Trial Outcomes & Findings for Study of Innovative Multimodal Imaging Biomarkers to Predict Anatomical Outcome in Naive Patients With wAMD Treated With Brolucizumab. (NCT NCT04774926)

Last Updated: 2025-05-16

Results Overview

Early predictive factors of fluid-free response is defined as the absence of retinal fluid at Week 48 in patients with a stable q12w treatment regimen up to Week 48 after the loading phase, As assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). q12w fluid-free: pts completing the treatment and the study maintaining a stable q12w regimen assigned at Wk 16 up to Wk 48 and without the presence of IRF and SRF at Wk 48. not q12w fluid-free: * Pt who completed treatment and the study with the presence of IRF or SRF at Wk 48 * Pt who followed the q8w regimen of treatment at any time during the study (considering also who started with q12w regimen but then due to disease activity shifted to q8w regimen) * Pt who discontinued treatment at any time after b/l since treatment disc. was considered as intercurrent event and a 'failure'. * Pt who dropped out at any time after b/l since study disc. was considered as intercurrent event and a 'failure'.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

122 participants

Primary outcome timeframe

Up to Week 48

Results posted on

2025-05-16

Participant Flow

If both eyes were eligible as per the inclusion and exclusion criteria, only one eye was treated during the study, with the eye with the worse visual acuity (BCVA) at Baseline selected as the study eye. If both eyes had the same BCVA, the right eye was chosen as the study eye.

Participant milestones

Participant milestones
Measure	Brolucizumab 6 mg Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Overall Study STARTED	122
Overall Study COMPLETED	91
Overall Study NOT COMPLETED	31

Reasons for withdrawal

Reasons for withdrawal
Measure	Brolucizumab 6 mg Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Overall Study Adverse Event	15
Overall Study Lost to Follow-up	3
Overall Study Physician Decision	6
Overall Study Withdrawal by Subject	3
Overall Study The original PI resigned and a new one could not be appointed	4

Baseline Characteristics

Study of Innovative Multimodal Imaging Biomarkers to Predict Anatomical Outcome in Naive Patients With wAMD Treated With Brolucizumab.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Brolucizumab 6 mg n=122 Participants Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Age, Continuous	76.1 Years STANDARD_DEVIATION 7.88 • n=5 Participants
Sex: Female, Male Female	72 Participants n=5 Participants
Sex: Female, Male Male	50 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	122 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to Week 48

Population: Full Analysis Set - includes all patients who received at least one dose of the study drug and with a valid measurement without a protocol deviation with impact. (Excludes patients with protocol deviations.)

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=120 Participants Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Number of Patients Classified as q12w Fluid-free or Not q12w Fluid-free q12w fluid free - NO	93 Participants
Number of Patients Classified as q12w Fluid-free or Not q12w Fluid-free q12w fluid free - YES	27 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Full Analysis Set - includes all patients who received at least one dose of the study drug and with a valid measurement without a protocol deviation with impact and who were classified as not q12w fluid-free (N=93). (Excludes patients with protocol deviations.)

As assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). Percentages were computed on Safety Population within 'No' and 'Yes' groups according to q12w fluid free. Type 1 neovascularization arises when CNV proliferation occurs below the Retinal Pigment Epithelium (RPE) and corresponds to occult CNV with a poorly defined pattern of leakage on fluorescein angiography (FA). Type 2 neovascularization refers to CNV proliferation above the RPE in the subretinal space and corresponds to classic CNV with intense fluorescein leakage. Type 3 neovascularization (or retinal angiomatous proliferation \[RAP\]) occurs when retinal circulation is involved, with an anastomosis between the choroidal and retinal circulations. Types 1-3 classification is a classification according to the type of anatomical lesion and is determined by multimodal imaging characteristics. Please note that by design, this is not a grading nor scores on a scale. PCV = Polypoidal Choroidal Vasculopathy

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=93 Participants Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Potential Predictor Factors of Fluid-free Response: Type of Predominant Basal Choroidal Neovascularization (CNV) Lesion Type, as Assessed by SD-OCT at Baseline - Patients Classified as Not q12w Fluid-free TYPE I + PCV; q12w fluid free - No	61 Participants
Potential Predictor Factors of Fluid-free Response: Type of Predominant Basal Choroidal Neovascularization (CNV) Lesion Type, as Assessed by SD-OCT at Baseline - Patients Classified as Not q12w Fluid-free TYPE II; q12w fluid free - No	21 Participants
Potential Predictor Factors of Fluid-free Response: Type of Predominant Basal Choroidal Neovascularization (CNV) Lesion Type, as Assessed by SD-OCT at Baseline - Patients Classified as Not q12w Fluid-free TYPE III; q12w fluid free - No	5 Participants
Potential Predictor Factors of Fluid-free Response: Type of Predominant Basal Choroidal Neovascularization (CNV) Lesion Type, as Assessed by SD-OCT at Baseline - Patients Classified as Not q12w Fluid-free Missing; q12w fluid free - No	6 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Full Analysis Set - includes all patients who received at least one dose of the study drug and with a valid measurement without a protocol deviation with impact and who were classified as q12w fluid-free (N=27). (Excludes patients with protocol deviations.)

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=27 Participants Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Potential Predictor Factors of Fluid-free Response: Type of Predominant Basal Choroidal Neovascularization (CNV) Lesion Type, as Assessed by SD-OCT at Baseline - Patients Classified as q12w Fluid-free TYPE I + PCV; q12w fluid free - Yes	19 Participants
Potential Predictor Factors of Fluid-free Response: Type of Predominant Basal Choroidal Neovascularization (CNV) Lesion Type, as Assessed by SD-OCT at Baseline - Patients Classified as q12w Fluid-free TYPE II; q12w fluid free - Yes	4 Participants
Potential Predictor Factors of Fluid-free Response: Type of Predominant Basal Choroidal Neovascularization (CNV) Lesion Type, as Assessed by SD-OCT at Baseline - Patients Classified as q12w Fluid-free TYPE III; q12w fluid free - Yes	3 Participants
Potential Predictor Factors of Fluid-free Response: Type of Predominant Basal Choroidal Neovascularization (CNV) Lesion Type, as Assessed by SD-OCT at Baseline - Patients Classified as q12w Fluid-free Missing; q12w fluid free- Yes	1 Participants

PRIMARY outcome

Timeframe: Baseline to Week 16

As assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). Percentages were computed on Safety Population within 'No' and 'Yes' groups according to q12w fluid free. Of note, the category 'Stable absent' is considered also for cases with baseline and last measurement collected equal to 'No' even if there are at least one 'Yes' in one of the other collected measurements. Similarly, the category 'Stable present' is considered also for cases with baseline and last measurement collected equal to 'Yes' even if there are at least one 'No' in one of the other collected measurements. Stable absent (i.e., all measurements 'No), Stable present (i.e., all measurements 'Yes'), Improved (i.e., last measurement collected as 'No' and baseline 'Yes'), Worsened (i.e., last measurement collected 'Yes' and baseline 'No').

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=93 Participants Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Potential Predictor Factors of Fluid-free Response: Sub-retinal Pigment Epithelium (Sub-RPE) Fluid - Patients Classified as Not q12w Fluid-free Stable absent; q12w fluid free - No	39 Participants
Potential Predictor Factors of Fluid-free Response: Sub-retinal Pigment Epithelium (Sub-RPE) Fluid - Patients Classified as Not q12w Fluid-free Stable present; q12w fluid free - No	32 Participants
Potential Predictor Factors of Fluid-free Response: Sub-retinal Pigment Epithelium (Sub-RPE) Fluid - Patients Classified as Not q12w Fluid-free Improved; q12w fluid free - No	20 Participants
Potential Predictor Factors of Fluid-free Response: Sub-retinal Pigment Epithelium (Sub-RPE) Fluid - Patients Classified as Not q12w Fluid-free Worsened; q12w fluid free - No	2 Participants

PRIMARY outcome

Timeframe: Baseline to Week 16

Population: Full Analysis Set - includes all patients who received at least one dose of the study drug and with a valid measurement without a protocol deviation with impact and who were classified as q12w fluid-free (N=27). (Excludes patients with protocol deviations.)

As assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). Percentages were computed on Safety Population within 'No' and 'Yes' groups according to q12w fluid free. Of note, the category 'Stable absent' is considered also for cases with baseline and last measurement collected equal to 'No' even if there are at least one 'Yes' in one of the other collected measurements. Similarly, the category 'Stable present' is considered also for cases with baseline and last measurement collected equal to 'Yes' even if there are at least one 'No' in one of the other collected measurements. Stable absent (i.e., all measurements 'No), Stable present (i.e., all measurements 'Yes'), Improved (i.e., last measurement collected as 'No' and baseline 'Yes'), Worsened (i.e., last measurement collected 'Yes' and baseline 'No').

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=27 Participants Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Potential Predictor Factors of Fluid-free Response: Sub-retinal Pigment Epithelium (Sub-RPE) Fluid - Patients Classified as q12w Fluid-free Stable absent; q12w fluid free - Yes	12 Participants
Potential Predictor Factors of Fluid-free Response: Sub-retinal Pigment Epithelium (Sub-RPE) Fluid - Patients Classified as q12w Fluid-free Stable present; q12w fluid free - Yes	7 Participants
Potential Predictor Factors of Fluid-free Response: Sub-retinal Pigment Epithelium (Sub-RPE) Fluid - Patients Classified as q12w Fluid-free Improved; q12w fluid free - Yes	8 Participants
Potential Predictor Factors of Fluid-free Response: Sub-retinal Pigment Epithelium (Sub-RPE) Fluid - Patients Classified as q12w Fluid-free Worsened; q12w fluid free - Yes	0 Participants

PRIMARY outcome

Timeframe: Baseline to Week 16

As assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). Percentages were computed on Safety Population within 'No' and 'Yes' groups according to q12w fluid free. Of note, the category 'Stable absent' is considered also for cases with baseline and last measurement collected equal to 'No' even if there are at least one 'Yes' in one of the other collected measurements. Similarly, the category 'Stable present' is considered also for cases with baseline and last measurement collected equal to 'Yes' even if there are at least one 'No' in one of the other collected measurements. Stable absent (i.e., all measurements 'No), Stable present (i.e., all measurements 'Yes'), Improved (i.e., last measurement collected as 'No' and baseline 'Yes'), Worsened (i.e., last measurement collected 'Yes' and baseline 'No').

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=93 Participants Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Potential Predictor Factors of Fluid-free Response: Subretinal Hyperreflective Material (SHRM) - Patients Classified as Not q12w Fluid-free Stable absent; q12w fluid free - No	41 Participants
Potential Predictor Factors of Fluid-free Response: Subretinal Hyperreflective Material (SHRM) - Patients Classified as Not q12w Fluid-free Stable present; q12w fluid free - No	33 Participants
Potential Predictor Factors of Fluid-free Response: Subretinal Hyperreflective Material (SHRM) - Patients Classified as Not q12w Fluid-free Improved; q12w fluid free - No	7 Participants
Potential Predictor Factors of Fluid-free Response: Subretinal Hyperreflective Material (SHRM) - Patients Classified as Not q12w Fluid-free Worsened; q12w fluid free - No	12 Participants

PRIMARY outcome

Timeframe: Baseline to Week 16

Population: Full Analysis Set - includes all patients who received at least one dose of the study drug and with a valid measurement without a protocol deviation with impact and who were classified as q12w fluid-free (N=27). (Excludes patients with protocol deviations.)

As assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). Percentages were computed on Safety Population within 'No' and 'Yes' groups according to q12w fluid free. Of note, the category 'Stable absent' is considered also for cases with baseline and last measurement collected equal to 'No' even if there are at least one 'Yes' in one of the other collected measurements. Similarly, the category 'Stable present' is considered also for cases with baseline and last measurement collected equal to 'Yes' even if there are at least one 'No' in one of the other collected measurements. Stable absent (i.e., all measurements 'No), Stable present (i.e., all measurements 'Yes'), Improved (i.e., last measurement collected as 'No' and baseline 'Yes'), Worsened (i.e., last measurement collected 'Yes' and baseline 'No').

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=27 Participants Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Potential Predictor Factors of Fluid-free Response: Subretinal Hyperreflective Material (SHRM) - Patients Classified as q12w Fluid-free Stable absent; q12w fluid free - Yes	11 Participants
Potential Predictor Factors of Fluid-free Response: Subretinal Hyperreflective Material (SHRM) - Patients Classified as q12w Fluid-free Stable present; q12w fluid free - Yes	7 Participants
Potential Predictor Factors of Fluid-free Response: Subretinal Hyperreflective Material (SHRM) - Patients Classified as q12w Fluid-free Improved; q12w fluid free - Yes	4 Participants
Potential Predictor Factors of Fluid-free Response: Subretinal Hyperreflective Material (SHRM) - Patients Classified as q12w Fluid-free Worsened; q12w fluid free - Yes	5 Participants

PRIMARY outcome

Timeframe: Baseline to Week 16

As assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). Percentages were computed on Safety Population within 'No' and 'Yes' groups according to q12w fluid free. Of note, the category 'Stable absent' is considered also for cases with baseline and last measurement collected equal to 'No' even if there are at least one 'Yes' in one of the other collected measurements. Similarly, the category 'Stable present' is considered also for cases with baseline and last measurement collected equal to 'Yes' even if there are at least one 'No' in one of the other collected measurements. Stable absent (i.e., all measurements 'No), Stable present (i.e., all measurements 'Yes'), Improved (i.e., last measurement collected as 'No' and baseline 'Yes'), Worsened (i.e., last measurement collected 'Yes' and baseline 'No').

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=93 Participants Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Potential Predictor Factors of Fluid-free Response: Outer Retinal Tubulation (ORT) - Patients Classified as Not q12w Fluid-free Stable absent; q12w fluid free - No	84 Participants
Potential Predictor Factors of Fluid-free Response: Outer Retinal Tubulation (ORT) - Patients Classified as Not q12w Fluid-free Stable present; q12w fluid free - No	1 Participants
Potential Predictor Factors of Fluid-free Response: Outer Retinal Tubulation (ORT) - Patients Classified as Not q12w Fluid-free Improved; q12w fluid free - No	3 Participants
Potential Predictor Factors of Fluid-free Response: Outer Retinal Tubulation (ORT) - Patients Classified as Not q12w Fluid-free Worsened; q12w fluid free - No	5 Participants

PRIMARY outcome

Timeframe: Baseline to Week 16

Population: Full Analysis Set - includes all patients who received at least one dose of the study drug and with a valid measurement without a protocol deviation with impact and who were classified as q12w fluid-free (N=27). (Excludes patients with protocol deviations.)

As assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). Percentages were computed on Safety Population within 'No' and 'Yes' groups according to q12w fluid free. Of note, the category 'Stable absent' is considered also for cases with baseline and last measurement collected equal to 'No' even if there are at least one 'Yes' in one of the other collected measurements. Similarly, the category 'Stable present' is considered also for cases with baseline and last measurement collected equal to 'Yes' even if there are at least one 'No' in one of the other collected measurements. Stable absent (i.e., all measurements 'No), Stable present (i.e., all measurements 'Yes'), Improved (i.e., last measurement collected as 'No' and baseline 'Yes'), Worsened (i.e., last measurement collected 'Yes' and baseline 'No').

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=27 Participants Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Potential Predictor Factors of Fluid-free Response: Outer Retinal Tubulation (ORT) - Patients Classified as q12w Fluid-free Stable absent; q12w fluid free - Yes	25 Participants
Potential Predictor Factors of Fluid-free Response: Outer Retinal Tubulation (ORT) - Patients Classified as q12w Fluid-free Stable present; q12w fluid free - Yes	2 Participants
Potential Predictor Factors of Fluid-free Response: Outer Retinal Tubulation (ORT) - Patients Classified as q12w Fluid-free Improved; q12w fluid free - Yes	0 Participants
Potential Predictor Factors of Fluid-free Response: Outer Retinal Tubulation (ORT) - Patients Classified as q12w Fluid-free Worsened; q12w fluid free - Yes	0 Participants

PRIMARY outcome

Timeframe: Baseline to Week 16

As assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). Percentages were computed on Safety Population within 'No' and 'Yes' groups according to q12w fluid free. Of note, the category 'Stable absent' is considered also for cases with baseline and last measurement collected equal to 'No' even if there are at least one 'Yes' in one of the other collected measurements. Similarly, the category 'Stable present' is considered also for cases with baseline and last measurement collected equal to 'Yes' even if there are at least one 'No' in one of the other collected measurements. Stable absent (i.e., all measurements 'No), Stable present (i.e., all measurements 'Yes'), Improved (i.e., last measurement collected as 'No' and baseline 'Yes'), Worsened (i.e., last measurement collected 'Yes' and baseline 'No').

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=93 Participants Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Potential Predictor Factors of Fluid-free Response: External Limiting Membrane (ELM) Integrity Loss in Center 1 mm - Patients Classified as Not q12w Fluid-free Stable absent; q12w fluid free - No	25 Participants
Potential Predictor Factors of Fluid-free Response: External Limiting Membrane (ELM) Integrity Loss in Center 1 mm - Patients Classified as Not q12w Fluid-free Stable present; q12w fluid free- No	43 Participants
Potential Predictor Factors of Fluid-free Response: External Limiting Membrane (ELM) Integrity Loss in Center 1 mm - Patients Classified as Not q12w Fluid-free Improved; q12w fluid free - No	11 Participants
Potential Predictor Factors of Fluid-free Response: External Limiting Membrane (ELM) Integrity Loss in Center 1 mm - Patients Classified as Not q12w Fluid-free Worsened; q12w fluid free - No	14 Participants

PRIMARY outcome

Timeframe: Baseline to Week 16

Population: Full Analysis Set - includes all patients who received at least one dose of the study drug and with a valid measurement without a protocol deviation with impact and who were classified as q12w fluid-free (N=27). (Excludes patients with protocol deviations.)

As assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). Percentages were computed on Safety Population within 'No' and 'Yes' groups according to q12w fluid free. Of note, the category 'Stable absent' is considered also for cases with baseline and last measurement collected equal to 'No' even if there are at least one 'Yes' in one of the other collected measurements. Similarly, the category 'Stable present' is considered also for cases with baseline and last measurement collected equal to 'Yes' even if there are at least one 'No' in one of the other collected measurements. Stable absent (i.e., all measurements 'No), Stable present (i.e., all measurements 'Yes'), Improved (i.e., last measurement collected as 'No' and baseline 'Yes'), Worsened (i.e., last measurement collected 'Yes' and baseline 'No').

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=27 Participants Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Potential Predictor Factors of Fluid-free Response: External Limiting Membrane (ELM) Integrity Loss in Center 1 mm - Patients Classified as q12w Fluid-free Stable absent; q12w fluid free - Yes	8 Participants
Potential Predictor Factors of Fluid-free Response: External Limiting Membrane (ELM) Integrity Loss in Center 1 mm - Patients Classified as q12w Fluid-free Stable present; q12w fluid free - Yes	13 Participants
Potential Predictor Factors of Fluid-free Response: External Limiting Membrane (ELM) Integrity Loss in Center 1 mm - Patients Classified as q12w Fluid-free Improved; q12w fluid free - Yes	3 Participants
Potential Predictor Factors of Fluid-free Response: External Limiting Membrane (ELM) Integrity Loss in Center 1 mm - Patients Classified as q12w Fluid-free Worsened; q12w fluid free - Yes	3 Participants

PRIMARY outcome

Timeframe: Baseline to Week 16

As assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). Percentages were computed on Safety Population within 'No' and 'Yes' groups according to q12w fluid free. * Stable Fibrovascular only (i.e., all measurements 'Fibrovascular only'). * Stable not only fibrovascular (i.e., all measurements 'Predominantly fibrovascular' or 'Predominantly serous' or 'Drusenoid Pigment Epithelial Detachment (PED)'). * From not only fibrovascular to Fibrovascular only (i.e., last measurement collected 'Fibrovascular only' and baseline 'Predominantly fibrovascular' or 'Predominantly serous' or 'Drusenoid PED'). * From Fibrovascular only to not only fibrovascular (i.e., last measurement collected 'Predominantly fibrovascular' or 'Predominantly serous' or 'Drusenoid PED' and baseline 'Fibrovascular only').

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=93 Participants Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Potential Predictor Factors of Fluid-free Response: Type of Pigment Epithelium Detachment (PED) - Patients Classified as Not q12w Fluid-free Stable Fibrovascular only; q12w fluid free - No	38 Participants
Potential Predictor Factors of Fluid-free Response: Type of Pigment Epithelium Detachment (PED) - Patients Classified as Not q12w Fluid-free Stable not only fibrovascular; q12w fluid free - No	28 Participants
Potential Predictor Factors of Fluid-free Response: Type of Pigment Epithelium Detachment (PED) - Patients Classified as Not q12w Fluid-free From not only fibrovascular to Fibrovascular only; q12w fluid free - No	24 Participants
Potential Predictor Factors of Fluid-free Response: Type of Pigment Epithelium Detachment (PED) - Patients Classified as Not q12w Fluid-free From Fibrovascular only to not only fibrovascular; q12w fluid free - No	3 Participants

PRIMARY outcome

Timeframe: Baseline to Week 16

Population: Full Analysis Set - includes all patients who received at least one dose of the study drug and with a valid measurement without a protocol deviation with impact and who were classified as q12w fluid-free (N=27). (Excludes patients with protocol deviations.)

As assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). Percentages were computed on Safety Population within 'No' and 'Yes' groups according to q12w fluid free. * Stable Fibrovascular only (i.e., all measurements 'Fibrovascular only'). * Stable not only fibrovascular (i.e., all measurements 'Predominantly fibrovascular' or 'Predominantly serous' or 'Drusenoid Pigment Epithelial Detachment (PED)'). * From not only fibrovascular to Fibrovascular only (i.e., last measurement collected 'Fibrovascular only' and baseline 'Predominantly fibrovascular' or 'Predominantly serous' or 'Drusenoid PED'). * From Fibrovascular only to not only fibrovascular (i.e., last measurement collected 'Predominantly fibrovascular' or 'Predominantly serous' or 'Drusenoid PED' and baseline 'Fibrovascular only').

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=27 Participants Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Potential Predictor Factors of Fluid-free Response: Type of Pigment Epithelium Detachment (PED) - Patients Classified as q12w Fluid-free Stable Fibrovascular only; q12w fluid free - Yes	13 Participants
Potential Predictor Factors of Fluid-free Response: Type of Pigment Epithelium Detachment (PED) - Patients Classified as q12w Fluid-free Stable not only fibrovascular; q12w fluid free - Yes	7 Participants
Potential Predictor Factors of Fluid-free Response: Type of Pigment Epithelium Detachment (PED) - Patients Classified as q12w Fluid-free From not only fibrovascular to Fibrovascular only; q12w fluid free - Yes	7 Participants
Potential Predictor Factors of Fluid-free Response: Type of Pigment Epithelium Detachment (PED) - Patients Classified as q12w Fluid-free From Fibrovascular only to not only fibrovascular; q12w fluid free - Yes	0 Participants

PRIMARY outcome

Timeframe: Baseline, Week 16

Population: Full Analysis Set - includes all patients who received at least one dose of the study drug and with a valid measurement without a protocol deviation with impact and who were classified as q12w fluid-free (N=27). (Excludes patients with protocol deviations.)

As assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). Mean (SD) was computed on the Safety Population within 'No' and 'Yes' groups according to q12w fluid free.

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=27 Participants Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Potential Predictor Factors of Fluid-free Response: Percentage Changes in Central Subfield Thickness (CST) From Baseline at Week 16 - Patients Classified as q12w Fluid-free	-36.4 Percentage change Standard Deviation 16.85

PRIMARY outcome

Timeframe: Baseline, Week 16

Population: Full Analysis Set - includes all patients who received at least one dose of the study drug and who were classified as not q12w fluid-free and with a valid measurement without a protocol deviation with impact. (N=92). (Excludes patients with protocol deviations.)

As assessed by Spectral Domain Optical Coherence Tomography (SD-OCT). Mean (SD) was computed on the Safety Population within 'No' and 'Yes' groups according to q12w fluid free.

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=92 Participants Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Potential Predictor Factors of Fluid-free Response: Percentage Changes in Central Subfield Thickness (CST) From Baseline at Week 16 - Patients Classified as Not q12w Fluid-free	-31.7 Percentage change Standard Deviation 18.28

SECONDARY outcome

Timeframe: Baseline, Week 16, Week 48

Population: Full Analysis Set - includes all patients who received at least one dose of the study drug with a valid measurement without a protocol deviation with impact.

Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative OCTA parameters of wet Age-related Macular Degeneration (wAMD) The morphology of the Neovascularization (CNV) complex was evaluated qualitatively by assessing the presence/absence of branching vessels. The presence of tiny vessels branching from bigger vessels is indicative of an active CNV lesion. UNG/P = Ungradable due to pathology UNG/Q = Ungradable due to Quality

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=114 Participants Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Branching Vessels Branching Vessels - Increased from prior - Week 16	11 Participants
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Branching Vessels Branching Vessels - Increased from prior - Week 48 (n=91)	4 Participants
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Branching Vessels Branching Vessels - Decreased from prior - Week 16	2 Participants
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Branching Vessels Branching Vessels - Decreased from prior - Week 48 (n=91)	11 Participants
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Branching Vessels Branching Vessels - Stable - Week 16	26 Participants
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Branching Vessels Branching Vessels - Stable - Week 48 (n=91)	20 Participants
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Branching Vessels Branching Vessels - UNG/P - Week 16	9 Participants
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Branching Vessels Branching Vessels - UNG/P - Week 48 (n=91)	21 Participants
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Branching Vessels Branching Vessels - UNG/Q - Week 16	66 Participants
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Branching Vessels Branching Vessels - UNG/Q - Week 48 (n=91)	35 Participants

SECONDARY outcome

Timeframe: Baseline, Week 16, Week 48

Population: Full Analysis Set - includes all patients with a CNV lesion who received at least one dose of the study drug with a valid measurement without a protocol deviation with impact.

Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative OCTA parameters of wet Age-related Macular Degeneration (wAMD). The total Basal Choroidal Neovascularization (CNV) lesion area (mm\^2) and greatest linear diameter of lesion (mm) are the parameters related to CNV flow size.

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=27 Participants Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Change From Baseline of Total CNV Lesion Area (mm*2) Week 16 (n=27)	0.476 mm^2 Standard Deviation 1.0012
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Change From Baseline of Total CNV Lesion Area (mm*2) Week 48 (n=20)	0.533 mm^2 Standard Deviation 0.9053

SECONDARY outcome

Timeframe: Baseline, Week 16, Week 48

Population: Full Analysis Set - includes all patients who received at least one dose of the study drug with a valid measurement without a protocol deviation with impact.

Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative OCTA parameters of wet Age-related Macular Degeneration (wAMD). The Choroidal Neovascularization (CNV) vascular density (%) is calculated as a ratio of the area occupied by vessels and the total area of the lesion and multiplied by 100.

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=9 Participants Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Change From Baseline of Choroidal Neovascularization (CNV) Vascular Density (%) Week 16	1.326 % CNV Vascular Density Standard Deviation 35.6003
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Change From Baseline of Choroidal Neovascularization (CNV) Vascular Density (%) Week 48 (n=8)	29.900 % CNV Vascular Density Standard Deviation 52.3079

SECONDARY outcome

Timeframe: Baseline, Week 16, Week 48

Population: Full Analysis Set - includes all patients who received at least one dose of the study drug with a valid measurement without a protocol deviation with impact.

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=27 Participants Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Change From Baseline of Lesion Greatest Linear Diameter (mm) Week 16	-0.211 mm Standard Deviation 0.5416
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Change From Baseline of Lesion Greatest Linear Diameter (mm) Week 48 (n=20)	-0.147 mm Standard Deviation 0.5837

SECONDARY outcome

Timeframe: Baseline, Week 16, Week 48

Population: Full Analysis Set - includes all patients who received at least one dose of the study drug with a valid measurement without a protocol deviation with impact.

Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative OCTA parameters of wet Age-related Macular Degeneration (wAMD). The morphology of the Choroidal Neovascularization (CNV) complex was evaluated qualitatively by assessing the peripheral anastomotic arcades. The presence of peripheral anastomotic arcades at the vessel termini is indicative of an active CNV lesion.

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=25 Participants Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Peripheral Anastomotic Arcades No at Baseline and No at Week 16	14 Participants
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Peripheral Anastomotic Arcades Yes at Baseline and No at Week 16	1 Participants
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Peripheral Anastomotic Arcades No at Baseline and Yes at Week 16	4 Participants
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Peripheral Anastomotic Arcades Yes at Baseline and Yes at Week 16	6 Participants
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Peripheral Anastomotic Arcades No at Baseline and No at Week 48 (n=21)	7 Participants
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Peripheral Anastomotic Arcades Yes at Baseline and No at Week 48 (n=21)	2 Participants
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Peripheral Anastomotic Arcades No at Baseline and Yes at Week 48 (n=21)	8 Participants
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Peripheral Anastomotic Arcades Yes at Baseline and Yes at Week 48 (n=21)	4 Participants

SECONDARY outcome

Timeframe: Baseline, Week 16, Week 48

Population: Full Analysis Set - includes all patients who received at least one dose of the study drug with a valid measurement without a protocol deviation with impact.

Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative OCTA parameters of wet Age-related Macular Degeneration (wAMD). The morphology of the Choroidal Neovascularization (CNV) complex was evaluated qualitatively by assessing the vascular loops. The presence of vascular loops is indicative of an active CNV lesion.

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=26 Participants Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Vascular Loops No at Baseline and No at Week 16	12 Participants
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Vascular Loops Yes at Baseline and No at Week 16	1 Participants
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Vascular Loops No at Baseline and Yes at Week 16	3 Participants
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Vascular Loops Yes at Baseline and Yes at Week 16	10 Participants
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Vascular Loops No at Baseline and No at Week 48 (n=22)	4 Participants
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Vascular Loops Yes at Baseline and No at Week 48 (n=22)	3 Participants
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Vascular Loops No at Baseline and Yes at Week 48 (n=22)	7 Participants
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Vascular Loops Yes at Baseline and Yes at Week 48 (n=22)	8 Participants

SECONDARY outcome

Timeframe: Baseline, Week 16, Week 48

Population: Full Analysis Set - includes all patients who received at least one dose of the study drug with a valid measurement without a protocol deviation with impact.

Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative OCTA parameters of wet Age-related Macular Degeneration (wAMD). The morphology of the Choroidal Neovascularization (CNV) complex was evaluated qualitatively by assessing the dark halo. The presence of dark halo is considered a region of choriocapillaris alteration corresponding to local flow impairment and is indicative of an active CNV lesion.

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=17 Participants Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Dark Halo No at Baseline and No at Week 16 (n=15)	9 Participants
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Dark Halo Yes at Baseline and No at Week 16 (n=15)	2 Participants
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Dark Halo No at Baseline and Yes at Week 16 (n=15)	0 Participants
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Dark Halo Yes at Baseline and Yes at Week 16 (n=15)	4 Participants
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Dark Halo No at Baseline and No at Week 48 (n=17)	6 Participants
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Dark Halo Yes at Baseline and No at Week 48 (n=17)	5 Participants
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Dark Halo No at Baseline and Yes at Week 48 (n=17)	2 Participants
Change in Optical Coherence Tomography (OCTA) Features Baseline up to Week 48 - Dark Halo Yes at Baseline and Yes at Week 48 (n=17)	4 Participants

SECONDARY outcome

Timeframe: Baseline, Week 16, Week 48

Population: Full Analysis Set - includes all patients who received at least one dose of the study drug with a valid measurement without a protocol deviation with impact.

Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative SCD-OCT parameters of wet Age-related Macular Degeneration (wAMD)

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=120 Participants Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Spectral Domain Optical Coherence Tomography (SD-OCT) Features Baseline up to Week 48 - Pigment Epithelial Detachment (PED) Yes - Baseline	120 Participants
Spectral Domain Optical Coherence Tomography (SD-OCT) Features Baseline up to Week 48 - Pigment Epithelial Detachment (PED) Yes - Week 16 (n=114)	114 Participants
Spectral Domain Optical Coherence Tomography (SD-OCT) Features Baseline up to Week 48 - Pigment Epithelial Detachment (PED) Yes - Week 48 (n=93)	92 Participants
Spectral Domain Optical Coherence Tomography (SD-OCT) Features Baseline up to Week 48 - Pigment Epithelial Detachment (PED) Missing - Week 48 (n=93)	1 Participants

SECONDARY outcome

Timeframe: Baseline, Week 16, Week 48

Population: Full Analysis Set - includes all patients who received at least one dose of the study drug with a valid measurement without a protocol deviation with impact.

Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative SCD-OCT parameters of wet Age-related Macular Degeneration (wAMD). The central retina thickness (CRT) evaluated in this study represents the average retinal thickness of the circular area within 1 mm diameter around the foveal center and was called Center Subfield Thickness (CST), also known as foveal thickness.

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=120 Participants Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Spectral Domain Optical Coherence Tomography (SD-OCT) Features Baseline up to Week 48 - Central Subfield Thickness (CST) (μm) Baseline	482.6 micrometers Standard Deviation 177.40
Spectral Domain Optical Coherence Tomography (SD-OCT) Features Baseline up to Week 48 - Central Subfield Thickness (CST) (μm) Week 16 (n=114)	309.2 micrometers Standard Deviation 107.69
Spectral Domain Optical Coherence Tomography (SD-OCT) Features Baseline up to Week 48 - Central Subfield Thickness (CST) (μm) Week 48 (n=93)	307.9 micrometers Standard Deviation 118.05

SECONDARY outcome

Timeframe: Baseline, Week 16, Week 48

Population: Full Analysis Set - includes all patients who received at least one dose of the study drug with a valid measurement without a protocol deviation with impact.

Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative OCTA parameters of wet Age-related Macular Degeneration (wAMD)

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=76 Participants Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 Week 16	-188.4 micrometers Standard Deviation 142.79
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 Week 48 (n=60)	-197.6 micrometers Standard Deviation 152.63

SECONDARY outcome

Timeframe: Baseline, Week 16, Week 48

Population: Full Analysis Set - includes all patients who received at least one dose of the study drug with a valid measurement without a protocol deviation with impact.

Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative SCD-OCT parameters of wet Age-related Macular Degeneration (wAMD). IRF is the fluid that accumulates within the neurosensory retina due to the disruption of the external limiting membrane (ELM)-photoreceptor complex in the outer retina by the active Choroidal Neovascularization (CNV) membrane.

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=114 Participants Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Intraretinal Fluid (IRF) Cystoid Edema No at Baseline and No at Week 16	46 Participants
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Intraretinal Fluid (IRF) Cystoid Edema Yes at Baseline and No at Week 16	38 Participants
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Intraretinal Fluid (IRF) Cystoid Edema No at Baseline and Yes at Week 16	4 Participants
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Intraretinal Fluid (IRF) Cystoid Edema Yes at Baseline and Yes at Week 16	26 Participants
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Intraretinal Fluid (IRF) Cystoid Edema No at Baseline and No at Week 48 (n=92)	40 Participants
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Intraretinal Fluid (IRF) Cystoid Edema Yes at Baseline and No at Week 48 (n=92)	30 Participants
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Intraretinal Fluid (IRF) Cystoid Edema No at Baseline and Yes at Week 48 (n=92)	1 Participants
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Intraretinal Fluid (IRF) Cystoid Edema Yes at Baseline and Yes at Week 48 (n=92)	21 Participants

SECONDARY outcome

Timeframe: Baseline, Week 16, Week 48

Population: Full Analysis Set - includes all patients who received at least one dose of the study drug with a valid measurement without a protocol deviation with impact.

Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative SCD-OCT parameters of wet Age-related Macular Degeneration (wAMD). SRF is the fluid that commonly accumulates between the neurosensory retina and the retinal pigment epithelium (RPE) due to the profuse leakage from blood vessels of the Choroidal Neovascularization (CNV) complex.

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=114 Participants Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Subretinal Fluid (SRF) No at Baseline and No at Week 16	7 Participants
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Subretinal Fluid (SRF) Yes at Baseline and No at Week 16	75 Participants
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Subretinal Fluid (SRF) No at Baseline and Yes at Week 16	1 Participants
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Subretinal Fluid (SRF) Yes at Baseline and Yes at Week 16	31 Participants
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Subretinal Fluid (SRF) No at Baseline and No at Week 48 (n=92)	6 Participants
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Subretinal Fluid (SRF) Yes at Baseline and No at Week 48 (n=92)	57 Participants
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Subretinal Fluid (SRF) No at Baseline and Yes at Week 48 (n=92)	0 Participants
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Subretinal Fluid (SRF) Yes at Baseline and Yes at Week 48 (n=92)	29 Participants

SECONDARY outcome

Timeframe: Baseline, Week 16, Week 48

Population: Full Analysis Set - includes all patients who received at least one dose of the study drug with a valid measurement without a protocol deviation with impact.

Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative SCD-OCT parameters of wet Age-related Macular Degeneration (wAMD). Sub-RPE fluid, i.e., the fluid that accumulates under the RPE, thus often leading to Pigment Epithelial Detachments (PEDs).

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=114 Participants Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Sub Retinal Pigment Epithelium (Sub RPE) Fluid No at Baseline and No at Week 16	49 Participants
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Sub Retinal Pigment Epithelium (Sub RPE) Fluid Yes at Baseline and No at Week 16	26 Participants
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Sub Retinal Pigment Epithelium (Sub RPE) Fluid No at Baseline and Yes at Week 16	1 Participants
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Sub Retinal Pigment Epithelium (Sub RPE) Fluid Yes at Baseline and Yes at Week 16	38 Participants
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Sub Retinal Pigment Epithelium (Sub RPE) Fluid No at Baseline and No at Week 48 (n=92)	36 Participants
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Sub Retinal Pigment Epithelium (Sub RPE) Fluid Yes at Baseline and No at Week 48 (n=92)	26 Participants
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Sub Retinal Pigment Epithelium (Sub RPE) Fluid No at Baseline and Yes at Week 48 (n=92)	2 Participants
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Sub Retinal Pigment Epithelium (Sub RPE) Fluid Yes at Baseline and Yes at Week 48 (n=92)	28 Participants

SECONDARY outcome

Timeframe: Baseline, Week 16, Week 48

Population: Full Analysis Set - includes all patients who received at least one dose of the study drug with a valid measurement without a protocol deviation with impact.

Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative SCD-OCT parameters of wet Age-related Macular Degeneration (wAMD). SHRM, i.e., a poorly defined, medium-to-hyperreflective mass between the neurosensory layers and the sub retinal pigment epithelium (RPE) on SD-OCT, which is indicative of the neurovascular membrane, particularly in type II Choroidal Neovascularization (CNV) lesions, and of disciform scar formation

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=114 Participants Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Subretinal Hyperreflective Material (SHRM) No at Baseline and No at Week 16	50 Participants
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Subretinal Hyperreflective Material (SHRM) Yes at Baseline and No at Week 16	11 Participants
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Subretinal Hyperreflective Material (SHRM) No at Baseline and Yes at Week 16	16 Participants
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Subretinal Hyperreflective Material (SHRM) Yes at Baseline and Yes at Week 16	37 Participants
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Subretinal Hyperreflective Material (SHRM) No at Baseline and No at Week 48 (n=92)	45 Participants
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Subretinal Hyperreflective Material (SHRM) Yes at Baseline and No at Week 48 (n=92)	14 Participants
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Subretinal Hyperreflective Material (SHRM) No at Baseline and Yes at Week 48 (n=92)	8 Participants
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Subretinal Hyperreflective Material (SHRM) Yes at Baseline and Yes at Week 48 (n=92)	25 Participants

SECONDARY outcome

Timeframe: Baseline, Week 16, Week 48

Population: Full Analysis Set - includes all patients who received at least one dose of the study drug with a valid measurement without a protocol deviation with impact.

Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative SCD-OCT parameters of wet Age-related Macular Degeneration (wAMD). ORT, i.e., branching tubular structures located in the outer nuclear layer of the retina, which seems to be indicative of a rearrangement of degenerating photoreceptors in a variety of retinal diseases, including wAMD. On SD-OCT, ORT appears as well-defined round or ovoid hyporeflective spaces with hyperreflective borders.

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=114 Participants Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Outer Retinal Tubulation (ORT) No at Baseline and No at Week 16	103 Participants
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Outer Retinal Tubulation (ORT) Yes at Baseline and No at Week 16	3 Participants
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Outer Retinal Tubulation (ORT) No at Baseline and Yes at Week 16	5 Participants
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Outer Retinal Tubulation (ORT) Yes at Baseline and Yes at Week 16	3 Participants
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Outer Retinal Tubulation (ORT) No at Baseline and No at Week 48 (n=92)	77 Participants
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Outer Retinal Tubulation (ORT) Yes at Baseline and No at Week 48 (n=92)	3 Participants
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Outer Retinal Tubulation (ORT) No at Baseline and Yes at Week 48 (n=92)	10 Participants
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - Outer Retinal Tubulation (ORT) Yes at Baseline and Yes at Week 48 (n=92)	2 Participants

SECONDARY outcome

Timeframe: Baseline, Week 16, Week 48

Population: Full Analysis Set - includes all patients who received at least one dose of the study drug with a valid measurement without a protocol deviation with impact.

Evaluate the effect of brolucizumab on the evolution of qualitative and quantitative SCD-OCT parameters of wet Age-related Macular Degeneration (wAMD). Status of the ELM as an indicator of retinal integrity was evaluated focusing on ELM integrity loss in center 1 mm (i.e., considering the central 1 x 1-mm subfield).

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=113 Participants Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - External Limiting Membrane (ELM) Integrity Loss No at Baseline and No at Week 16	30 Participants
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - External Limiting Membrane (ELM) Integrity Loss Yes at Baseline and No at Week 16	14 Participants
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - External Limiting Membrane (ELM) Integrity Loss No at Baseline and Yes at Week 16	15 Participants
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - External Limiting Membrane (ELM) Integrity Loss Yes at Baseline and Yes at Week 16	54 Participants
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - External Limiting Membrane (ELM) Integrity Loss No at Baseline and No at Week 48 (n=91)	24 Participants
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - External Limiting Membrane (ELM) Integrity Loss Yes at Baseline and No at Week 48 (n=91)	9 Participants
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - External Limiting Membrane (ELM) Integrity Loss No at Baseline and Yes at Week 48 (n=91)	15 Participants
Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Features From Baseline up to Week 48 - External Limiting Membrane (ELM) Integrity Loss Yes at Baseline and Yes at Week 48 (n=91)	43 Participants

SECONDARY outcome

Timeframe: Baseline, Week 16, Week 48

Population: Full Analysis Set - includes all patients who received at least one dose of the study drug with a valid measurement without a protocol deviation with impact.

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 of \>= 34 ETDRS letters (Snellen equivalent 20/200) at Screening / 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

Outcome measures
Measure	Brolucizumab 6 mg n=120 Participants Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Change in Best-corrected Visual Acuity (BCVA) From Baseline up to Week 48 Week 16	4.0 Letters read Interval 0.0 to 10.0
Change in Best-corrected Visual Acuity (BCVA) From Baseline up to Week 48 Week 48	5.5 Letters read Interval -0.5 to 12.0

SECONDARY outcome

Timeframe: Week 16, Week 48

Population: Full Analysis Set - includes all patients with fluid present at Baseline who received at least one dose of the study drug with a valid measurement without a protocol deviation with impact.

Evaluate the effect of brolucizumab on sustained dryness from Baseline to Week 48. Among patients with fluid present at Baseline, patients with fluid resolution were identified in case of absence of IRF and SRF and patients without fluid resolution were categorized in 'only IRF present', 'only SRF present', 'both IRF and SRF present' at each post-baseline timepoint. IRF = Intraretinal Fluid SRF = Subretinal Fluid

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=113 Participants Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Number of Patients With Fluid Resolution of the Study Eye Patients with fluid resolution - Week 16	64 Participants
Number of Patients With Fluid Resolution of the Study Eye Patients without fluid resolution - Week 16	49 Participants
Number of Patients With Fluid Resolution of the Study Eye Patients without fluid resolution - Only IRF present - Week 16 (n=49)	18 Participants
Number of Patients With Fluid Resolution of the Study Eye Patients without fluid resolution - Only SRF present - Week 16 (n=49)	19 Participants
Number of Patients With Fluid Resolution of the Study Eye Patients without fluid resolution - Both IRF and SRF present - Week 16 (n=49)	12 Participants
Number of Patients With Fluid Resolution of the Study Eye Patients with fluid resolution - Week 48 (n=92)	49 Participants
Number of Patients With Fluid Resolution of the Study Eye Unknown- Week 48 (n=92)	1 Participants
Number of Patients With Fluid Resolution of the Study Eye Patients without fluid resolution - Week 48 (n=92)	42 Participants
Number of Patients With Fluid Resolution of the Study Eye Patients without fluid resolution - Only IRF present - Week 48 (n=42)	13 Participants
Number of Patients With Fluid Resolution of the Study Eye Patients without fluid resolution - Only SRF present - Week 48 (n=42)	20 Participants
Number of Patients With Fluid Resolution of the Study Eye Patients without fluid resolution - Both IRF and SRF present - Week 48 (n=42)	9 Participants

SECONDARY outcome

Timeframe: Up to Week 48

Population: Full Analysis Set - includes all patients with fluid present at baseline and who received at least one dose of the study drug with a valid measurement without a protocol deviation with impact.

Evaluate the effect of brolucizumab on sustained dryness from Baseline to Week 48. Patients who achieved sustained dryness were identified considering those with fluid resolution for at least 2/3 consecutive visits. Median time to the achievement of sustained dryness was calculated by the Kaplan-Meier method. Sustained dryness of the study eye, is defined by the absence of IRF and SRF for at least 2 consecutive visits and for at least 3 consecutive visits. IRF = Intraretinal Fluid SRF = Subretinal Fluid

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=119 Participants Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Sustained Dryness of the Study Eye - Kaplan-Meier Estimates - Median Time to the Achievement of Sustained Dryness	16.43 weeks Interval 12.86 to 31.0

SECONDARY outcome

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

Population: Full Analysis Set - includes all patients with fluid present at baseline who received at least one dose of the study drug with a valid measurement without a protocol deviation with impact.

Evaluate the effect of brolucizumab on sustained dryness from Baseline to Week 48. Sustained dryness of the study eye, is defined by the absence of IRF and SRF for at least 2 consecutive visits and for at least 3 consecutive visits. IRF = Intraretinal Fluid SRF = Subretinal Fluid

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=119 Participants Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Cumulative Incidence of Patients With Sustained Dryness of the Study Eye Patients with sustained dryness - Week 8	36 Participants
Cumulative Incidence of Patients With Sustained Dryness of the Study Eye Patients with sustained dryness - Week 12	54 Participants
Cumulative Incidence of Patients With Sustained Dryness of the Study Eye Patients with sustained dryness - Week 16	64 Participants
Cumulative Incidence of Patients With Sustained Dryness of the Study Eye Patients with sustained dryness - Week 20	68 Participants
Cumulative Incidence of Patients With Sustained Dryness of the Study Eye Patients with sustained dryness - Week 24	68 Participants
Cumulative Incidence of Patients With Sustained Dryness of the Study Eye Patients with sustained dryness - Week 28	68 Participants
Cumulative Incidence of Patients With Sustained Dryness of the Study Eye Patients with sustained dryness - Week 32	73 Participants
Cumulative Incidence of Patients With Sustained Dryness of the Study Eye Patients with sustained dryness - Week 36	76 Participants
Cumulative Incidence of Patients With Sustained Dryness of the Study Eye Patients with sustained dryness - Week 40	77 Participants
Cumulative Incidence of Patients With Sustained Dryness of the Study Eye Patients with sustained dryness - Week 44	77 Participants
Cumulative Incidence of Patients With Sustained Dryness of the Study Eye Patients with sustained dryness - Week 48	78 Participants

SECONDARY outcome

Timeframe: Up to Week 16

Population: Full Analysis Set - iincludes Patients who performed Week 16 and still on treatment of brolucizumab dosing regimen (q8w) with a valid measurement without a protocol deviation with impact.

Evaluate the reasons underlying the Investigators' choice of brolucizumab treatment regimen (q8w) BVCA=Best-Corrected Visual Acuity, CFP=Color Fundus Photography; CNV=Choroidal Neovascularization; FA=Fluorescein Angiography; ICGA=IndoCyanine Green Angiography; OCTA=Optical Coherence Tomography Angiography; SD-OCT=Spectral Domain Optical Coherence Tomography

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=42 Participants Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Determinants in the Investigator's Choice of Brolucizumab Dosing Regimen (q8w) at Week 16 Intraretinal fluid (IRF) at SD-OCT	17 Participants
Determinants in the Investigator's Choice of Brolucizumab Dosing Regimen (q8w) at Week 16 Subretinal fluid (SRF) at SD-OCT	21 Participants
Determinants in the Investigator's Choice of Brolucizumab Dosing Regimen (q8w) at Week 16 Central Subfield Thickness (CST) at SD-OCT	15 Participants
Determinants in the Investigator's Choice of Brolucizumab Dosing Regimen (q8w) at Week 16 Best-corrected visual acuity (BCVA)	13 Participants
Determinants in the Investigator's Choice of Brolucizumab Dosing Regimen (q8w) at Week 16 Subretinal pigment epithelium (sub-RPE) fluid at SD-OCT	4 Participants
Determinants in the Investigator's Choice of Brolucizumab Dosing Regimen (q8w) at Week 16 Central Retinal Thickness (CRT)	4 Participants
Determinants in the Investigator's Choice of Brolucizumab Dosing Regimen (q8w) at Week 16 Subretinal hyperreflective material (SHRM) at Domain Optical Coherence Tomography. (SD-OCT)	6 Participants
Determinants in the Investigator's Choice of Brolucizumab Dosing Regimen (q8w) at Week 16 Retina Pigment Epithelial Detachment volume at SD-OCT	3 Participants
Determinants in the Investigator's Choice of Brolucizumab Dosing Regimen (q8w) at Week 16 CNV size at OCTA	2 Participants
Determinants in the Investigator's Choice of Brolucizumab Dosing Regimen (q8w) at Week 16 Hemorrhage at CFP	2 Participants
Determinants in the Investigator's Choice of Brolucizumab Dosing Regimen (q8w) at Week 16 Vessel morphology at OCTA	2 Participants
Determinants in the Investigator's Choice of Brolucizumab Dosing Regimen (q8w) at Week 16 Vessel density at OCTA	3 Participants
Determinants in the Investigator's Choice of Brolucizumab Dosing Regimen (q8w) at Week 16 Other - investigator's discretion	2 Participants
Determinants in the Investigator's Choice of Brolucizumab Dosing Regimen (q8w) at Week 16 Leakage at FA/ICGA	0 Participants

SECONDARY outcome

Timeframe: Up to Week 16

Population: Full Analysis Set - includes Patients who performed Week 16 and still on treatment of brolucizumab dosing regimen (q12w) with a valid measurement without a protocol deviation with impact.

Evaluate the reasons underlying the Investigators' choice of brolucizumab treatment regimen (q12w) BVCA=Best-Corrected Visual Acuity, CFP=Color Fundus Photography; CNV=Choroidal Neovascularization; FA=Fluorescein Angiography; ICGA=IndoCyanine Green Angiography; OCTA=Optical Coherence Tomography Angiography; SD-OCT=Spectral Domain Optical Coherence Tomography

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=68 Participants Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Determinants in the Investigator's Choice of Brolucizumab Dosing Regimen (q12w) at Week 16 Intraretinal fluid (IRF) at SD-OCT	46 Participants
Determinants in the Investigator's Choice of Brolucizumab Dosing Regimen (q12w) at Week 16 Subretinal fluid (SRF) at SD-OCT	41 Participants
Determinants in the Investigator's Choice of Brolucizumab Dosing Regimen (q12w) at Week 16 Central Subfield Thickness (CST) at SD-OCT	35 Participants
Determinants in the Investigator's Choice of Brolucizumab Dosing Regimen (q12w) at Week 16 BCVA	29 Participants
Determinants in the Investigator's Choice of Brolucizumab Dosing Regimen (q12w) at Week 16 Subretinal pigment epithelium (sub-RPE) fluid at SD-OCT	26 Participants
Determinants in the Investigator's Choice of Brolucizumab Dosing Regimen (q12w) at Week 16 Central Retinal Thickness (CRT)	26 Participants
Determinants in the Investigator's Choice of Brolucizumab Dosing Regimen (q12w) at Week 16 Subretinal hyperreflective material (SHRM) at SD-OCT	22 Participants
Determinants in the Investigator's Choice of Brolucizumab Dosing Regimen (q12w) at Week 16 Retina Pigment Epithelial Detachment volume at SD-OCT	19 Participants
Determinants in the Investigator's Choice of Brolucizumab Dosing Regimen (q12w) at Week 16 CNV size at OCTA	18 Participants
Determinants in the Investigator's Choice of Brolucizumab Dosing Regimen (q12w) at Week 16 Hemorrhage at CFP	17 Participants
Determinants in the Investigator's Choice of Brolucizumab Dosing Regimen (q12w) at Week 16 Vessel morphology at OCTA	13 Participants
Determinants in the Investigator's Choice of Brolucizumab Dosing Regimen (q12w) at Week 16 Vessel density at OCTA	11 Participants
Determinants in the Investigator's Choice of Brolucizumab Dosing Regimen (q12w) at Week 16 Other - investigator's discretion	11 Participants
Determinants in the Investigator's Choice of Brolucizumab Dosing Regimen (q12w) at Week 16 Leakage at FA/ICGA	0 Participants

SECONDARY outcome

Timeframe: Up to Week 48

Population: Full Analysis Set - includes all patients who received at least one dose of the study drug with a valid measurement without a protocol deviation with impact.

Evaluate anxiety/depression in patients with wAMD treated with brolucizumab. The Hospital Anxiety and Depression Scale (HADS) is a fourteen-item scale that generates ordinal data. Seven items relate to anxiety and seven relate to depression. This patient-reported outcome measure was specifically developed to avoid reliance on anxiety/depression aspects which are also common somatic symptoms of illness, such as fatigue and insomnia or hypersomnia. Calculations of scores: each item is rated on a 4-point scale. The HADS consists of two sub-scores: the HAD-A for anxiety and HAD-D for depression. Each sub-score ranges from 0 to 21 points: scores ≥11 indicate the presence of an anxious or depressive disorder, scores between 8-10 points are borderline abnormal, and scores ≤7 indicate that an anxious or depressive disorder is not present.

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=96 Participants Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Change in Hospital Anxiety and Depression Scale (HADS) Scores HAD-A - Absolute change from baseline at Week 48	-0.78 Scores on a scale Standard Deviation 3.258
Change in Hospital Anxiety and Depression Scale (HADS) Scores HAD-D - Absolute change from baseline at Week 48	-0.10 Scores on a scale Standard Deviation 3.049

SECONDARY outcome

Timeframe: Baseline, Week 48

Population: Full Analysis Set - includes all patients who received at least one dose of the study drug with a valid measurement without a protocol deviation with impact.

Evaluate quality of life in patients with wAMD treated with brolucizumab. The EQ-5D-5L is a standardized widely used instrument for measuring generic health status. It comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels. i.e. no problems, slight problems, moderate problems, severe problems and extreme problems, corresponding to digit numbers ranging from 1 to 5. The EQ-5D-5L total score is determined through a Visual Analogue Scale (VAS) and ranges from 0 to 100 with higher scores indicative of a better health status.

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=96 Participants Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Change in European Quality of Life-5D-5L (EQ-5D-5L) Scores	0.00 Scores on a scale Standard Deviation 0.147

SECONDARY outcome

Timeframe: AEs are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.

Population: Safety Set - includes all patients who received at least one dose of the study drug

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

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=122 Participants Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Treatment Emergent Adverse Events Patients with TEAEs	59 Participants
Treatment Emergent Adverse Events Patients with Serious TEAEs	14 Participants
Treatment Emergent Adverse Events Patients with Ocular TEAEs	33 Participants
Treatment Emergent Adverse Events Patients with non-ocular TEAEs	40 Participants
Treatment Emergent Adverse Events Patients with suspected drug-related TEAEs	13 Participants
Treatment Emergent Adverse Events Patients with TEAEs related to Ocular injection procedure	4 Participants
Treatment Emergent Adverse Events Patients with TEAEs leading to temporary interruption of treatment	2 Participants
Treatment Emergent Adverse Events Patients with TEAEs leading to withdrawn of treatment	15 Participants
Treatment Emergent Adverse Events Patients with TEAEs leading to study discontinuation	7 Participants
Treatment Emergent Adverse Events Patients with TEAEs with fatal outcome	0 Participants

SECONDARY outcome

Timeframe: AEs are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.

Population: Safety Set - includes all patients who received at least one dose of the study drug

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=122 Participants Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Ocular Treatment Emergent Adverse Events - Study Eye Patients with Ocular TEAEs	25 Participants
Ocular Treatment Emergent Adverse Events - Study Eye Patients with Serious Ocular TEAEs	1 Participants
Ocular Treatment Emergent Adverse Events - Study Eye Patients with suspected drug-related Ocular TEAEs	11 Participants
Ocular Treatment Emergent Adverse Events - Study Eye Patients with Ocular TEAEs related to Ocular injection procedure	3 Participants
Ocular Treatment Emergent Adverse Events - Study Eye Patients with Ocular TEAEs leading to temporary interruption of treatment	1 Participants
Ocular Treatment Emergent Adverse Events - Study Eye Patients with Ocular TEAEs leading to withdrawn of treatment	10 Participants
Ocular Treatment Emergent Adverse Events - Study Eye Patients with Ocular TEAEs leading to study discontinuation	5 Participants
Ocular Treatment Emergent Adverse Events - Study Eye Patients with Ocular TEAEs with fatal outcome	0 Participants

SECONDARY outcome

Timeframe: AEs are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.

Population: Safety Set - includes all patients who received at least one dose of the study drug

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=122 Participants Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Ocular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT) -Visual impairment	1 Participants
Ocular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT) Eye disorders	30 Participants
Ocular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT) -Cataract	3 Participants
Ocular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT) -Conjunctival haemorrhage	1 Participants
Ocular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT) -Eye haemorrhage	1 Participants
Ocular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT) -Eye inflammation	2 Participants
Ocular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT) -Iridocyclitis	1 Participants
Ocular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT) -Macular degeneration	1 Participants
Ocular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT) -Macular detachment	1 Participants
Ocular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT) -Macular fibrosis	2 Participants
Ocular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT) -Macular hole	3 Participants
Ocular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT) -Maculopathy	1 Participants
Ocular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT) -Neovascular age-related macular degeneration	3 Participants
Ocular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT) -Ocular hypertension	2 Participants
Ocular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT) -Retinal haemorrhage	1 Participants
Ocular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT) -Retinal occlusive vasculitis	1 Participants
Ocular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT) -Retinal pigment epithelial tear	3 Participants
Ocular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT) -Retinal tear	2 Participants
Ocular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT) -Retinal vascular disorder	1 Participants
Ocular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT) -Retinal vasculitis	1 Participants
Ocular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT) -Uveitis	1 Participants
Ocular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT) -Vision blurred	1 Participants
Ocular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT) -Vitreous floaters	1 Participants
Ocular Treatment Emergent Adverse Events - by System Organ Class (SOC) and Preferred Term (PT) -Vitritis	5 Participants

Adverse Events

Brolucizumab 6 mg

Serious events: 14 serious events

Other events: 52 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Brolucizumab 6 mg n=122 participants at risk Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Cardiac disorders Acute myocardial infarction	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Eye disorders Retinal occlusive vasculitis- Study eye	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Eye disorders Uveitis- Study eye	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Gastrointestinal disorders Intestinal obstruction	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
General disorders Asthenia	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
General disorders Condition aggravated	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Injury, poisoning and procedural complications Fall	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Injury, poisoning and procedural complications Joint dislocation	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute undifferentiated leukaemia	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Nervous system disorders Cerebellar ischaemia	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Nervous system disorders Cerebrovascular accident	1.6% 2/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Nervous system disorders Transient ischaemic attack	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.

Other adverse events

Other adverse events
Measure	Brolucizumab 6 mg n=122 participants at risk Participants received 3 monthly ocular injections followed by a q12w or q8w maintenance phase based on patient's disease activity (DA).
Cardiac disorders Atrial fibrillation	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Cardiac disorders Cardiac failure	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Cardiac disorders Conduction disorder	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Cardiac disorders Defect conduction intraventricular	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Cardiac disorders Diastolic dysfunction	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Eye disorders Cataract- Both	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Eye disorders Cataract- Fellow eye	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Eye disorders Cataract- Study eye	1.6% 2/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Eye disorders Conjunctival haemorrhage- Study eye	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Eye disorders Eye haemorrhage- Fellow eye	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Eye disorders Eye inflammation- Study eye	1.6% 2/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Eye disorders Iridocyclitis- Study eye	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Eye disorders Macular degeneration- Fellow eye	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Eye disorders Macular detachment- Fellow eye	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Eye disorders Macular fibrosis- Study eye	1.6% 2/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Eye disorders Macular hole- Study eye	2.5% 3/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Eye disorders Maculopathy- Study eye	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Eye disorders Neovascular age-related macular degeneration- Fellow eye	2.5% 3/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Eye disorders Ocular hypertension- Both	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Eye disorders Ocular hypertension- Study eye	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Eye disorders Retinal haemorrhage- Study eye	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Eye disorders Retinal pigment epithelial tear- Study eye	2.5% 3/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Eye disorders Retinal tear- Study eye	1.6% 2/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Eye disorders Retinal vascular disorder- Study eye	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Eye disorders Retinal vasculitis- Study eye	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Eye disorders Vision blurred- Study eye	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Eye disorders Visual impairment- Study eye	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Eye disorders Vitreous floaters- Study eye	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Eye disorders Vitritis- Study eye	4.1% 5/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Gastrointestinal disorders Aphthous ulcer	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Gastrointestinal disorders Colitis	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Gastrointestinal disorders Toothache	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Gastrointestinal disorders Vomiting	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Infections and infestations Bronchitis	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Infections and infestations COVID-19	10.7% 13/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Infections and infestations Conjunctivitis bacterial- Both	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Infections and infestations Conjunctivitis- Study eye	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Infections and infestations Cystitis	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Infections and infestations Gastroenteritis	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Infections and infestations Influenza	3.3% 4/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Infections and infestations Nasopharyngitis	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Infections and infestations Post procedural infection	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Injury, poisoning and procedural complications Head injury	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Injury, poisoning and procedural complications Rib fracture	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Investigations Blood pressure abnormal	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Metabolism and nutrition disorders Iron deficiency	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Musculoskeletal and connective tissue disorders Arthralgia	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Musculoskeletal and connective tissue disorders Back pain	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Musculoskeletal and connective tissue disorders Myalgia	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Nervous system disorders Arachnoid cyst	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Nervous system disorders Ataxia	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Nervous system disorders Dizziness	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Nervous system disorders Gliosis	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Nervous system disorders Nystagmus- Fellow eye	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Psychiatric disorders Anxiety	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Renal and urinary disorders Renal colic	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Respiratory, thoracic and mediastinal disorders Cough	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Respiratory, thoracic and mediastinal disorders Epistaxis- Fellow eye	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Vascular disorders Hypertension	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.
Vascular disorders Vasculitis- Study eye	0.82% 1/122 • Adverse Events are reported from first dose of study treatment until 4 weeks after last treatment, for a maximum time frame of approx. 48 weeks.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: + 1 862 778 8300

Email: [email protected]

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