Trial Outcomes & Findings for Efficacy and Safety of Two Different Brolucizumab 6 mg Dosing Regimens in Neovascular Age-related Macular Degeneration (NCT NCT04679935)

Last Updated: 2025-09-26

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

52 participants

Primary outcome timeframe

Baseline, Week 40 to Week 52

Results posted on

2025-09-26

Participant Flow

If both eyes were eligible as per the inclusion and exclusion criteria, the eye with the worse visual acuity should have been selected for study eye, unless the investigator deemed it more appropriate to select the eye with better visual acuity, based on medical reasons or local ethical requirements.

Participant milestones

Participant milestones
Measure	Brolucizumab 6 mg Loading 3 x 4-weekly initial injections followed by an injection every 12 weeks	Brolucizumab 6 mg Non-loading One initial injection followed by treatment every 12 weeks
Overall Study STARTED	25	27
Overall Study COMPLETED	25	26
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Brolucizumab 6 mg Loading 3 x 4-weekly initial injections followed by an injection every 12 weeks	Brolucizumab 6 mg Non-loading One initial injection followed by treatment every 12 weeks
Overall Study Death	0	1

Baseline Characteristics

Efficacy and Safety of Two Different Brolucizumab 6 mg Dosing Regimens in Neovascular Age-related Macular Degeneration

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Brolucizumab 6 mg Loading n=25 Participants 3 x 4-weekly initial injections followed by an injection every 12 weeks	Brolucizumab 6 mg Non-loading n=27 Participants One initial injection followed by treatment every 12 weeks	Total n=52 Participants Total of all reporting groups
Age, Continuous	77.6 years STANDARD_DEVIATION 6.3 • n=99 Participants	77.4 years STANDARD_DEVIATION 8.3 • n=107 Participants	77.5 years STANDARD_DEVIATION 7.3 • n=206 Participants
Sex: Female, Male Female	14 Participants n=99 Participants	18 Participants n=107 Participants	32 Participants n=206 Participants
Sex: Female, Male Male	11 Participants n=99 Participants	9 Participants n=107 Participants	20 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) White	25 Participants n=99 Participants	27 Participants n=107 Participants	52 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants

PRIMARY outcome

Timeframe: Baseline, Week 40 to Week 52

Population: full analysis set - included all patients with a valid assessment without a protocol deviation with impact

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg Loading n=25 Participants 3 x 4-weekly initial injections followed by an injection every 12 weeks	Brolucizumab 6 mg Non-loading n=26 Participants One initial injection followed by treatment every 12 weeks
Week 40 to Week 52: LS Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye Week 40	3.24 Letters read Standard Error 1.32	-0.50 Letters read Standard Error 1.28
Week 40 to Week 52: LS Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye Week 44	3.88 Letters read Standard Error 1.66	-0.27 Letters read Standard Error 1.60
Week 40 to Week 52: LS Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye Week 48	3.12 Letters read Standard Error 1.71	-2.23 Letters read Standard Error 1.65
Week 40 to Week 52: LS Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye Week 52	2.76 Letters read Standard Error 1.64	-1.43 Letters read Standard Error 1.58

SECONDARY outcome

Timeframe: -24 Weeks, Baseline, Week 52

Population: full analysis set

Treatment interval distribution. Treatment interval during the study, within 24 weeks prior to baseline and interval between the last 2 injections in the study. In the loading arm, data from the loading period was excluded.

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg Loading n=25 Participants 3 x 4-weekly initial injections followed by an injection every 12 weeks	Brolucizumab 6 mg Non-loading n=27 Participants One initial injection followed by treatment every 12 weeks
Treatment Intervals Before and During the Study within 24 weeks prior to baseline	54.7 days Interval 40.0 to 152.0	68.5 days Interval 37.2 to 165.0
Treatment Intervals Before and During the Study from baseline to week 52 (n=23,25)	64.8 days Interval 47.5 to 85.3	77.8 days Interval 55.8 to 85.8
Treatment Intervals Before and During the Study Last treatment interval during the study (n=25,25)	56.0 days Interval 28.0 to 88.0	65.0 days Interval 56.0 to 91.0

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: full analysis set - included all patients with a valid assessment without a protocol deviation with impact

Treatment interval distribution. Prolongation was calculated by comparing the mean treatment interval in last 24 weeks prior to first brolucizumab injection (a) with the mean of the average treatment interval during the study (loading phase excluded in the loading arm) and (b) with the last treatment interval during the study. Patients with only 1 injection during the treatment period were calculated as non-responders (no prolon-gation).

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg Loading n=25 Participants 3 x 4-weekly initial injections followed by an injection every 12 weeks	Brolucizumab 6 mg Non-loading n=27 Participants One initial injection followed by treatment every 12 weeks
Number of Patients With Prolonged Interval from baseline to week 52	18 Participants	12 Participants
Number of Patients With Prolonged Interval Last treatment interval during the study	13 Participants	10 Participants

SECONDARY outcome

Timeframe: Up to week 52

Population: full analysis set

Treatment interval distribution up to Week 52. Proportion of patients maintained on q12w treatment frequency in the two brolucizumab groups up to week 52. Patients who discontinued treatment before week 52 were rated as non-responders, i.e., as patients who did not maintain the q12w regimen. In the loading arm, the loading period up to week 12 was not considered in the analysis.

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg Loading n=25 Participants 3 x 4-weekly initial injections followed by an injection every 12 weeks	Brolucizumab 6 mg Non-loading n=27 Participants One initial injection followed by treatment every 12 weeks
Proportion of Patients Who Maintained on q12w Regimen.	8 Participants	6 Participants

SECONDARY outcome

Timeframe: Up to Week 52

Population: full analysis set

Treatment interval distribution

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg Loading n=25 Participants 3 x 4-weekly initial injections followed by an injection every 12 weeks	Brolucizumab 6 mg Non-loading n=27 Participants One initial injection followed by treatment every 12 weeks
Distribution of Patients at Every 8 Weeks / Every 12 Weeks Intervals - Frequency of Switches in Treatment Intervals Between Baseline and Week 52 Switch q12w to q8w (overall)	15 Participants	19 Participants
Distribution of Patients at Every 8 Weeks / Every 12 Weeks Intervals - Frequency of Switches in Treatment Intervals Between Baseline and Week 52 Switch q8w to q12w (overall)	3 Participants	6 Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 16 to 28, Week 52

Population: full analysis set

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg Loading n=25 Participants 3 x 4-weekly initial injections followed by an injection every 12 weeks	Brolucizumab 6 mg Non-loading n=27 Participants One initial injection followed by treatment every 12 weeks
Mean Change in Best-corrected Visual Acuity Baseline	72.0 Letters read Standard Deviation 8.7	71.6 Letters read Standard Deviation 11.5
Mean Change in Best-corrected Visual Acuity Mean of weeks 16 to 28	74.9 Letters read Standard Deviation 9.2	71.2 Letters read Standard Deviation 12.9
Mean Change in Best-corrected Visual Acuity Week 52	74.8 Letters read Standard Deviation 9.1	69.8 Letters read Standard Deviation 16.1

SECONDARY outcome

Timeframe: Baseline, up to Week 52

Population: full analysis set

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg Loading n=25 Participants 3 x 4-weekly initial injections followed by an injection every 12 weeks	Brolucizumab 6 mg Non-loading n=27 Participants One initial injection followed by treatment every 12 weeks
Number of Patients With Best-corrected Visual Acuity Improvements of >= 5, >= 10 and >= 15 Letters BCVA ≥ 5 ETDRS letters improvement during the study	9 Participants	5 Participants
Number of Patients With Best-corrected Visual Acuity Improvements of >= 5, >= 10 and >= 15 Letters BCVA ≥ 10 ETDRS letters improvement during the study	2 Participants	2 Participants
Number of Patients With Best-corrected Visual Acuity Improvements of >= 5, >= 10 and >= 15 Letters BCVA ≥ 15 ETDRS letters improvement during the study	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, up to Week 52

Population: full analysis set

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg Loading n=25 Participants 3 x 4-weekly initial injections followed by an injection every 12 weeks	Brolucizumab 6 mg Non-loading n=27 Participants One initial injection followed by treatment every 12 weeks
Number of Patients With Best-corrected Visual Acuity >= 69 Letters	20 Participants	19 Participants

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: full analysis set - included all patients with a valid assessment without a protocol deviation with impact

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg Loading n=25 Participants 3 x 4-weekly initial injections followed by an injection every 12 weeks	Brolucizumab 6 mg Non-loading n=26 Participants One initial injection followed by treatment every 12 weeks
LS Mean Change in Best-corrected Visual Acuity From Baseline at Week 52	2.76 Letters read Standard Error 1.64	-1.43 Letters read Standard Error 1.58

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 16, 28 and 52

Population: full analysis set

Change in central subfield thickness was measured by Spectral domain optical coherence tomography.

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg Loading n=25 Participants 3 x 4-weekly initial injections followed by an injection every 12 weeks	Brolucizumab 6 mg Non-loading n=27 Participants One initial injection followed by treatment every 12 weeks
Change in Central Subfield Thickness From Baseline at Weeks 12, 16, 28 and 52 Week 12	-74.0 µm Interval -275.0 to 27.0	-8.5 µm Interval -232.0 to 650.0
Change in Central Subfield Thickness From Baseline at Weeks 12, 16, 28 and 52 Week 16	-20.0 µm Interval -240.0 to 208.0	-51.0 µm Interval -317.0 to 80.0
Change in Central Subfield Thickness From Baseline at Weeks 12, 16, 28 and 52 Week 28	-21.0 µm Interval -273.0 to 393.0	-53.0 µm Interval -357.0 to 60.0
Change in Central Subfield Thickness From Baseline at Weeks 12, 16, 28 and 52 Week 52	-15.0 µm Interval -268.0 to 269.0	-49.5 µm Interval -359.0 to 30.0

SECONDARY outcome

Timeframe: Every 4 weeks from baseline up to Week 52

Population: full analysis set

Change in fluids was measured by Spectral domain optical coherence tomography.

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg Loading n=25 Participants 3 x 4-weekly initial injections followed by an injection every 12 weeks	Brolucizumab 6 mg Non-loading n=27 Participants One initial injection followed by treatment every 12 weeks
Absence of Intraretinal Fluid in the Central Subfield Baseline	13 Participants	16 Participants
Absence of Intraretinal Fluid in the Central Subfield Week 4	19 Participants	22 Participants
Absence of Intraretinal Fluid in the Central Subfield Week 8	17 Participants	16 Participants
Absence of Intraretinal Fluid in the Central Subfield Week 12	21 Participants	16 Participants
Absence of Intraretinal Fluid in the Central Subfield Week 16	12 Participants	21 Participants
Absence of Intraretinal Fluid in the Central Subfield Week 20	16 Participants	20 Participants
Absence of Intraretinal Fluid in the Central Subfield Week 24	17 Participants	18 Participants
Absence of Intraretinal Fluid in the Central Subfield Week 28	16 Participants	20 Participants
Absence of Intraretinal Fluid in the Central Subfield Week 32	18 Participants	17 Participants
Absence of Intraretinal Fluid in the Central Subfield Week 36	17 Participants	17 Participants
Absence of Intraretinal Fluid in the Central Subfield Week 40	16 Participants	21 Participants
Absence of Intraretinal Fluid in the Central Subfield Week 44	16 Participants	19 Participants
Absence of Intraretinal Fluid in the Central Subfield Week 48	19 Participants	19 Participants
Absence of Intraretinal Fluid in the Central Subfield Week 52	16 Participants	21 Participants

SECONDARY outcome

Timeframe: Every 4 weeks from baseline up to Week 52

Population: full analysis set

Change in fluids was measured by Spectral domain optical coherence tomography.

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg Loading n=25 Participants 3 x 4-weekly initial injections followed by an injection every 12 weeks	Brolucizumab 6 mg Non-loading n=27 Participants One initial injection followed by treatment every 12 weeks
Absence of Subretinal Fluid in the Central Subfield Week 36	11 Participants	14 Participants
Absence of Subretinal Fluid in the Central Subfield Baseline	5 Participants	6 Participants
Absence of Subretinal Fluid in the Central Subfield Week 4	13 Participants	18 Participants
Absence of Subretinal Fluid in the Central Subfield Week 8	18 Participants	12 Participants
Absence of Subretinal Fluid in the Central Subfield Week 12	20 Participants	6 Participants
Absence of Subretinal Fluid in the Central Subfield Week 16	8 Participants	15 Participants
Absence of Subretinal Fluid in the Central Subfield Week 20	3 Participants	12 Participants
Absence of Subretinal Fluid in the Central Subfield Week 24	13 Participants	12 Participants
Absence of Subretinal Fluid in the Central Subfield Week 28	9 Participants	13 Participants
Absence of Subretinal Fluid in the Central Subfield Week 32	11 Participants	14 Participants
Absence of Subretinal Fluid in the Central Subfield Week 40	10 Participants	15 Participants
Absence of Subretinal Fluid in the Central Subfield Week 44	8 Participants	10 Participants
Absence of Subretinal Fluid in the Central Subfield Week 48	10 Participants	15 Participants
Absence of Subretinal Fluid in the Central Subfield Week 52	9 Participants	16 Participants

SECONDARY outcome

Timeframe: Every 4 weeks from baseline up to Week 52

Population: full analysis set

Change in fluids was measured by Spectral domain optical coherence tomography.

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg Loading n=25 Participants 3 x 4-weekly initial injections followed by an injection every 12 weeks	Brolucizumab 6 mg Non-loading n=27 Participants One initial injection followed by treatment every 12 weeks
Absence of Sub-retinal Pigment Epithelium Fluid in the Central Subfield Baseline	15 Participants	13 Participants
Absence of Sub-retinal Pigment Epithelium Fluid in the Central Subfield Week 4	20 Participants	21 Participants
Absence of Sub-retinal Pigment Epithelium Fluid in the Central Subfield Week 8	18 Participants	16 Participants
Absence of Sub-retinal Pigment Epithelium Fluid in the Central Subfield Week 12	20 Participants	17 Participants
Absence of Sub-retinal Pigment Epithelium Fluid in the Central Subfield Week 16	20 Participants	14 Participants
Absence of Sub-retinal Pigment Epithelium Fluid in the Central Subfield Week 20	17 Participants	16 Participants
Absence of Sub-retinal Pigment Epithelium Fluid in the Central Subfield Week 24	18 Participants	16 Participants
Absence of Sub-retinal Pigment Epithelium Fluid in the Central Subfield Week 28	19 Participants	21 Participants
Absence of Sub-retinal Pigment Epithelium Fluid in the Central Subfield Week 32	19 Participants	20 Participants
Absence of Sub-retinal Pigment Epithelium Fluid in the Central Subfield Week 36	18 Participants	19 Participants
Absence of Sub-retinal Pigment Epithelium Fluid in the Central Subfield Week 40	22 Participants	18 Participants
Absence of Sub-retinal Pigment Epithelium Fluid in the Central Subfield Week 44	18 Participants	18 Participants
Absence of Sub-retinal Pigment Epithelium Fluid in the Central Subfield Week 48	21 Participants	18 Participants
Absence of Sub-retinal Pigment Epithelium Fluid in the Central Subfield Week 52	17 Participants	16 Participants

SECONDARY outcome

Timeframe: At Week 52

Population: full analysis set

Presence of active choroidal neovascularization leakage was measured by Fluorescein angiography. CNV = choroidal neovascularization; MNV = macular neovascularization

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg Loading n=25 Participants 3 x 4-weekly initial injections followed by an injection every 12 weeks	Brolucizumab 6 mg Non-loading n=27 Participants One initial injection followed by treatment every 12 weeks
Presence of Active Choroidal Neovascularization Leakage CNV location at week 52 - Missing	1 Participants	2 Participants
Presence of Active Choroidal Neovascularization Leakage Active CNV leakage at week 52 - Yes	17 Participants	15 Participants
Presence of Active Choroidal Neovascularization Leakage Active CNV leakage at week 52 - No	7 Participants	10 Participants
Presence of Active Choroidal Neovascularization Leakage Active CNV leakage at week 52 - missing	1 Participants	2 Participants
Presence of Active Choroidal Neovascularization Leakage CNV location at week 52 - Subfoveal	11 Participants	10 Participants
Presence of Active Choroidal Neovascularization Leakage CNV location at week 52 - Extrafoveal	6 Participants	5 Participants
Presence of Active Choroidal Neovascularization Leakage CNV location at week 52 - Not applicable	7 Participants	10 Participants
Presence of Active Choroidal Neovascularization Leakage CNV subtype at week 52 - Type 1 MNV	12 Participants	9 Participants
Presence of Active Choroidal Neovascularization Leakage CNV subtype at week 52 - Mixed type 1 and type 2 MNV	2 Participants	1 Participants
Presence of Active Choroidal Neovascularization Leakage CNV subtype at week 52 -Type 3 MNV	3 Participants	5 Participants
Presence of Active Choroidal Neovascularization Leakage CNV subtype at week 52 - Not applicable	7 Participants	10 Participants
Presence of Active Choroidal Neovascularization Leakage CNV subtype at week 52 - Missing	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.

Population: safety analysis set

An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. Treatment-emergent AEs are AEs that developed on or after first study treatment administration, or any event previously present that worsened following exposure to the study treatment.

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg Loading n=25 Participants 3 x 4-weekly initial injections followed by an injection every 12 weeks	Brolucizumab 6 mg Non-loading n=27 Participants One initial injection followed by treatment every 12 weeks
Overview of TEAEs Any AE	23 Participants	26 Participants
Overview of TEAEs Ocular AE(s) in the study eye	17 Participants	19 Participants
Overview of TEAEs Ocular AE(s) in the fellow eye	4 Participants	9 Participants
Overview of TEAEs Non-ocular AE(s)	20 Participants	19 Participants
Overview of TEAEs AE(s) related to injection procedure	11 Participants	12 Participants
Overview of TEAEs AE(s) related to study drug	9 Participants	12 Participants
Overview of TEAEs SAE(s)	5 Participants	6 Participants
Overview of TEAEs Ocular SAE(s) in the study eye	1 Participants	4 Participants
Overview of TEAEs Non-ocular SAE(s)	4 Participants	2 Participants
Overview of TEAEs Death	0 Participants	1 Participants
Overview of TEAEs Non-fatal SAE(s)	5 Participants	6 Participants
Overview of TEAEs Discontinuation of study treatment due to any AE(s)	2 Participants	5 Participants
Overview of TEAEs Discontinuation of study treatment due to non-serious AE(s)	0 Participants	4 Participants
Overview of TEAEs Discontinuation of study treatment due to any SAE(s)	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.

Population: safety analysis set

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg Loading n=25 Participants 3 x 4-weekly initial injections followed by an injection every 12 weeks	Brolucizumab 6 mg Non-loading n=27 Participants One initial injection followed by treatment every 12 weeks
Ocular TEAEs in the Study Eye by Primary System Organ Class Total	17 Participants	19 Participants
Ocular TEAEs in the Study Eye by Primary System Organ Class Eye disorders	16 Participants	17 Participants
Ocular TEAEs in the Study Eye by Primary System Organ Class General disorders and administration site conditions	0 Participants	1 Participants
Ocular TEAEs in the Study Eye by Primary System Organ Class Infections and infestations	2 Participants	2 Participants
Ocular TEAEs in the Study Eye by Primary System Organ Class Injury, poisoning and procedural complications	2 Participants	1 Participants
Ocular TEAEs in the Study Eye by Primary System Organ Class Investigations	2 Participants	4 Participants

SECONDARY outcome

Timeframe: Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.

Population: safety analysis set

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg Loading n=25 Participants 3 x 4-weekly initial injections followed by an injection every 12 weeks	Brolucizumab 6 mg Non-loading n=27 Participants One initial injection followed by treatment every 12 weeks
Ocular TEAEs in the Study Eye by Preferred Term (at Least 5% in Any Group) Conjunctival haemorrhage	7 Participants	5 Participants
Ocular TEAEs in the Study Eye by Preferred Term (at Least 5% in Any Group) Visual acuity reduced	2 Participants	3 Participants
Ocular TEAEs in the Study Eye by Preferred Term (at Least 5% in Any Group) Eye inflammation	1 Participants	3 Participants
Ocular TEAEs in the Study Eye by Preferred Term (at Least 5% in Any Group) Intraocular pressure increased	1 Participants	3 Participants
Ocular TEAEs in the Study Eye by Preferred Term (at Least 5% in Any Group) Retinal oedema	1 Participants	3 Participants
Ocular TEAEs in the Study Eye by Preferred Term (at Least 5% in Any Group) Dry Eye	1 Participants	2 Participants
Ocular TEAEs in the Study Eye by Preferred Term (at Least 5% in Any Group) Neovascular age-related macular degeneration	1 Participants	2 Participants
Ocular TEAEs in the Study Eye by Preferred Term (at Least 5% in Any Group) Vitreous detachment	2 Participants	1 Participants
Ocular TEAEs in the Study Eye by Preferred Term (at Least 5% in Any Group) Cataract	0 Participants	2 Participants
Ocular TEAEs in the Study Eye by Preferred Term (at Least 5% in Any Group) Conjunctivitis	0 Participants	2 Participants
Ocular TEAEs in the Study Eye by Preferred Term (at Least 5% in Any Group) Retinal exudates	0 Participants	2 Participants
Ocular TEAEs in the Study Eye by Preferred Term (at Least 5% in Any Group) Vitreous floaters	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.

Population: safety analysis set

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg Loading n=25 Participants 3 x 4-weekly initial injections followed by an injection every 12 weeks	Brolucizumab 6 mg Non-loading n=27 Participants One initial injection followed by treatment every 12 weeks
Non-ocular TEAEs - Total	20 Participants	19 Participants

SECONDARY outcome

Timeframe: Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.

Population: safety analysis set

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg Loading n=25 Participants 3 x 4-weekly initial injections followed by an injection every 12 weeks	Brolucizumab 6 mg Non-loading n=27 Participants One initial injection followed by treatment every 12 weeks
Ocular TEAEs in the Study Eye of Moderate or Severe Intensity Eye inflammation - severe intensity	1 Participants	1 Participants
Ocular TEAEs in the Study Eye of Moderate or Severe Intensity Intraocular pressure increased - severe intensity	0 Participants	1 Participants
Ocular TEAEs in the Study Eye of Moderate or Severe Intensity Retinal haemorrhage - severe intensity	0 Participants	1 Participants
Ocular TEAEs in the Study Eye of Moderate or Severe Intensity Retinal neovascularization - severe intensity	0 Participants	1 Participants
Ocular TEAEs in the Study Eye of Moderate or Severe Intensity Visual acuity reduced - severe intensity	0 Participants	1 Participants
Ocular TEAEs in the Study Eye of Moderate or Severe Intensity Any AE of moderate intensity	3 Participants	8 Participants
Ocular TEAEs in the Study Eye of Moderate or Severe Intensity Cataract - moderate intensity	0 Participants	2 Participants
Ocular TEAEs in the Study Eye of Moderate or Severe Intensity Conjunctival haemorrhage - moderate intensity	0 Participants	1 Participants
Ocular TEAEs in the Study Eye of Moderate or Severe Intensity Conjunctival irritation - moderate intensity	1 Participants	0 Participants
Ocular TEAEs in the Study Eye of Moderate or Severe Intensity Conjunctivitis allergic - moderate intensity	0 Participants	1 Participants
Ocular TEAEs in the Study Eye of Moderate or Severe Intensity Dry eye - moderate intensity	1 Participants	1 Participants
Ocular TEAEs in the Study Eye of Moderate or Severe Intensity Eye inflammation - moderate intensity	0 Participants	1 Participants
Ocular TEAEs in the Study Eye of Moderate or Severe Intensity Eye pain - moderate intensity	0 Participants	1 Participants
Ocular TEAEs in the Study Eye of Moderate or Severe Intensity Neovascular age-related macular degeneration - moderate intensity	0 Participants	1 Participants
Ocular TEAEs in the Study Eye of Moderate or Severe Intensity Retinal vasculitis - moderate intensity	0 Participants	2 Participants
Ocular TEAEs in the Study Eye of Moderate or Severe Intensity Subretinal fluid - moderate intensity	0 Participants	1 Participants
Ocular TEAEs in the Study Eye of Moderate or Severe Intensity Visual acuity reduced - moderate intensity	1 Participants	0 Participants
Ocular TEAEs in the Study Eye of Moderate or Severe Intensity Vital dye staining cornea present - moderate intensity	0 Participants	1 Participants
Ocular TEAEs in the Study Eye of Moderate or Severe Intensity Vitreous opacities - moderate intensity	0 Participants	1 Participants
Ocular TEAEs in the Study Eye of Moderate or Severe Intensity Any AE of severe intensity	1 Participants	2 Participants
Ocular TEAEs in the Study Eye of Moderate or Severe Intensity Endophthalmitis - severe intensity	1 Participants	0 Participants

POST_HOC outcome

Timeframe: Fatality data are reported from first dose of study treatment until approximately Week 52.

Population: safety analysis set

On-treatment deaths are reported from first dose of study treatment until end of study treatment plus 30 days after last treatment, up to a maximum timeframe of approximately 52 weeks. Post-treatment death data are reported from day 31 after last treatment to end of study (Week 52).

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg Loading n=25 Participants 3 x 4-weekly initial injections followed by an injection every 12 weeks	Brolucizumab 6 mg Non-loading n=27 Participants One initial injection followed by treatment every 12 weeks
All Collected Deaths On-treatment Deaths	0 Participants	0 Participants
All Collected Deaths Post-treatment Deaths	0 Participants	1 Participants
All Collected Deaths Total Deaths	0 Participants	1 Participants

Adverse Events

Brolucizumab 6 mg Loading

Serious events: 5 serious events

Other events: 23 other events

Deaths: 0 deaths

Brolucizumab 6 mg Non-loading

Serious events: 6 serious events

Other events: 26 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

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

Measure	Brolucizumab 6 mg Loading n=25 participants at risk 3 x 4-weekly initial injections followed by an injection every 12 weeks	Brolucizumab 6 mg Non-loading n=27 participants at risk One initial injection followed by treatment every 12 weeks
Eye disorders Eye inflammation- Study Eye	4.0% 1/25 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.	3.7% 1/27 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.
Eye disorders Iridocyclitis- Study Eye	0.00% 0/25 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.	3.7% 1/27 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.
Eye disorders Retinal haemorrhage- Study Eye	0.00% 0/25 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.	3.7% 1/27 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.
Eye disorders Retinal neovascularisation- Study Eye	0.00% 0/25 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.	3.7% 1/27 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.
Eye disorders Retinal vasculitis- Study Eye	0.00% 0/25 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.	3.7% 1/27 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.
Eye disorders Visual acuity reduced- Study Eye	0.00% 0/25 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.	3.7% 1/27 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.
Gastrointestinal disorders Colitis ischaemic	0.00% 0/25 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.	3.7% 1/27 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.
Gastrointestinal disorders Diverticulum intestinal	0.00% 0/25 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.	3.7% 1/27 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/25 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.	3.7% 1/27 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.
General disorders Pyrexia	0.00% 0/25 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.	3.7% 1/27 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.
Infections and infestations Endophthalmitis- Study Eye	4.0% 1/25 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.	0.00% 0/27 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.
Infections and infestations Kidney infection	0.00% 0/25 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.	3.7% 1/27 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.
Infections and infestations Urosepsis	0.00% 0/25 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.	3.7% 1/27 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.
Investigations Intraocular pressure increased- Study Eye	0.00% 0/25 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.	3.7% 1/27 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/25 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.	3.7% 1/27 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chromophobe renal cell carcinoma	4.0% 1/25 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.	0.00% 0/27 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm	4.0% 1/25 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.	0.00% 0/27 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.
Nervous system disorders Ballismus	4.0% 1/25 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.	0.00% 0/27 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.
Nervous system disorders Cerebrovascular accident	4.0% 1/25 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.	0.00% 0/27 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.
Renal and urinary disorders Hydronephrosis	0.00% 0/25 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.	3.7% 1/27 • Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.