-19 risk assessment. - Study Objective and Endpoints, 1 of the secondary efficacy endpoints was updated. - Study Design was updated to include information on the pharmacokinetic substudy and treatment of the fellow eye. - Inclusion Criteria was updated. - Exclusion Criteria was updated. - Antidrug Antibodies was updated. - Treatment of the Fellow Eye was updated. - A new section, Coronavirus Disease 2019 Considerations was included.
    16 May 2022
    Amendment 3: - Study Objectives, Endpoints, and Estimand was updated to include the information of primary estimand. - Primary Endpoint/Estimand was updated to include the analysis of primary estimand.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

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