Study of Efficacy and Safety of Brolucizumab vs. Afliberc... | NCT04047472

Label	Type	Description	Intervention Names
Brolucizumab 6 mg	Experimental	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.	Drug: Brolucizumab 6mg
Aflibercept 2 mg	Active Comparator	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.	Drug: Aflibercept 2 mg

Name	Type	Description	Arm Group Labels	Other Names
Brolucizumab 6mg	Drug	Intravitreal injection	Brolucizumab 6 mg	Beovu

Measure	Description	Time Frame
Change From Baseline at Week 48 in Best-Corrected Visual Acuity in Study Eye	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.	Baseline, Week 48

Measure	Description	Time Frame
Average Change From Baseline Over the Period of Week 36 to Week 48 in Best-Corrected Visual Acuity in Study Eye	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.

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Beijing	Beijing Municipality	100044	China
Novartis Investigative Site

ID	Title	Description
FG000	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.
FG001	Aflibercept 2 mg

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 14, 2022	Oct 18, 2024

Primary

Change From Baseline at Week 48 in Best-Corrected Visual Acuity in Study Eye

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.

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

Posted

Least Squares Mean

Standard Error

Letters Read

Baseline, Week 48

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000199 OG001198

Title

Denominators

Categories

Title	Measurements
	OG0009.9± 0.82 OG00110.9± 0.82

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANOVA		0.006		LS mean difference	-1.1	Standard Error of the Mean	1.16	2-Sided	90	-3.0	0.9					Non-Inferiority	Non-inferiority of brolucizumab to aflibercept with respect to change from baseline in BCVA, considering a margin of 4 letters.

Secondary

Average Change From Baseline Over the Period of Week 36 to Week 48 in Best-Corrected Visual Acuity in Study Eye

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.

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

Posted

Least Squares Mean

Standard Error

Letters Read

Baseline, over the period Week 36 to Week 48

ID	Title	Description
OG000	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.
OG001	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.

Secondary

q12w Treatment Status at Week 48 (for Subjects Randomized to Brolucizumab 6 mg Only) - Probability

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).

Full Analysis Set (FAS)

Posted

Number

90% Confidence Interval

Probability of no q8w-need

Week 44

ID	Title	Description
OG000	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.

Units	Counts
Participants

Secondary

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

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.

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

Posted

Number

90% Confidence Interval

Probability of no q8w-need

Week 44

ID	Title	Description
OG000	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.

Units	Counts
Participants

Secondary

Number (%) of Participants With q8w Treatment Need as Assessed by the Investigator at First Disease Activity Assessment (DAA) Visit

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.

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

Posted

Count of Participants

Participants

Week 16

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts

Secondary

Change From Baseline at Each Study Visit in Best-Corrected Visual Acuity in Study Eye

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.

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

Posted

Least Squares Mean

Standard Error

Letters Read

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

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

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.

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

Posted

Least Squares Mean

Standard Error

Letters Read

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Number of Subjects With Best-Corrected Visual Acuity of 73 Letters or More at Each Visit

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.

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

Posted

Count of Participants

Participants

Baseline up to Week 48

ID	Title	Description
OG000	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.
OG001	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.

Secondary

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

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.

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

Posted

Count of Participants

Participants

Baseline up to Week 48

ID	Title	Description
OG000	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.
OG001	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.

Secondary

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

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.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

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

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.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

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

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.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

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

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.

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

Posted

Count of Participants

Participants

Baseline, Week 48

ID	Title	Description
OG000	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.
OG001	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.

Secondary

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

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.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

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

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.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

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

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.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Average Change From Baseline Over the Period Week 4 Through Week 48 in Central Subfield Thickness - Total in Study Eye

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.

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

Posted

Least Squares Mean

Standard Error

μm

Baseline, over the period Week 4 through Week 48

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Average Change From Baseline Over the Period Week 36 Through 48 in Central Subfield Thickness - Total in Study Eye

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.

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

Posted

Least Squares Mean

Standard Error

μm

Baseline, over the period Week 36 to Week 48

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Change From Baseline at Each Study Visit in Central Subfield Thickness - Total in Study Eye

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.

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

Posted

Least Squares Mean

Standard Error

μm

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Change From Baseline at Each Study Visit in Central Subfield Thickness - Neurosensory Retina (μm) in Study Eye

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.

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

Posted

Least Squares Mean

Standard Error

μm

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

ID	Title	Description
OG000	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.
OG001	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.

Units

Secondary

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)

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Secondary

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

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

Posted

Count of Participants

Participants

Between Weeks 36 and Weeks 48

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Secondary

Subretinal Fluid (SRF) Status in the Central Subfield: Number of Subjects With Presence of SRF by Visit for the Study Eye

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Secondary

Intraretinal Fluid (IRF) Status in the Central Subfield: Number of Subjects With Presence of IRF by Visit for the Study Eye

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Secondary

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

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Secondary

Change From Baseline at Weeks 12 and 48 in Choroidal Neovascularization (CNV) Lesion in Study Eye

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

Posted

Least Squares Mean

Standard Error

mm^2

Baseline, Week 12 and Week 48

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Secondary

Number of Subjects With Presence of Fibrosis (Central Subfield) in the Study Eye by Visit

As assessed by color fundus photography.

Safety Analysis Set

Posted

Count of Participants

Participants

Baseline, Week 12, Week 48

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Secondary

Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Composite Score

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.

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

Posted

Mean

Standard Deviation

Scores on a Scale

Baseline, Week 24 and Week 48

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - General Vision

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.

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

Posted

Mean

Standard Deviation

Scores on a Scale

Baseline, Week 24 and Week 48

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Ocular Pain

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.

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

Posted

Mean

Standard Deviation

Scores on a Scale

Baseline, Week 24 and Week 48

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Near Activities

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.

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

Posted

Mean

Standard Deviation

Scores on a Scale

Baseline, Week 24 and Week 48

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Distance Activities

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.

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

Posted

Mean

Standard Deviation

Scores on a Scale

Baseline, Week 24 and Week 48

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Social Functioning

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.

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

Posted

Mean

Standard Deviation

Scores on a Scale

Baseline, Week 24 and Week 48

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Mental Health

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.

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

Posted

Mean

Standard Deviation

Scores on a Scale

Baseline, Week 24 and Week 48

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Role Difficulties

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.

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

Posted

Mean

Standard Deviation

Scores on a Scale

Baseline, Week 24 and Week 48

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Dependency

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.

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

Posted

Mean

Standard Deviation

Scores on a Scale

Baseline, Week 24 and Week 48

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Driving

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.

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

Posted

Mean

Standard Deviation

Scores on a Scale

Baseline, Week 24 and Week 48

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Color Vision

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.

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

Posted

Mean

Standard Deviation

Scores on a Scale

Baseline, Week 24 and Week 48

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Peripheral Vision

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.

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

Posted

Mean

Standard Deviation

Scores on a Scale

Baseline, Week 24 and Week 48

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - General Health Rating

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.

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

Posted

Mean

Standard Deviation

Scores on a Scale

Baseline, Week 24 and Week 48

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Anti-drug Antibody (ADA): Frequency Distribution of Pre-dose ADA Status in the Brolucizumab Arm

To assess immunogenicity of brolucizumab 6 mg.

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

Posted

Count of Participants

Participants

Baseline

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Secondary

Anti-drug Antibody (ADA): Frequency Distribution of Integrated ADA Status in the Brolucizumab Arm

To assess immunogenicity of brolucizumab 6 mg.

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

Posted

Count of Participants

Participants

Baseline up to Week 48 (End of Study)

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Secondary

Pharmacokinetic Parameters: Cmax After First Brolucizumab 6 mg Dose in a Subset of Subjects

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

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

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

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

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Secondary

Pharmacokinetic Parameters: Tmax After First Brolucizumab 6 mg Dose in a Subset of Subjects

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.

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

Posted

Median

Full Range

hour

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

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Secondary

Pharmacokinetic Parameters: AUClast After First Brolucizumab 6 mg Dose in a Subset of Subjects

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

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

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ng/mL

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

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Secondary

Pharmacokinetic Parameters: AUCinf After First Brolucizumab 6 mg Dose in a Subset of Subjects

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

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

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ng/mL

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

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Secondary

Pharmacokinetic Parameters: T1/2 After First Brolucizumab 6 mg Dose in a Subset of Subjects

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

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

Posted

Geometric Mean

Geometric Coefficient of Variation

hours

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

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Secondary

Pharmacokinetic Parameters: CL/F After First Brolucizumab 6 mg Dose in a Subset of Subjects

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

Safety Analysis Set - for a subset of treated participants

Posted

Geometric Mean

Geometric Coefficient of Variation

Liters/hour

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

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Secondary

Pharmacokinetic Parameters: Vz/F After First Brolucizumab 6 mg Dose in a Subset of Subjects

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

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

Posted

Geometric Mean

Geometric Coefficient of Variation

L

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

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Secondary

Most Common Ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term for the Study Eye

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.

Safety Analysis Set

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Non-ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm)

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.

Safety Analysis Set

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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.
OG001	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.

Post-Hoc

All Collected Deaths

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).

Safety Set

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Brolucizumab 6mg	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.	0	199	23	199	94	199
EG001	Aflibercept 2mg	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.	1	198	24	198	90	198
EG002	Overall	Overall	1	397	47	397	184	397

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Thrombocytosis	Blood and lymphatic system disorders	MedDRA (26.1)	Systematic Assessment	EG0000 affected199 at risk EG0011 affected198 at risk EG0021 affected397 at risk
Coronary artery disease	Cardiac disorders	MedDRA (26.1)	Systematic Assessment	EG0001 affected199 at risk EG0010 affected198 at risk EG0021 affected397 at risk
Myocardial infarction	Cardiac disorders	MedDRA (26.1)	Systematic Assessment	EG0000 affected199 at risk EG0011 affected198 at risk EG0021 affected397 at risk
Atrial septal defect	Congenital, familial and genetic disorders	MedDRA (26.1)	Systematic Assessment	EG0001 affected199 at risk EG0010 affected198 at risk EG0021 affected397 at risk
Cataract - Fellow eye	Eye disorders	MedDRA (26.1)	Systematic Assessment	EG0001 affected199 at risk EG0010 affected198 at risk EG0021 affected397 at risk
Cataract - Study eye	Eye disorders	MedDRA (26.1)	Systematic Assessment	EG0001 affected199 at risk EG0010 affected198 at risk EG0021 affected397 at risk
Iridodialysis - Study eye	Eye disorders	MedDRA (26.1)	Systematic Assessment	EG0001 affected199 at risk EG0010 affected198 at risk EG0021 affected397 at risk
Neovascular age-related macular degeneration - Fellow eye	Eye disorders	MedDRA (26.1)	Systematic Assessment	EG0001 affected199 at risk EG0010 affected198 at risk EG0021 affected397 at risk
Vitreous haemorrhage - Fellow eye	Eye disorders	MedDRA (26.1)	Systematic Assessment	EG0000 affected199 at risk EG0011 affected198 at risk EG0021 affected397 at risk
Vitreous haemorrhage - Study eye	Eye disorders	MedDRA (26.1)	Systematic Assessment	EG0001 affected199 at risk EG0010 affected198 at risk EG0021 affected397 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (26.1)	Systematic Assessment	EG0000 affected199 at risk EG0011 affected198 at risk EG0021 affected397 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (26.1)	Systematic Assessment	EG0001 affected199 at risk EG0010 affected198 at risk EG0021 affected397 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA (26.1)	Systematic Assessment	EG0002 affected199 at risk EG0010 affected198 at risk EG0022 affected397 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA (26.1)	Systematic Assessment	EG0000 affected199 at risk EG0011 affected198 at risk EG0021 affected397 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA (26.1)	Systematic Assessment	EG0001 affected199 at risk EG0010 affected198 at risk EG0021 affected397 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (26.1)	Systematic Assessment	EG0001 affected199 at risk EG0010 affected198 at risk EG0021 affected397 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA (26.1)	Systematic Assessment	EG0001 affected199 at risk EG0010 affected198 at risk EG0021 affected397 at risk
Appendicitis	Infections and infestations	MedDRA (26.1)	Systematic Assessment	EG0001 affected199 at risk EG0010 affected198 at risk EG0021 affected397 at risk
COVID-19	Infections and infestations	MedDRA (26.1)	Systematic Assessment	EG0001 affected199 at risk EG0011 affected198 at risk EG0022 affected397 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA (26.1)	Systematic Assessment	EG0000 affected199 at risk EG0011 affected198 at risk EG0021 affected397 at risk
Pneumonia	Infections and infestations	MedDRA (26.1)	Systematic Assessment	EG0002 affected199 at risk EG0010 affected198 at risk EG0022 affected397 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA (26.1)	Systematic Assessment	EG0001 affected199 at risk EG0010 affected198 at risk EG0021 affected397 at risk
Tuberculosis	Infections and infestations	MedDRA (26.1)	Systematic Assessment	EG0001 affected199 at risk EG0010 affected198 at risk EG0021 affected397 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA (26.1)	Systematic Assessment	EG0001 affected199 at risk EG0010 affected198 at risk EG0021 affected397 at risk
Corneal laceration - Study eye	Injury, poisoning and procedural complications	MedDRA (26.1)	Systematic Assessment	EG0001 affected199 at risk EG0010 affected198 at risk EG0021 affected397 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA (26.1)	Systematic Assessment	EG0000 affected199 at risk EG0011 affected198 at risk EG0021 affected397 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA (26.1)	Systematic Assessment	EG0001 affected199 at risk EG0010 affected198 at risk EG0021 affected397 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA (26.1)	Systematic Assessment	EG0000 affected199 at risk EG0011 affected198 at risk EG0021 affected397 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA (26.1)	Systematic Assessment	EG0001 affected199 at risk EG0010 affected198 at risk EG0021 affected397 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Systematic Assessment	EG0001 affected199 at risk EG0010 affected198 at risk EG0021 affected397 at risk
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Systematic Assessment	EG0000 affected199 at risk EG0011 affected198 at risk EG0021 affected397 at risk
Hepatic cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Systematic Assessment	EG0001 affected199 at risk EG0010 affected198 at risk EG0021 affected397 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Systematic Assessment	EG0001 affected199 at risk EG0012 affected198 at risk EG0023 affected397 at risk
Malignant mesenteric neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Systematic Assessment	EG0001 affected199 at risk EG0010 affected198 at risk EG0021 affected397 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.1)	Systematic Assessment	EG0000 affected199 at risk EG0011 affected198 at risk EG0021 affected397 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA (26.1)	Systematic Assessment	EG0000 affected199 at risk EG0011 affected198 at risk EG0021 affected397 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA (26.1)	Systematic Assessment	EG0001 affected199 at risk EG0011 affected198 at risk EG0022 affected397 at risk
Cerebral infarction	Nervous system disorders	MedDRA (26.1)	Systematic Assessment	EG0002 affected199 at risk EG0012 affected198 at risk EG0024 affected397 at risk
Lacunar infarction	Nervous system disorders	MedDRA (26.1)	Systematic Assessment	EG0002 affected199 at risk EG0011 affected198 at risk EG0023 affected397 at risk
Thalamic infarction	Nervous system disorders	MedDRA (26.1)	Systematic Assessment	EG0000 affected199 at risk EG0011 affected198 at risk EG0021 affected397 at risk
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA (26.1)	Systematic Assessment	EG0001 affected199 at risk EG0011 affected198 at risk EG0022 affected397 at risk
Device breakage	Product Issues	MedDRA (26.1)	Systematic Assessment	EG0000 affected199 at risk EG0011 affected198 at risk EG0021 affected397 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (26.1)	Systematic Assessment	EG0000 affected199 at risk EG0011 affected198 at risk EG0021 affected397 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (26.1)	Systematic Assessment	EG0000 affected199 at risk EG0012 affected198 at risk EG0022 affected397 at risk
Hypertension	Vascular disorders	MedDRA (26.1)	Systematic Assessment	EG0001 affected199 at risk EG0010 affected198 at risk EG0021 affected397 at risk
Varicose vein	Vascular disorders	MedDRA (26.1)	Systematic Assessment	EG0000 affected199 at risk EG0011 affected198 at risk EG0021 affected397 at risk

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA (26.1)	Systematic Assessment	EG0005 affected199 at risk EG0011 affected198 at risk EG0026 affected397 at risk
Thyroid mass	Endocrine disorders	MedDRA (26.1)	Systematic Assessment	EG0004 affected199 at risk EG0010 affected198 at risk EG0024 affected397 at risk
Cataract - Fellow eye	Eye disorders	MedDRA (26.1)	Systematic Assessment	EG0002 affected199 at risk EG0015 affected198 at risk EG0027 affected397 at risk
Cataract - Study eye	Eye disorders	MedDRA (26.1)	Systematic Assessment	EG0003 affected199 at risk EG0018 affected198 at risk EG00211 affected397 at risk
Conjunctival haemorrhage - Study eye	Eye disorders	MedDRA (26.1)	Systematic Assessment	EG0007 affected199 at risk EG0013 affected198 at risk EG00210 affected397 at risk
Dry eye - Fellow eye	Eye disorders	MedDRA (26.1)	Systematic Assessment	EG0005 affected199 at risk EG0014 affected198 at risk EG0029 affected397 at risk
Dry eye - Study eye	Eye disorders	MedDRA (26.1)	Systematic Assessment	EG0005 affected199 at risk EG0013 affected198 at risk EG0028 affected397 at risk
Meibomian gland dysfunction - Fellow eye	Eye disorders	MedDRA (26.1)	Systematic Assessment	EG0004 affected199 at risk EG0016 affected198 at risk EG00210 affected397 at risk
Meibomian gland dysfunction - Study eye	Eye disorders	MedDRA (26.1)	Systematic Assessment	EG0004 affected199 at risk EG0017 affected198 at risk EG00211 affected397 at risk
Neovascular age-related macular degeneration - Fellow eye	Eye disorders	MedDRA (26.1)	Systematic Assessment	EG0001 affected199 at risk EG0017 affected198 at risk EG0028 affected397 at risk
Retinal haemorrhage - Study eye	Eye disorders	MedDRA (26.1)	Systematic Assessment	EG0006 affected199 at risk EG0014 affected198 at risk EG00210 affected397 at risk
Uveitis - Study eye	Eye disorders	MedDRA (26.1)	Systematic Assessment	EG0006 affected199 at risk EG0010 affected198 at risk EG0026 affected397 at risk
Visual acuity reduced - Study eye	Eye disorders	MedDRA (26.1)	Systematic Assessment	EG0007 affected199 at risk EG0012 affected198 at risk EG0029 affected397 at risk
Xerophthalmia - Fellow eye	Eye disorders	MedDRA (26.1)	Systematic Assessment	EG0004 affected199 at risk EG0012 affected198 at risk EG0026 affected397 at risk
Xerophthalmia - Study eye	Eye disorders	MedDRA (26.1)	Systematic Assessment	EG0004 affected199 at risk EG0012 affected198 at risk EG0026 affected397 at risk
Pyrexia	General disorders	MedDRA (26.1)	Systematic Assessment	EG0008 affected199 at risk EG0017 affected198 at risk EG00215 affected397 at risk
COVID-19	Infections and infestations	MedDRA (26.1)	Systematic Assessment	EG00022 affected199 at risk EG00126 affected198 at risk EG00248 affected397 at risk
Conjunctivitis - Study eye	Infections and infestations	MedDRA (26.1)	Systematic Assessment	EG0005 affected199 at risk EG0014 affected198 at risk EG0029 affected397 at risk
Pneumonia	Infections and infestations	MedDRA (26.1)	Systematic Assessment	EG0005 affected199 at risk EG0014 affected198 at risk EG0029 affected397 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (26.1)	Systematic Assessment	EG00015 affected199 at risk EG00114 affected198 at risk EG00229 affected397 at risk
Urinary tract infection	Infections and infestations	MedDRA (26.1)	Systematic Assessment	EG0000 affected199 at risk EG0015 affected198 at risk EG0025 affected397 at risk
Blood urea nitrogen/creatinine ratio increased	Investigations	MedDRA (26.1)	Systematic Assessment	EG0004 affected199 at risk EG0013 affected198 at risk EG0027 affected397 at risk
Intraocular pressure increased - Fellow eye	Investigations	MedDRA (26.1)	Systematic Assessment	EG0003 affected199 at risk EG0015 affected198 at risk EG0028 affected397 at risk
Intraocular pressure increased - Study eye	Investigations	MedDRA (26.1)	Systematic Assessment	EG00010 affected199 at risk EG0016 affected198 at risk EG00216 affected397 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA (26.1)	Systematic Assessment	EG0004 affected199 at risk EG0015 affected198 at risk EG0029 affected397 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (26.1)	Systematic Assessment	EG0004 affected199 at risk EG0012 affected198 at risk EG0026 affected397 at risk
Renal cyst	Renal and urinary disorders	MedDRA (26.1)	Systematic Assessment	EG0004 affected199 at risk EG0013 affected198 at risk EG0027 affected397 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (26.1)	Systematic Assessment	EG0005 affected199 at risk EG0016 affected198 at risk EG00211 affected397 at risk
Aortic arteriosclerosis	Vascular disorders	MedDRA (26.1)	Systematic Assessment	EG0004 affected199 at risk EG0011 affected198 at risk EG0025 affected397 at risk
Hypertension	Vascular disorders	MedDRA (26.1)	Systematic Assessment	EG0006 affected199 at risk EG0014 affected198 at risk EG00210 affected397 at risk

ID	Term
D008268	Macular Degeneration
D014786	Vision Disorders
D057135	Wet Macular Degeneration

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases
D012678	Sensation Disorders
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups