Trial Outcomes & Findings for Study of Efficacy and Safety of Brolucizumab vs. Aflibercept in Chinese Patients With Neovascular Age-Related Macular Degeneration (NCT NCT04047472)

NCT ID: NCT04047472

Last Updated: 2024-12-09

Results Overview

BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. Last observation carried forward (LOCF) was used for the imputation of missing values.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 397 participants
• Primary outcome timeframe: Baseline, Week 48
• Results posted on: 2024-12-09

Participant Flow

Participant milestones

Measure	Brolucizumab 6 mg 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Overall Study STARTED	199	198
Overall Study COMPLETED	183	182
Overall Study NOT COMPLETED	16	16

Reasons for withdrawal

Measure	Brolucizumab 6 mg 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Overall Study Adverse Event	3	3
Overall Study Death	0	1
Overall Study Lost to Follow-up	1	0
Overall Study Physician Decision	1	2
Overall Study Protocol Violation	1	0
Overall Study Withdrawal by Subject	10	10

Baseline Characteristics

Study of Efficacy and Safety of Brolucizumab vs. Aflibercept in Chinese Patients With Neovascular Age-Related Macular Degeneration

Baseline characteristics by cohort

Measure	Brolucizumab 6 mg n=199 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg n=198 Participants 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.	Total n=397 Participants Total of all reporting groups
Age, Continuous	69.1 Years STANDARD_DEVIATION 7.58 • n=5 Participants	68.0 Years STANDARD_DEVIATION 7.68 • n=7 Participants	68.5 Years STANDARD_DEVIATION 7.64 • n=5 Participants
Sex: Female, Male Female	70 Participants n=5 Participants	54 Participants n=7 Participants	124 Participants n=5 Participants
Sex: Female, Male Male	129 Participants n=5 Participants	144 Participants n=7 Participants	273 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	199 Participants n=5 Participants	198 Participants n=7 Participants	397 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 48

Population: Full Analysis Set (FAS) Last Observation Carried Forward (LOCF)

BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.

Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included.

Min and max possible scores are 0-100 respectively. A higher score represents better functioning.

Last observation carried forward (LOCF) was used for the imputation of missing values.

Outcome measures

Measure	Brolucizumab 6 mg n=199 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg n=198 Participants 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Change From Baseline at Week 48 in Best-Corrected Visual Acuity in Study Eye	9.9 Letters Read Standard Error 0.82	10.9 Letters Read Standard Error 0.82

SECONDARY outcome

Timeframe: Baseline, over the period Week 36 to Week 48

Population: Full Analysis Set (FAS) Last Observation Carried Forward (LOCF)

BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.

Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included.

Min and max possible scores are 0-100 respectively. A higher score represents better functioning.

Last observation carried forward (LOCF) was used for the imputation of missing values.

Outcome measures

Measure	Brolucizumab 6 mg n=199 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg n=198 Participants 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Average Change From Baseline Over the Period of Week 36 to Week 48 in Best-Corrected Visual Acuity in Study Eye	9.7 Letters Read Standard Error 0.78	11.0 Letters Read Standard Error 0.79

SECONDARY outcome

Timeframe: Week 44

Population: Full Analysis Set (FAS)

The estimate for the proportion of participants with a positive q12w treatment status was derived from Kaplan-Meier time-to-event analyses for the event "first q8w-need", applying a "q8w-need" allocation in case of missing or confounded data attributable to lack of efficacy and/or lack of safety for the purpose of analysis. The proportion of participants with a positive q12w treatment status was derived as follows according to the "sufficient efficacy and safety" approach: the q8w-need assessment was imputed as "Yes" at the disease activity assessment (DAA) visit following early treatment/study discontinuation due to lack of efficacy and /or lack of safety of the study treatment (applicable to both missing and non-missing DAAs).

Outcome measures

Measure	Brolucizumab 6 mg n=199 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
q12w Treatment Status at Week 48 (for Subjects Randomized to Brolucizumab 6 mg Only) - Probability	0.595 Probability of no q8w-need Interval 0.529 to 0.655	—

SECONDARY outcome

Timeframe: Week 44

Population: FAS - Participants in the FAS randomized to brolucizumab 6 mg with no identified q8w-need at Week 16 and Week 20.

The estimate for the proportion of participants with a positive q12w treatment status was derived from Kaplan-Meier time-to-event analyses for the event "first q8w-need", applying a "q8w-need" allocation in case of missing or confounded data attributable to lack of efficacy and/or lack of safety for the purpose of analysis.

The analysis of "q12w treatment status within the participants randomized to brolucizumab 6 mg and with no q8w need during the first q12w cycle" was based on the subset of FAS participants randomized to brolucizumab 6 mg with no identified q8w-need at Week 16 and Week 20.

Outcome measures

Measure	Brolucizumab 6 mg n=117 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
q12w Treatment Status at Week 48 Within the Subjects With no q8w Need During the First q12w Cycle (Week 16 and Week 20) (for Subjects Randomized to Brolucizumab 6 mg Only) - Probability	0.860 Probability of no q8w-need Interval 0.791 to 0.908	—

SECONDARY outcome

Timeframe: Week 16

Population: Full Analysis Set (FAS) - for participants with a valid measurement

For both arms, the treatment was initiated with 3 monthly injections at Weeks 0, 4 and 8 (loading phase). Week 12 was scheduled as a "no injection visit" for both arms per protocol. Therefore, by Week 16, the planned treatment exposure was identical between the treatment arms, allowing a matched comparison of brolucizumab and aflibercept up to 8 weeks after loading.

Outcome measures

Measure	Brolucizumab 6 mg n=181 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg n=185 Participants 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Number (%) of Participants With q8w Treatment Need as Assessed by the Investigator at First Disease Activity Assessment (DAA) Visit	30 Participants	47 Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44

Population: Full Analysis Set (FAS) Last Observation Carried Forward (LOCF)

BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.

Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included.

Min and max possible scores are 0-100 respectively. A higher score represents better functioning.

Last observation carried forward (LOCF) was used for the imputation of missing values.

Outcome measures

Measure	Brolucizumab 6 mg n=199 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg n=198 Participants 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Change From Baseline at Each Study Visit in Best-Corrected Visual Acuity in Study Eye Week 4	3.9 Letters Read Standard Error 0.58	4.2 Letters Read Standard Error 0.58
Change From Baseline at Each Study Visit in Best-Corrected Visual Acuity in Study Eye Week 8	6.1 Letters Read Standard Error 0.61	6.5 Letters Read Standard Error 0.61
Change From Baseline at Each Study Visit in Best-Corrected Visual Acuity in Study Eye Week 12	7.4 Letters Read Standard Error 0.69	8.4 Letters Read Standard Error 0.69
Change From Baseline at Each Study Visit in Best-Corrected Visual Acuity in Study Eye Week 16	8.3 Letters Read Standard Error 0.74	9.4 Letters Read Standard Error 0.74
Change From Baseline at Each Study Visit in Best-Corrected Visual Acuity in Study Eye Week 20	8.2 Letters Read Standard Error 0.78	10.5 Letters Read Standard Error 0.79
Change From Baseline at Each Study Visit in Best-Corrected Visual Acuity in Study Eye Week 24	8.3 Letters Read Standard Error 0.81	10.0 Letters Read Standard Error 0.81
Change From Baseline at Each Study Visit in Best-Corrected Visual Acuity in Study Eye Week 28	9.1 Letters Read Standard Error 0.77	11.0 Letters Read Standard Error 0.77
Change From Baseline at Each Study Visit in Best-Corrected Visual Acuity in Study Eye Week 32	9.2 Letters Read Standard Error 0.78	10.7 Letters Read Standard Error 0.78
Change From Baseline at Each Study Visit in Best-Corrected Visual Acuity in Study Eye Week 36	9.1 Letters Read Standard Error 0.79	11.1 Letters Read Standard Error 0.80
Change From Baseline at Each Study Visit in Best-Corrected Visual Acuity in Study Eye Week 40	9.7 Letters Read Standard Error 0.79	10.9 Letters Read Standard Error 0.79
Change From Baseline at Each Study Visit in Best-Corrected Visual Acuity in Study Eye Week 44	10.0 Letters Read Standard Error 0.80	11.2 Letters Read Standard Error 0.80

SECONDARY outcome

Timeframe: Baseline, over the period of Week 4 or Week 12 to Week 48

Population: Full Analysis Set (FAS) Last Observation Carried Forward (LOCF)

BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.

Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included.

Min and max possible scores are 0-100 respectively. A higher score represents better functioning.

Last observation carried forward (LOCF) was used for the imputation of missing values.

Outcome measures

Measure	Brolucizumab 6 mg n=199 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg n=198 Participants 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Average Change From Baseline in Best Corrected Visual Acuity (Letters Read) From Week 4 or Week 12 up to Week 48 for the Study Eye Average change from baseline over the period Week 4 through Week 48	8.3 Letters Read Standard Error 0.68	9.6 Letters Read Standard Error 0.68
Average Change From Baseline in Best Corrected Visual Acuity (Letters Read) From Week 4 or Week 12 up to Week 48 for the Study Eye Average change from baseline over the period Week 12 through Week 48	8.9 Letters Read Standard Error 0.73	10.4 Letters Read Standard Error 0.74

SECONDARY outcome

Timeframe: Baseline up to Week 48

Population: Full Analysis Set (FAS) Last Observation Carried Forward (LOCF)

BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.

Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included.

Min and max possible scores are 0-100 respectively. A higher score represents better functioning.

Last observation carried forward (LOCF) was used for the imputation of missing values.

Outcome measures

Measure	Brolucizumab 6 mg n=199 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg n=198 Participants 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Number of Subjects With Best-Corrected Visual Acuity of 73 Letters or More at Each Visit Week 4	36 Participants	50 Participants
Number of Subjects With Best-Corrected Visual Acuity of 73 Letters or More at Each Visit Week 8	47 Participants	60 Participants
Number of Subjects With Best-Corrected Visual Acuity of 73 Letters or More at Each Visit Week 12	59 Participants	70 Participants
Number of Subjects With Best-Corrected Visual Acuity of 73 Letters or More at Each Visit Week 16	69 Participants	74 Participants
Number of Subjects With Best-Corrected Visual Acuity of 73 Letters or More at Each Visit Week 20	68 Participants	86 Participants
Number of Subjects With Best-Corrected Visual Acuity of 73 Letters or More at Each Visit Week 24	68 Participants	78 Participants
Number of Subjects With Best-Corrected Visual Acuity of 73 Letters or More at Each Visit Week 28	73 Participants	82 Participants
Number of Subjects With Best-Corrected Visual Acuity of 73 Letters or More at Each Visit Week 32	73 Participants	85 Participants
Number of Subjects With Best-Corrected Visual Acuity of 73 Letters or More at Each Visit Week 36	71 Participants	87 Participants
Number of Subjects With Best-Corrected Visual Acuity of 73 Letters or More at Each Visit Week 40	73 Participants	84 Participants
Number of Subjects With Best-Corrected Visual Acuity of 73 Letters or More at Each Visit Week 44	78 Participants	92 Participants
Number of Subjects With Best-Corrected Visual Acuity of 73 Letters or More at Each Visit Week 48	72 Participants	86 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 48

Population: Full Analysis Set (FAS) Last Observation carried Forward (LOCF)

BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.

Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included.

Min and max possible scores are 0-100 respectively. A higher score represents better functioning.

Last observation carried forward (LOCF) was used for the imputation of missing values.

Outcome measures

Measure	Brolucizumab 6 mg n=199 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg n=198 Participants 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5, ≥ 10 and ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA ≥ 84 Letters at Week 48 for the Study Eye Participants with ≥ 5 letters gain from baseline or reached BCVA of ≥ 84 letters at Week 48	139 Participants	146 Participants
Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5, ≥ 10 and ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA ≥ 84 Letters at Week 48 for the Study Eye Participants with ≥ 10 letters gain from baseline or reached BCVA of ≥ 84 letters at Week 48	103 Participants	104 Participants
Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5, ≥ 10 and ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA ≥ 84 Letters at Week 48 for the Study Eye Participants with ≥ 15 letters gain from baseline or reached BCVA of ≥ 84 letters at Week 48	68 Participants	73 Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48

Population: Full Analysis Set (FAS) Last Observation carried Forward (LOCF)

BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.

Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included.

Min and max possible scores are 0-100 respectively. A higher score represents better functioning.

Last observation carried forward (LOCF) was used for the imputation of missing values.

Outcome measures

Measure	Brolucizumab 6 mg n=199 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg n=198 Participants 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye Week 4	73 Participants	94 Participants
Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye Week 8	102 Participants	115 Participants
Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye Week 12	122 Participants	139 Participants
Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye Week 16	134 Participants	149 Participants
Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye Week 20	133 Participants	147 Participants
Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye Week 24	129 Participants	149 Participants
Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye Week 28	134 Participants	147 Participants
Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye Week 32	131 Participants	154 Participants
Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye Week 36	129 Participants	151 Participants
Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye Week 40	134 Participants	152 Participants
Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye Week 44	136 Participants	151 Participants
Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye Week 48	139 Participants	146 Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48

Population: Full Analysis Set (FAS) Last Observation carried Forward (LOCF)

BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.

Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included.

Min and max possible scores are 0-100 respectively. A higher score represents better functioning.

Last observation carried forward (LOCF) was used for the imputation of missing values.

Outcome measures

Measure	Brolucizumab 6 mg n=199 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg n=198 Participants 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 10 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye Week 4	39 Participants	35 Participants
Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 10 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye Week 8	57 Participants	59 Participants
Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 10 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye Week 12	79 Participants	85 Participants
Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 10 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye Week 16	88 Participants	93 Participants
Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 10 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye Week 20	86 Participants	107 Participants
Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 10 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye Week 24	90 Participants	98 Participants
Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 10 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye Week 28	91 Participants	108 Participants
Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 10 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye Week 32	95 Participants	107 Participants
Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 10 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye Week 36	94 Participants	108 Participants
Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 10 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye Week 40	102 Participants	98 Participants
Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 10 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye Week 44	101 Participants	107 Participants
Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 10 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye Week 48	103 Participants	104 Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48

Population: Full Analysis Set (FAS) Last Observation carried Forward (LOCF)

BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.

Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included.

Min and max possible scores are 0-100 respectively. A higher score represents better functioning.

Last observation carried forward (LOCF) was used for the imputation of missing values.

Outcome measures

Measure	Brolucizumab 6 mg n=199 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg n=198 Participants 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye Week 8	37 Participants	28 Participants
Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye Week 4	21 Participants	19 Participants
Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye Week 12	49 Participants	48 Participants
Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye Week 16	56 Participants	55 Participants
Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye Week 20	57 Participants	59 Participants
Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye Week 24	57 Participants	54 Participants
Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye Week 28	61 Participants	64 Participants
Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye Week 32	62 Participants	64 Participants
Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye Week 36	64 Participants	69 Participants
Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye Week 40	66 Participants	68 Participants
Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye Week 44	63 Participants	69 Participants
Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye Week 48	68 Participants	73 Participants

SECONDARY outcome

Timeframe: Baseline, Week 48

Population: Full Analysis Set (FAS) Last Observation carried Forward (LOCF)

BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.

Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included.

Min and max possible scores are 0-100 respectively. A higher score represents better functioning.

Last observation carried forward (LOCF) was used for the imputation of missing values.

Outcome measures

Measure	Brolucizumab 6 mg n=199 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg n=198 Participants 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5, ≥ 10 and ≥ 15 Letters in Best-correct Visual Acuity From Baseline at Week 48 for the Study Eye Participants with ≥ 5 letters loss from baseline at Week 48	16 Participants	11 Participants
Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5, ≥ 10 and ≥ 15 Letters in Best-correct Visual Acuity From Baseline at Week 48 for the Study Eye Participants with ≥ 10 letters loss from baseline at Week 48	7 Participants	6 Participants
Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5, ≥ 10 and ≥ 15 Letters in Best-correct Visual Acuity From Baseline at Week 48 for the Study Eye Participants with ≥ 15 letters loss from baseline at Week 48	5 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48

Population: Full Analysis Set (FAS) Last Observation carried Forward (LOCF)

BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.

Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included.

Min and max possible scores are 0-100 respectively. A higher score represents better functioning.

Last observation carried forward (LOCF) was used for the imputation of missing values.

Outcome measures

Measure	Brolucizumab 6 mg n=199 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg n=198 Participants 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study Week 4	20 Participants	15 Participants
Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study Week 8	19 Participants	15 Participants
Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study Week 12	14 Participants	8 Participants
Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study Week 16	18 Participants	10 Participants
Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study Week 20	20 Participants	8 Participants
Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study Week 24	18 Participants	13 Participants
Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study Week 28	17 Participants	9 Participants
Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study Week 32	14 Participants	13 Participants
Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study Week 36	15 Participants	10 Participants
Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study Week 40	13 Participants	10 Participants
Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study Week 44	14 Participants	9 Participants
Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study Week 48	16 Participants	11 Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48

Population: Full Analysis Set (FAS) Last Observation carried Forward (LOCF)

BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.

Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included.

Min and max possible scores are 0-100 respectively. A higher score represents better functioning.

Last observation carried forward (LOCF) was used for the imputation of missing values.

Outcome measures

Measure	Brolucizumab 6 mg n=199 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg n=198 Participants 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 10 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study Week 48	7 Participants	6 Participants
Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 10 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study Week 4	6 Participants	6 Participants
Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 10 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study Week 8	5 Participants	4 Participants
Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 10 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study Week 12	6 Participants	4 Participants
Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 10 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study Week 16	6 Participants	4 Participants
Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 10 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study Week 20	9 Participants	5 Participants
Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 10 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study Week 24	13 Participants	5 Participants
Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 10 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study Week 28	8 Participants	4 Participants
Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 10 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study Week 32	9 Participants	5 Participants
Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 10 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study Week 36	8 Participants	5 Participants
Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 10 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study Week 40	6 Participants	6 Participants
Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 10 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study Week 44	7 Participants	6 Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48

Population: Full Analysis Set (FAS) Last Observation carried Forward (LOCF)

BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.

Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included.

Min and max possible scores are 0-100 respectively. A higher score represents better functioning.

Last observation carried forward (LOCF) was used for the imputation of missing values.

Outcome measures

Measure	Brolucizumab 6 mg n=199 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg n=198 Participants 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 15 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study Week 4	2 Participants	5 Participants
Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 15 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study Week 8	2 Participants	3 Participants
Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 15 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study Week 12	5 Participants	3 Participants
Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 15 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study Week 16	6 Participants	4 Participants
Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 15 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study Week 20	7 Participants	4 Participants
Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 15 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study Week 24	9 Participants	3 Participants
Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 15 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study Week 28	5 Participants	4 Participants
Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 15 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study Week 32	5 Participants	3 Participants
Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 15 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study Week 36	6 Participants	2 Participants
Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 15 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study Week 40	6 Participants	4 Participants
Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 15 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study Week 44	5 Participants	3 Participants
Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 15 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study Week 48	5 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline, over the period Week 4 through Week 48

Population: Full Analysis Set (FAS) Last Observation Carried Forward (LOCF)

Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center.

Central subfield thickness (CSFT) is a key anatomical parameter of central macula and is the average thickness in the center subfield as measured from the Internal Limiting Membrane (ILM) to the Bruch's Membrane (BM). The center subfield is the circular region centered on the anatomic fovea with the radius of 500 μm.

Outcome measures

Measure	Brolucizumab 6 mg n=199 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg n=198 Participants 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Average Change From Baseline Over the Period Week 4 Through Week 48 in Central Subfield Thickness - Total in Study Eye	-181.2 μm Standard Error 7.46	-161.9 μm Standard Error 7.48

SECONDARY outcome

Timeframe: Baseline, over the period Week 36 to Week 48

Population: Full Analysis Set (FAS) Last Observation Carried Forward (LOCF)

Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center.

Central subfield thickness (CSFT) is a key anatomical parameter of central macula and is the average thickness in the center subfield as measured from the Internal Limiting Membrane (ILM) to the Bruch's Membrane (BM).

The center subfield is the circular region centered on the anatomic fovea with the radius of 500 μm.

Outcome measures

Measure	Brolucizumab 6 mg n=199 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg n=198 Participants 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Average Change From Baseline Over the Period Week 36 Through 48 in Central Subfield Thickness - Total in Study Eye	-187.9 μm Standard Error 8.38	-167.2 μm Standard Error 8.40

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48

Population: Full Analysis Set (FAS) Last Observation Carried Forward (LOCF)

Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center.

Central subfield thickness (CSFT) is a key anatomical parameter of central macula and is the average thickness in the center subfield as measured from the Internal Limiting Membrane (ILM) to the Bruch's Membrane (BM).

The center subfield is the circular region centered on the anatomic fovea with the radius of 500 μm.

Outcome measures

Measure	Brolucizumab 6 mg n=199 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg n=198 Participants 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Change From Baseline at Each Study Visit in Central Subfield Thickness - Total in Study Eye Week 4	-148.5 μm Standard Error 6.50	-132.5 μm Standard Error 6.51
Change From Baseline at Each Study Visit in Central Subfield Thickness - Total in Study Eye Week 8	-183.3 μm Standard Error 6.95	-161.8 μm Standard Error 6.97
Change From Baseline at Each Study Visit in Central Subfield Thickness - Total in Study Eye Week 12	-193.2 μm Standard Error 7.22	-169.9 μm Standard Error 7.24
Change From Baseline at Each Study Visit in Central Subfield Thickness - Total in Study Eye Week 16	-179.5 μm Standard Error 7.99	-152.6 μm Standard Error 8.01
Change From Baseline at Each Study Visit in Central Subfield Thickness - Total in Study Eye Week 20	-172.2 μm Standard Error 7.91	-175.6 μm Standard Error 7.93
Change From Baseline at Each Study Visit in Central Subfield Thickness - Total in Study Eye Week 24	-185.2 μm Standard Error 8.33	-152.0 μm Standard Error 8.35
Change From Baseline at Each Study Visit in Central Subfield Thickness - Total in Study Eye Week 28	-186.8 μm Standard Error 8.06	-172.0 μm Standard Error 8.08
Change From Baseline at Each Study Visit in Central Subfield Thickness - Total in Study Eye Week 32	-174.0 μm Standard Error 8.37	-157.2 μm Standard Error 8.39
Change From Baseline at Each Study Visit in Central Subfield Thickness - Total in Study Eye Week 36	-191.2 μm Standard Error 8.29	-171.3 μm Standard Error 8.31
Change From Baseline at Each Study Visit in Central Subfield Thickness - Total in Study Eye Week 40	-184.6 μm Standard Error 8.57	-159.0 μm Standard Error 8.59
Change From Baseline at Each Study Visit in Central Subfield Thickness - Total in Study Eye Week 44	-184.7 μm Standard Error 8.64	-175.3 μm Standard Error 8.66
Change From Baseline at Each Study Visit in Central Subfield Thickness - Total in Study Eye Week 48	-191.1 μm Standard Error 8.71	-163.2 μm Standard Error 8.73

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48

Population: Full Analysis Set (FAS) Last Observation Carried Forward (LOCF)

Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center.

The central subfield thickness-neurosensory retina (CSFTns) is the average thickness in the center subfield as measured from the Internal Limiting Membrane (ILM) to the outer segment tips.

The center subfield is the circular region centered on the anatomic fovea with the radius of 500μm.

Outcome measures

Measure	Brolucizumab 6 mg n=199 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg n=198 Participants 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Change From Baseline at Each Study Visit in Central Subfield Thickness - Neurosensory Retina (μm) in Study Eye Week 4	-57.2 μm Standard Error 4.55	-48.3 μm Standard Error 4.57
Change From Baseline at Each Study Visit in Central Subfield Thickness - Neurosensory Retina (μm) in Study Eye Week 8	-65.4 μm Standard Error 4.94	-53.2 μm Standard Error 4.95
Change From Baseline at Each Study Visit in Central Subfield Thickness - Neurosensory Retina (μm) in Study Eye Week 12	-68.6 μm Standard Error 5.11	-53.2 μm Standard Error 5.12
Change From Baseline at Each Study Visit in Central Subfield Thickness - Neurosensory Retina (μm) in Study Eye Week 16	-63.8 μm Standard Error 5.22	-48.4 μm Standard Error 5.24
Change From Baseline at Each Study Visit in Central Subfield Thickness - Neurosensory Retina (μm) in Study Eye Week 20	-60.8 μm Standard Error 5.44	-56.4 μm Standard Error 5.45
Change From Baseline at Each Study Visit in Central Subfield Thickness - Neurosensory Retina (μm) in Study Eye Week 24	-67.0 μm Standard Error 5.22	-49.9 μm Standard Error 5.23
Change From Baseline at Each Study Visit in Central Subfield Thickness - Neurosensory Retina (μm) in Study Eye Week 28	-67.2 μm Standard Error 5.28	-54.5 μm Standard Error 5.29
Change From Baseline at Each Study Visit in Central Subfield Thickness - Neurosensory Retina (μm) in Study Eye Week 32	-62.7 μm Standard Error 5.26	-50.1 μm Standard Error 5.27
Change From Baseline at Each Study Visit in Central Subfield Thickness - Neurosensory Retina (μm) in Study Eye Week 36	-69.2 μm Standard Error 5.42	-56.3 μm Standard Error 5.43
Change From Baseline at Each Study Visit in Central Subfield Thickness - Neurosensory Retina (μm) in Study Eye Week 40	-67.9 μm Standard Error 5.45	-52.7 μm Standard Error 5.46
Change From Baseline at Each Study Visit in Central Subfield Thickness - Neurosensory Retina (μm) in Study Eye Week 44	-67.8 μm Standard Error 5.53	-57.2 μm Standard Error 5.54
Change From Baseline at Each Study Visit in Central Subfield Thickness - Neurosensory Retina (μm) in Study Eye Week 48	-69.7 μm Standard Error 5.38	-53.0 μm Standard Error 5.39

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48

Population: Full Analysis Set (FAS) Last Observation Carried Forward (LOCF)

Outcome measures

Measure	Brolucizumab 6 mg n=199 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg n=198 Participants 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Number of Participants With Presence of Subretinal Field (SRF) and/or Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye at Each Postbaseline Visit (and Specifically Week 16 and Week 48) Week 40	40 Participants	56 Participants
Number of Participants With Presence of Subretinal Field (SRF) and/or Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye at Each Postbaseline Visit (and Specifically Week 16 and Week 48) Week 44	45 Participants	37 Participants
Number of Participants With Presence of Subretinal Field (SRF) and/or Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye at Each Postbaseline Visit (and Specifically Week 16 and Week 48) Week 48	35 Participants	52 Participants
Number of Participants With Presence of Subretinal Field (SRF) and/or Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye at Each Postbaseline Visit (and Specifically Week 16 and Week 48) Week 4	78 Participants	92 Participants
Number of Participants With Presence of Subretinal Field (SRF) and/or Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye at Each Postbaseline Visit (and Specifically Week 16 and Week 48) Week 8	32 Participants	51 Participants
Number of Participants With Presence of Subretinal Field (SRF) and/or Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye at Each Postbaseline Visit (and Specifically Week 16 and Week 48) Week 12	33 Participants	44 Participants
Number of Participants With Presence of Subretinal Field (SRF) and/or Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye at Each Postbaseline Visit (and Specifically Week 16 and Week 48) Week 16	41 Participants	63 Participants
Number of Participants With Presence of Subretinal Field (SRF) and/or Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye at Each Postbaseline Visit (and Specifically Week 16 and Week 48) Week 20	55 Participants	37 Participants
Number of Participants With Presence of Subretinal Field (SRF) and/or Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye at Each Postbaseline Visit (and Specifically Week 16 and Week 48) Week 24	39 Participants	63 Participants
Number of Participants With Presence of Subretinal Field (SRF) and/or Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye at Each Postbaseline Visit (and Specifically Week 16 and Week 48) Week 28	44 Participants	40 Participants
Number of Participants With Presence of Subretinal Field (SRF) and/or Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye at Each Postbaseline Visit (and Specifically Week 16 and Week 48) Week 32	55 Participants	57 Participants
Number of Participants With Presence of Subretinal Field (SRF) and/or Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye at Each Postbaseline Visit (and Specifically Week 16 and Week 48) Week 36	37 Participants	40 Participants

SECONDARY outcome

Timeframe: Between Weeks 36 and Weeks 48

Population: Full Analysis Set (FAS) Last Observation Carried Forward (LOCF)

Outcome measures

Measure	Brolucizumab 6 mg n=199 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg n=198 Participants 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Number of Participants With Absence of Subretinal Field (SRF) and Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye Between Week 36 and Week 48 0 visits with no fluid between Week 36 to 48	18 Participants	24 Participants
Number of Participants With Absence of Subretinal Field (SRF) and Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye Between Week 36 and Week 48 1 visit with no fluid between Week 36 to 48	13 Participants	12 Participants
Number of Participants With Absence of Subretinal Field (SRF) and Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye Between Week 36 and Week 48 2 visits with no fluid between Week 36 to 48	15 Participants	18 Participants
Number of Participants With Absence of Subretinal Field (SRF) and Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye Between Week 36 and Week 48 3 visits with no fluid between Week 36 to 48	16 Participants	17 Participants
Number of Participants With Absence of Subretinal Field (SRF) and Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye Between Week 36 and Week 48 4 visits with no fluid between Week 36 to 48	137 Participants	127 Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48

Population: Full Analysis Set (FAS) Last Observation Carried Forward (LOCF)

Outcome measures

Measure	Brolucizumab 6 mg n=199 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg n=198 Participants 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Subretinal Fluid (SRF) Status in the Central Subfield: Number of Subjects With Presence of SRF by Visit for the Study Eye Baseline	149 Participants	156 Participants
Subretinal Fluid (SRF) Status in the Central Subfield: Number of Subjects With Presence of SRF by Visit for the Study Eye Week 4	63 Participants	83 Participants
Subretinal Fluid (SRF) Status in the Central Subfield: Number of Subjects With Presence of SRF by Visit for the Study Eye Week 8	19 Participants	42 Participants
Subretinal Fluid (SRF) Status in the Central Subfield: Number of Subjects With Presence of SRF by Visit for the Study Eye Week 12	18 Participants	34 Participants
Subretinal Fluid (SRF) Status in the Central Subfield: Number of Subjects With Presence of SRF by Visit for the Study Eye Week 16	30 Participants	50 Participants
Subretinal Fluid (SRF) Status in the Central Subfield: Number of Subjects With Presence of SRF by Visit for the Study Eye Week 20	35 Participants	28 Participants
Subretinal Fluid (SRF) Status in the Central Subfield: Number of Subjects With Presence of SRF by Visit for the Study Eye Week 24	26 Participants	49 Participants
Subretinal Fluid (SRF) Status in the Central Subfield: Number of Subjects With Presence of SRF by Visit for the Study Eye Week 28	29 Participants	31 Participants
Subretinal Fluid (SRF) Status in the Central Subfield: Number of Subjects With Presence of SRF by Visit for the Study Eye Week 32	34 Participants	46 Participants
Subretinal Fluid (SRF) Status in the Central Subfield: Number of Subjects With Presence of SRF by Visit for the Study Eye Week 36	21 Participants	35 Participants
Subretinal Fluid (SRF) Status in the Central Subfield: Number of Subjects With Presence of SRF by Visit for the Study Eye Week 40	24 Participants	49 Participants
Subretinal Fluid (SRF) Status in the Central Subfield: Number of Subjects With Presence of SRF by Visit for the Study Eye Week 44	27 Participants	32 Participants
Subretinal Fluid (SRF) Status in the Central Subfield: Number of Subjects With Presence of SRF by Visit for the Study Eye Week 48	20 Participants	43 Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48

Population: Full Analysis Set (FAS) Last Observation Carried Forward (LOCF)

Outcome measures

Measure	Brolucizumab 6 mg n=199 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg n=198 Participants 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Intraretinal Fluid (IRF) Status in the Central Subfield: Number of Subjects With Presence of IRF by Visit for the Study Eye Baseline	83 Participants	81 Participants
Intraretinal Fluid (IRF) Status in the Central Subfield: Number of Subjects With Presence of IRF by Visit for the Study Eye Week 4	26 Participants	17 Participants
Intraretinal Fluid (IRF) Status in the Central Subfield: Number of Subjects With Presence of IRF by Visit for the Study Eye Week 8	15 Participants	13 Participants
Intraretinal Fluid (IRF) Status in the Central Subfield: Number of Subjects With Presence of IRF by Visit for the Study Eye Week 12	15 Participants	13 Participants
Intraretinal Fluid (IRF) Status in the Central Subfield: Number of Subjects With Presence of IRF by Visit for the Study Eye Week 16	13 Participants	22 Participants
Intraretinal Fluid (IRF) Status in the Central Subfield: Number of Subjects With Presence of IRF by Visit for the Study Eye Week 20	23 Participants	10 Participants
Intraretinal Fluid (IRF) Status in the Central Subfield: Number of Subjects With Presence of IRF by Visit for the Study Eye Week 24	15 Participants	19 Participants
Intraretinal Fluid (IRF) Status in the Central Subfield: Number of Subjects With Presence of IRF by Visit for the Study Eye Week 28	15 Participants	9 Participants
Intraretinal Fluid (IRF) Status in the Central Subfield: Number of Subjects With Presence of IRF by Visit for the Study Eye Week 32	23 Participants	14 Participants
Intraretinal Fluid (IRF) Status in the Central Subfield: Number of Subjects With Presence of IRF by Visit for the Study Eye Week 36	17 Participants	6 Participants
Intraretinal Fluid (IRF) Status in the Central Subfield: Number of Subjects With Presence of IRF by Visit for the Study Eye Week 40	21 Participants	13 Participants
Intraretinal Fluid (IRF) Status in the Central Subfield: Number of Subjects With Presence of IRF by Visit for the Study Eye Week 44	22 Participants	7 Participants
Intraretinal Fluid (IRF) Status in the Central Subfield: Number of Subjects With Presence of IRF by Visit for the Study Eye Week 48	16 Participants	13 Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48

Population: Full Analysis Set (FAS) Last Observation Carried Forward (LOCF)

Outcome measures

Measure	Brolucizumab 6 mg n=199 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg n=198 Participants 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Subretinal Pigment Epithelium (Sub-RPE) Fluid Status in the Central Subfield: Number of Subjects With Presence of Sub-RPE by Visit for the Study Eye Baseline	26 Participants	32 Participants
Subretinal Pigment Epithelium (Sub-RPE) Fluid Status in the Central Subfield: Number of Subjects With Presence of Sub-RPE by Visit for the Study Eye Week 4	11 Participants	20 Participants
Subretinal Pigment Epithelium (Sub-RPE) Fluid Status in the Central Subfield: Number of Subjects With Presence of Sub-RPE by Visit for the Study Eye Week 8	7 Participants	17 Participants
Subretinal Pigment Epithelium (Sub-RPE) Fluid Status in the Central Subfield: Number of Subjects With Presence of Sub-RPE by Visit for the Study Eye Week 12	10 Participants	13 Participants
Subretinal Pigment Epithelium (Sub-RPE) Fluid Status in the Central Subfield: Number of Subjects With Presence of Sub-RPE by Visit for the Study Eye Week 16	12 Participants	15 Participants
Subretinal Pigment Epithelium (Sub-RPE) Fluid Status in the Central Subfield: Number of Subjects With Presence of Sub-RPE by Visit for the Study Eye Week 20	9 Participants	9 Participants
Subretinal Pigment Epithelium (Sub-RPE) Fluid Status in the Central Subfield: Number of Subjects With Presence of Sub-RPE by Visit for the Study Eye Week 24	10 Participants	10 Participants
Subretinal Pigment Epithelium (Sub-RPE) Fluid Status in the Central Subfield: Number of Subjects With Presence of Sub-RPE by Visit for the Study Eye Week 28	6 Participants	7 Participants
Subretinal Pigment Epithelium (Sub-RPE) Fluid Status in the Central Subfield: Number of Subjects With Presence of Sub-RPE by Visit for the Study Eye Week 32	5 Participants	10 Participants
Subretinal Pigment Epithelium (Sub-RPE) Fluid Status in the Central Subfield: Number of Subjects With Presence of Sub-RPE by Visit for the Study Eye Week 36	8 Participants	7 Participants
Subretinal Pigment Epithelium (Sub-RPE) Fluid Status in the Central Subfield: Number of Subjects With Presence of Sub-RPE by Visit for the Study Eye Week 40	6 Participants	10 Participants
Subretinal Pigment Epithelium (Sub-RPE) Fluid Status in the Central Subfield: Number of Subjects With Presence of Sub-RPE by Visit for the Study Eye Week 44	5 Participants	8 Participants
Subretinal Pigment Epithelium (Sub-RPE) Fluid Status in the Central Subfield: Number of Subjects With Presence of Sub-RPE by Visit for the Study Eye Week 48	6 Participants	9 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12 and Week 48

Population: Full Analysis Set (FAS) Last Observation Carried Forward (LOCF)

Outcome measures

Measure	Brolucizumab 6 mg n=199 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg n=198 Participants 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Change From Baseline at Weeks 12 and 48 in Choroidal Neovascularization (CNV) Lesion in Study Eye Week 12	-1.395 mm^2 Standard Error 0.1613	-1.378 mm^2 Standard Error 0.1617
Change From Baseline at Weeks 12 and 48 in Choroidal Neovascularization (CNV) Lesion in Study Eye Week 48	-2.034 mm^2 Standard Error 0.2002	-1.984 mm^2 Standard Error 0.2007

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 48

Population: Safety Analysis Set

As assessed by color fundus photography.

Outcome measures

Measure	Brolucizumab 6 mg n=199 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg n=198 Participants 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Number of Subjects With Presence of Fibrosis (Central Subfield) in the Study Eye by Visit Baseline	0 Participants	0 Participants
Number of Subjects With Presence of Fibrosis (Central Subfield) in the Study Eye by Visit Week 12 (n=182, 177)	15 Participants	17 Participants
Number of Subjects With Presence of Fibrosis (Central Subfield) in the Study Eye by Visit Week 48 (n=166,164)	18 Participants	24 Participants

SECONDARY outcome

Timeframe: Baseline, Week 24 and Week 48

Population: Full Analysis Set - Observed - for participants with a valid measurement

The VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score was calculated by averaging vision-targeted subscale scores, excluding the general health rating question. All items are scored so that a high score represents better visual functioning.

Outcome measures

Measure	Brolucizumab 6 mg n=172 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg n=169 Participants 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Composite Score Week 24	3.0 Scores on a Scale Standard Deviation 13.03	3.7 Scores on a Scale Standard Deviation 12.94
Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Composite Score Week 48 (n=165,159)	4.1 Scores on a Scale Standard Deviation 14.00	2.9 Scores on a Scale Standard Deviation 13.69

SECONDARY outcome

Timeframe: Baseline, Week 24 and Week 48

Population: Full Analysis Set - Observed - for participants with a valid measurement

The VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score was calculated by averaging vision-targeted subscale scores, excluding the general health rating question. All items are scored so that a high score represents better visual functioning.

Outcome measures

Measure	Brolucizumab 6 mg n=172 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg n=169 Participants 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - General Vision Week 24	7.7 Scores on a Scale Standard Deviation 17.88	7.8 Scores on a Scale Standard Deviation 17.47
Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - General Vision Week 48 (n=165,159)	9.0 Scores on a Scale Standard Deviation 19.68	6.4 Scores on a Scale Standard Deviation 16.89

SECONDARY outcome

Timeframe: Baseline, Week 24 and Week 48

Population: Full Analysis Set - Observed - for participants with a valid measurement

The VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score was calculated by averaging vision-targeted subscale scores, excluding the general health rating question. All items are scored so that a high score represents better visual functioning.

Outcome measures

Measure	Brolucizumab 6 mg n=172 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg n=169 Participants 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Ocular Pain Week 24	0.9 Scores on a Scale Standard Deviation 17.68	6.1 Scores on a Scale Standard Deviation 15.74
Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Ocular Pain Week 48 (n=165,159)	1.0 Scores on a Scale Standard Deviation 19.37	3.1 Scores on a Scale Standard Deviation 17.88

SECONDARY outcome

Timeframe: Baseline, Week 24 and Week 48

Population: Full Analysis Set - Observed - for participants with a valid measurement

The VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score was calculated by averaging vision-targeted subscale scores, excluding the general health rating question. All items are scored so that a high score represents better visual functioning.

Outcome measures

Measure	Brolucizumab 6 mg n=170 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg n=167 Participants 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Near Activities Week 24	5.3 Scores on a Scale Standard Deviation 22.02	5.8 Scores on a Scale Standard Deviation 21.03
Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Near Activities Week 48 (n=162,157)	8.1 Scores on a Scale Standard Deviation 23.28	5.7 Scores on a Scale Standard Deviation 22.64

SECONDARY outcome

Timeframe: Baseline, Week 24 and Week 48

Population: Full Analysis Set - Observed - for participants with a valid measurement

The VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score was calculated by averaging vision-targeted subscale scores, excluding the general health rating question. All items are scored so that a high score represents better visual functioning.

Outcome measures

Measure	Brolucizumab 6 mg n=172 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg n=169 Participants 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Distance Activities Week 24	2.2 Scores on a Scale Standard Deviation 21.09	4.2 Scores on a Scale Standard Deviation 20.07
Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Distance Activities Week 48 (n=163,159)	3.8 Scores on a Scale Standard Deviation 20.62	4.8 Scores on a Scale Standard Deviation 21.11

SECONDARY outcome

Timeframe: Baseline, Week 24 and Week 48

Population: Full Analysis Set - Observed - for participants with a valid measurement

The VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score was calculated by averaging vision-targeted subscale scores, excluding the general health rating question. All items are scored so that a high score represents better visual functioning.

Outcome measures

Measure	Brolucizumab 6 mg n=172 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg n=169 Participants 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Social Functioning Week 24	1.5 Scores on a Scale Standard Deviation 13.44	2.4 Scores on a Scale Standard Deviation 14.50
Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Social Functioning Week 48 (n=165,159)	2.3 Scores on a Scale Standard Deviation 14.90	0.8 Scores on a Scale Standard Deviation 15.83

SECONDARY outcome

Timeframe: Baseline, Week 24 and Week 48

Population: Full Analysis Set - Observed - for participants with a valid measurement

The VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score was calculated by averaging vision-targeted subscale scores, excluding the general health rating question. All items are scored so that a high score represents better visual functioning.

Outcome measures

Measure	Brolucizumab 6 mg n=172 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg n=169 Participants 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Mental Health Week 24	4.6 Scores on a Scale Standard Deviation 25.61	0.6 Scores on a Scale Standard Deviation 20.34
Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Mental Health Week 48 (n=165,159)	4.7 Scores on a Scale Standard Deviation 22.46	1.0 Scores on a Scale Standard Deviation 21.55

SECONDARY outcome

Timeframe: Baseline, Week 24 and Week 48

Population: Full Analysis Set - Observed - for participants with a valid measurement

The VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score was calculated by averaging vision-targeted subscale scores, excluding the general health rating question. All items are scored so that a high score represents better visual functioning.

Outcome measures

Measure	Brolucizumab 6 mg n=172 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg n=169 Participants 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Role Difficulties Week 24	0.5 Scores on a Scale Standard Deviation 27.25	3.8 Scores on a Scale Standard Deviation 25.91
Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Role Difficulties Week 48 (n=165,159)	4.5 Scores on a Scale Standard Deviation 25.23	2.7 Scores on a Scale Standard Deviation 25.68

SECONDARY outcome

Timeframe: Baseline, Week 24 and Week 48

Population: Full Analysis Set - Observed - for participants with a valid measurement

The VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score was calculated by averaging vision-targeted subscale scores, excluding the general health rating question. All items are scored so that a high score represents better visual functioning.

Outcome measures

Measure	Brolucizumab 6 mg n=172 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg n=169 Participants 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Dependency Week 24	3.9 Scores on a Scale Standard Deviation 28.38	2.1 Scores on a Scale Standard Deviation 24.29
Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Dependency Week 48 (n=165,159)	6.6 Scores on a Scale Standard Deviation 27.85	0.6 Scores on a Scale Standard Deviation 26.50

SECONDARY outcome

Timeframe: Baseline, Week 24 and Week 48

Population: Full Analysis Set - Observed - for participants with a valid measurement

The VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score was calculated by averaging vision-targeted subscale scores, excluding the general health rating question. All items are scored so that a high score represents better visual functioning.

Outcome measures

Measure	Brolucizumab 6 mg n=34 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg n=43 Participants 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Driving Week 24 (n=33, 43)	3.4 Scores on a Scale Standard Deviation 15.50	0.8 Scores on a Scale Standard Deviation 19.65
Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Driving Week 48 (n=34,37)	3.9 Scores on a Scale Standard Deviation 17.28	4.6 Scores on a Scale Standard Deviation 15.80

SECONDARY outcome

Timeframe: Baseline, Week 24 and Week 48

Population: Full Analysis Set - Observed - for participants with a valid measurement

The VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score was calculated by averaging vision-targeted subscale scores, excluding the general health rating question. All items are scored so that a high score represents better visual functioning.

Outcome measures

Measure	Brolucizumab 6 mg n=167 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg n=162 Participants 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Color Vision Week 24	1.3 Scores on a Scale Standard Deviation 12.95	2.2 Scores on a Scale Standard Deviation 18.36
Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Color Vision Week 48 (n=161,155)	0.6 Scores on a Scale Standard Deviation 15.55	0.5 Scores on a Scale Standard Deviation 14.93

SECONDARY outcome

Timeframe: Baseline, Week 24 and Week 48

Population: Full Analysis Set - Observed - for participants with a valid measurement

The VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score was calculated by averaging vision-targeted subscale scores, excluding the general health rating question. All items are scored so that a high score represents better visual functioning.

Outcome measures

Measure	Brolucizumab 6 mg n=172 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg n=168 Participants 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Peripheral Vision Week 24	1.6 Scores on a Scale Standard Deviation 17.76	2.4 Scores on a Scale Standard Deviation 16.92
Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Peripheral Vision Week 48 (n=164,158)	0.5 Scores on a Scale Standard Deviation 18.67	1.4 Scores on a Scale Standard Deviation 19.60

SECONDARY outcome

Timeframe: Baseline, Week 24 and Week 48

Population: Full Analysis Set - Observed - for participants with a valid measurement

The VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score was calculated by averaging vision-targeted subscale scores, excluding the general health rating question. All items are scored so that a high score represents better visual functioning.

Outcome measures

Measure	Brolucizumab 6 mg n=172 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg n=169 Participants 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - General Health Rating Week 24	-3.6 Scores on a Scale Standard Deviation 24.13	0.7 Scores on a Scale Standard Deviation 24.00
Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - General Health Rating Week 48 (n=165,159)	-4.4 Scores on a Scale Standard Deviation 24.84	-2.7 Scores on a Scale Standard Deviation 26.62

SECONDARY outcome

Timeframe: Baseline

Population: Safety Analysis Set - for a subset of treated participants with a valid measurement

To assess immunogenicity of brolucizumab 6 mg.

Outcome measures

Measure	Brolucizumab 6 mg n=198 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Anti-drug Antibody (ADA): Frequency Distribution of Pre-dose ADA Status in the Brolucizumab Arm Pre-dose ADA Status = Negative	82 Participants	—
Anti-drug Antibody (ADA): Frequency Distribution of Pre-dose ADA Status in the Brolucizumab Arm Pre-dose ADA Status = Positive	116 Participants	—

SECONDARY outcome

Timeframe: Baseline up to Week 48 (End of Study)

Population: Safety Analysis Set - for a subset of treated participants with a valid measurement

To assess immunogenicity of brolucizumab 6 mg.

Outcome measures

Measure	Brolucizumab 6 mg n=197 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Anti-drug Antibody (ADA): Frequency Distribution of Integrated ADA Status in the Brolucizumab Arm ADA negative or ADA positive with no boost	170 Participants	—
Anti-drug Antibody (ADA): Frequency Distribution of Integrated ADA Status in the Brolucizumab Arm Induced or Boosted	27 Participants	—

SECONDARY outcome

Timeframe: Day 1, Day 2, Day 8, Day 15, Day 22, and Day 29

Population: Safety Analysis Set - for a subset of participants with a valid measurement

The maximum (peak) observed serum drug concentration after single dose administration (mass x volume-1)

Outcome measures

Measure	Brolucizumab 6 mg n=13 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Pharmacokinetic Parameters: Cmax After First Brolucizumab 6 mg Dose in a Subset of Subjects	39.7 ng/mL Geometric Coefficient of Variation 121.0	—

SECONDARY outcome

Timeframe: Day 1, Day 2, Day 8, Day 15, Day 22, and Day 29

Population: Safety Analysis Set - for a subset of participants with a valid measurement

The time to reach maximum (peak) serum drug concentration after single dose administration (time).

Actual sampling times were taken into consideration for the pharmacokinetic (PK) analysis.

Outcome measures

Measure	Brolucizumab 6 mg n=13 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Pharmacokinetic Parameters: Tmax After First Brolucizumab 6 mg Dose in a Subset of Subjects	5.25 hour Interval 5.03 to 20.3	—

SECONDARY outcome

Timeframe: Day 1, Day 2, Day 8, Day 15, Day 22, and Day 29

Population: Safety Analysis Set - for a subset of treated participants with a valid measurement

The AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1)

Outcome measures

Measure	Brolucizumab 6 mg n=13 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Pharmacokinetic Parameters: AUClast After First Brolucizumab 6 mg Dose in a Subset of Subjects	2690 h*ng/mL Geometric Coefficient of Variation 74.4	—

SECONDARY outcome

Timeframe: Day 1, Day 2, Day 8, Day 15, Day 22, and Day 29

Population: Safety Analysis Set - for a subset of treated participants with a valid measurement

The AUC from time zero to infinity (mass x time x volume-1)

Outcome measures

Measure	Brolucizumab 6 mg n=11 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Pharmacokinetic Parameters: AUCinf After First Brolucizumab 6 mg Dose in a Subset of Subjects	3100 h*ng/mL Geometric Coefficient of Variation 73.4	—

SECONDARY outcome

Timeframe: Day 1, Day 2, Day 8, Day 15, Day 22, and Day 29

Population: Safety Analysis Set - for a subset of treated participants with a valid measurement

The elimination half-life associated with the terminal slope (lz) of a semi logarithmic concentration time curve (time).

Outcome measures

Measure	Brolucizumab 6 mg n=11 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Pharmacokinetic Parameters: T1/2 After First Brolucizumab 6 mg Dose in a Subset of Subjects	110 hours Geometric Coefficient of Variation 37.9	—

SECONDARY outcome

Timeframe: Day 1, Day 2, Day 8, Day 15, Day 22, and Day 29

Population: Safety Analysis Set - for a subset of treated participants

Apparent total body clearance of siremadlin from serum (CL/F)

Outcome measures

Measure	Brolucizumab 6 mg n=11 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Pharmacokinetic Parameters: CL/F After First Brolucizumab 6 mg Dose in a Subset of Subjects	1.93 Liters/hour Geometric Coefficient of Variation 73.4	—

SECONDARY outcome

Timeframe: Day 1, Day 2, Day 8, Day 15, Day 22, and Day 29

Population: Safety Analysis Set - for a subset of treated participants with a valid measurement

Apparent volume of distribution during terminal elimination phase (Vz/F)

Outcome measures

Measure	Brolucizumab 6 mg n=11 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Pharmacokinetic Parameters: Vz/F After First Brolucizumab 6 mg Dose in a Subset of Subjects	307 L Geometric Coefficient of Variation 48.6	—

SECONDARY outcome

Timeframe: Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks

Population: Safety Analysis Set

An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject.

Treatment-emergent AEs are presented, which are AEs that developed on or after first study treatment administration, or any event previously present that worsened following exposure to the study treatment.

Outcome measures

Measure	Brolucizumab 6 mg n=199 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg n=198 Participants 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Most Common Ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term for the Study Eye Number of participants with at least one AE	58 Participants	48 Participants
Most Common Ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term for the Study Eye Intraocular pressure increased	10 Participants	6 Participants
Most Common Ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term for the Study Eye Conjunctival haemorrhage	7 Participants	3 Participants
Most Common Ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term for the Study Eye Visual acuity reduced	7 Participants	2 Participants
Most Common Ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term for the Study Eye Retinal haemorrhage	6 Participants	4 Participants
Most Common Ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term for the Study Eye Uveitis	6 Participants	0 Participants
Most Common Ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term for the Study Eye Conjunctivitis	5 Participants	4 Participants
Most Common Ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term for the Study Eye Dry eye	5 Participants	3 Participants
Most Common Ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term for the Study Eye Cataract	4 Participants	8 Participants
Most Common Ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term for the Study Eye Meibomian gland dysfunction	4 Participants	7 Participants
Most Common Ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term for the Study Eye Xerophthalmia	4 Participants	2 Participants

SECONDARY outcome

Timeframe: Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks

Population: Safety Analysis Set

An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject.

Treatment-emergent AEs are counted, which are AEs that developed on or after first study treatment administration, or any event previously present that worsened following exposure to the study treatment.

Outcome measures

Measure	Brolucizumab 6 mg n=199 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg n=198 Participants 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Non-ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm)	97 Participants	113 Participants

POST_HOC outcome

Timeframe: Deaths are reported from first dose of study treatment until approximately Day 185.

Population: Safety Set

On-treatment deaths are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks.

Post-treatment deaths are reported 30 days after last treatment to 72 days post treatment (Day 185).

Outcome measures

Measure	Brolucizumab 6 mg n=199 Participants 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2 mg n=198 Participants 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
All Collected Deaths On-treatment Deaths	0 Participants	0 Participants
All Collected Deaths Post-treatment Deaths	0 Participants	1 Participants
All Collected Deaths Total Deaths	0 Participants	1 Participants

Adverse Events

Brolucizumab 6mg

Serious events: 23 serious events

Other events: 94 other events

Deaths: 0 deaths

Aflibercept 2mg

Serious events: 24 serious events

Other events: 90 other events

Deaths: 1 deaths

Overall

Serious events: 47 serious events

Other events: 184 other events

Deaths: 1 deaths

Serious adverse events

Measure	Brolucizumab 6mg n=199 participants at risk 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2mg n=198 participants at risk 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.	Overall n=397 participants at risk Overall
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.50% 1/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	1.0% 2/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.76% 3/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Cardiac disorders Myocardial infarction	0.00% 0/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.51% 1/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.25% 1/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Congenital, familial and genetic disorders Atrial septal defect	0.50% 1/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.00% 0/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.25% 1/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Eye disorders Cataract - Fellow eye	0.50% 1/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.00% 0/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.25% 1/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.51% 1/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.25% 1/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Cardiac disorders Coronary artery disease	0.50% 1/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.00% 0/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.25% 1/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Eye disorders Cataract - Study eye	0.50% 1/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.00% 0/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.25% 1/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Eye disorders Iridodialysis - Study eye	0.50% 1/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.00% 0/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.25% 1/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Eye disorders Neovascular age-related macular degeneration - Fellow eye	0.50% 1/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.00% 0/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.25% 1/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Eye disorders Vitreous haemorrhage - Fellow eye	0.00% 0/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.51% 1/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.25% 1/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Eye disorders Vitreous haemorrhage - Study eye	0.50% 1/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.00% 0/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.25% 1/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Gastrointestinal disorders Inguinal hernia	0.00% 0/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.51% 1/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.25% 1/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Gastrointestinal disorders Intestinal obstruction	0.50% 1/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.00% 0/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.25% 1/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Gastrointestinal disorders Large intestine polyp	1.0% 2/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.00% 0/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.50% 2/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Hepatobiliary disorders Bile duct stone	0.00% 0/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.51% 1/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.25% 1/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Hepatobiliary disorders Cholecystitis chronic	0.50% 1/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.00% 0/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.25% 1/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Hepatobiliary disorders Cholelithiasis	0.50% 1/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.00% 0/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.25% 1/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Hepatobiliary disorders Hepatic cirrhosis	0.50% 1/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.00% 0/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.25% 1/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Infections and infestations Appendicitis	0.50% 1/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.00% 0/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.25% 1/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Infections and infestations COVID-19	0.50% 1/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.51% 1/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.50% 2/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Infections and infestations Lower respiratory tract infection	0.00% 0/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.51% 1/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.25% 1/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Infections and infestations Pneumonia	1.0% 2/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.00% 0/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.50% 2/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Infections and infestations Pulmonary tuberculosis	0.50% 1/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.00% 0/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.25% 1/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Infections and infestations Tuberculosis	0.50% 1/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.00% 0/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.25% 1/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Injury, poisoning and procedural complications Concussion	0.50% 1/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.00% 0/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.25% 1/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Injury, poisoning and procedural complications Corneal laceration - Study eye	0.50% 1/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.00% 0/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.25% 1/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.51% 1/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.25% 1/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Injury, poisoning and procedural complications Rib fracture	0.50% 1/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.00% 0/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.25% 1/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.51% 1/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.25% 1/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.50% 1/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.00% 0/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.25% 1/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.50% 1/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.00% 0/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.25% 1/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.00% 0/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.51% 1/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.25% 1/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer metastatic	0.50% 1/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.00% 0/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.25% 1/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant mesenteric neoplasm	0.50% 1/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.00% 0/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.25% 1/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.00% 0/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.51% 1/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.25% 1/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Nervous system disorders Carotid artery stenosis	0.00% 0/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.51% 1/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.25% 1/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Nervous system disorders Cerebral haemorrhage	0.50% 1/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.51% 1/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.50% 2/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Nervous system disorders Cerebral infarction	1.0% 2/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	1.0% 2/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	1.0% 4/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Nervous system disorders Lacunar infarction	1.0% 2/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.51% 1/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.76% 3/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Nervous system disorders Thalamic infarction	0.00% 0/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.51% 1/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.25% 1/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Nervous system disorders Vertebrobasilar insufficiency	0.50% 1/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.51% 1/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.50% 2/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Product Issues Device breakage	0.00% 0/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.51% 1/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.25% 1/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Renal and urinary disorders Nephrolithiasis	0.00% 0/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.51% 1/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.25% 1/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	1.0% 2/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.50% 2/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Vascular disorders Hypertension	0.50% 1/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.00% 0/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.25% 1/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Vascular disorders Varicose vein	0.00% 0/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.51% 1/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.25% 1/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.

Other adverse events

Measure	Brolucizumab 6mg n=199 participants at risk 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.	Aflibercept 2mg n=198 participants at risk 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.	Overall n=397 participants at risk Overall
Cardiac disorders Arteriosclerosis coronary artery	2.5% 5/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.51% 1/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	1.5% 6/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Endocrine disorders Thyroid mass	2.0% 4/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.00% 0/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	1.0% 4/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Eye disorders Cataract - Fellow eye	1.0% 2/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	2.5% 5/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	1.8% 7/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Eye disorders Cataract - Study eye	1.5% 3/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	4.0% 8/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	2.8% 11/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Eye disorders Conjunctival haemorrhage - Study eye	3.5% 7/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	1.5% 3/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	2.5% 10/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Eye disorders Dry eye - Fellow eye	2.5% 5/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	2.0% 4/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	2.3% 9/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Eye disorders Dry eye - Study eye	2.5% 5/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	1.5% 3/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	2.0% 8/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Eye disorders Meibomian gland dysfunction - Fellow eye	2.0% 4/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	3.0% 6/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	2.5% 10/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Eye disorders Meibomian gland dysfunction - Study eye	2.0% 4/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	3.5% 7/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	2.8% 11/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Eye disorders Neovascular age-related macular degeneration - Fellow eye	0.50% 1/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	3.5% 7/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	2.0% 8/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Eye disorders Retinal haemorrhage - Study eye	3.0% 6/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	2.0% 4/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	2.5% 10/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Eye disorders Uveitis - Study eye	3.0% 6/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.00% 0/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	1.5% 6/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Eye disorders Visual acuity reduced - Study eye	3.5% 7/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	1.0% 2/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	2.3% 9/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Eye disorders Xerophthalmia - Fellow eye	2.0% 4/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	1.0% 2/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	1.5% 6/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Eye disorders Xerophthalmia - Study eye	2.0% 4/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	1.0% 2/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	1.5% 6/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
General disorders Pyrexia	4.0% 8/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	3.5% 7/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	3.8% 15/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Infections and infestations COVID-19	11.1% 22/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	13.1% 26/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	12.1% 48/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Infections and infestations Conjunctivitis - Study eye	2.5% 5/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	2.0% 4/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	2.3% 9/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Infections and infestations Pneumonia	2.5% 5/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	2.0% 4/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	2.3% 9/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Infections and infestations Upper respiratory tract infection	7.5% 15/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	7.1% 14/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	7.3% 29/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Infections and infestations Urinary tract infection	0.00% 0/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	2.5% 5/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	1.3% 5/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Investigations Blood urea nitrogen/creatinine ratio increased	2.0% 4/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	1.5% 3/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	1.8% 7/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Investigations Intraocular pressure increased - Fellow eye	1.5% 3/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	2.5% 5/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	2.0% 8/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Investigations Intraocular pressure increased - Study eye	5.0% 10/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	3.0% 6/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	4.0% 16/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Metabolism and nutrition disorders Hyperuricaemia	2.0% 4/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	2.5% 5/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	2.3% 9/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Metabolism and nutrition disorders Hypokalaemia	2.0% 4/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	1.0% 2/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	1.5% 6/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Renal and urinary disorders Renal cyst	2.0% 4/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	1.5% 3/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	1.8% 7/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Respiratory, thoracic and mediastinal disorders Cough	2.5% 5/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	3.0% 6/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	2.8% 11/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Vascular disorders Aortic arteriosclerosis	2.0% 4/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	0.51% 1/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	1.3% 5/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.
Vascular disorders Hypertension	3.0% 6/199 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	2.0% 4/198 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.	2.5% 10/397 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Deaths are reported from first dose of study treatment until approximately Day 185.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: + 1 862 778 8300

Email: Novartis.email@Novartis.com

Results disclosure agreements

• Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
• Publication restrictions are in place

Restriction type: OTHER