Trial · NCT03810313

Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion

NCT03810313, Phase 3, Terminated, Novartis Pharmaceuticals; results first posted 2022-08-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion. Trials, record NCT03810313. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03810313

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion
NCT number: NCT03810313
Status: Terminated
Phases: Phase 3
Enrollment: 493 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Central Retinal Vein Occlusion
Interventions: Brolucizumab 6 mg, Aflibercept 2 mg, Sham injection
First posted: 2019-01-18
Last updated: 2023-01-30
Other registries' IDs: eudract:2018-001788-21
Results first posted: 2022-08-08

Source ClinicalTrials.gov

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 24	Baseline, Week 24	BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters. Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning. Missing and censored BCVA values were imputed by Last observation carried forward (LOCF) as the primary approach. Observed values from both scheduled and unscheduled post-baseline visits were used for the LOCF imputation. For subjects with no post-baseline BCVA value, the baseline value was carried forward.
Secondary	Change From Baseline in BCVA Averaged Over Week 40 to Week 52	Baseline, Week 40 to Week 52	An average BCVA over week 40 to week 52 was calculated. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters. Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning.
Secondary	Change From Baseline in BCVA Averaged Over Week 64 to Week 76	Baseline, Week 64 to Week 76	An average BCVA over week 64 to week 76 was calculated. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters. Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning.
Secondary	Change From Baseline in BCVA by Visit up to Week 76	Baseline and every 4 weeks from baseline up to Week 76	BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters. Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning.
Secondary	Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline	Baseline and every 4 weeks from baseline up to Week 76	The summary by visit was conducted based on the BCVA observed from each of the corresponding visits. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters. Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning. Every 5 letters represents 1 line of vision on the reading chart.
Secondary	Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline	Baseline and every 4 weeks from baseline up to Week 76	The summary by visit was conducted based on the BCVA observed from each of the corresponding visit. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters. Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning. Every 5 letters represents 1 line of vision on the reading chart.
Secondary	Change From Baseline in CSFT Averaged Over Week 40 to Week 52	Baseline, Week 40 to Week 52	Change from baseline in central subfield thickness (CSFT) averaged over Week 40 to Week 52, measured in μm by Spectral Domain Optical Coherence Tomography (SD-OCT)
Secondary	Change From Baseline in CSFT Averaged Over Week 64 to Week 76	Baseline, Week 64 to Week 76	Change from baseline in central subfield thickness (CSFT) averaged over Week 64 to Week 76, measured in μm by Spectral Domain Optical Coherence Tomography (SD-OCT)
Secondary	Change From Baseline in CSFT by Visit up to Week 76	Baseline, and every 4 weeks from baseline up to Week 76	Change from baseline in central subfield thickness (CSFT) measured in μm by Spectral Domain Optical Coherence Tomography (SD-OCT)
Secondary	Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76	Every 4 weeks from week 4 up to Week 76	Presence of retinal fluid (intra- and/or subretinal fluid) assessed by Spectral Domain Optical Coherence Tomography (SD-OCT)

1 to 10 of 16Source ClinicalTrials.gov

See all 16 registered outcomes

Outcomes16

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 24	Baseline, Week 24	Full Analysis Set (FAS) included all randomized subjects who received at least one Intravitreal injection of the study treatment.	Letters read	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in BCVA Averaged Over Week 40 to Week 52	Baseline, Week 40 to Week 52	FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment.~The number analyzed per row is the number of subjects from the FAS who had a valid assessment for both baseline and the corresponding post baseline period.	Letters read	MEAN
SECONDARY	Change From Baseline in BCVA Averaged Over Week 64 to Week 76	Baseline, Week 64 to Week 76	FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment.~The number analyzed per row is the number of subjects from the FAS who had a valid assessment for both baseline and the corresponding post baseline period.	Letters read	MEAN
SECONDARY	Change From Baseline in BCVA by Visit up to Week 76	Baseline and every 4 weeks from baseline up to Week 76	FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment.~The number analyzed per row is the number of subjects from the FAS who had a valid assessment for both baseline and the corresponding post baseline visit.	Letters read	MEAN
SECONDARY	Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline	Baseline and every 4 weeks from baseline up to Week 76	FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had a valid assessment for both baseline and the corresponding post baseline visit.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline	Baseline and every 4 weeks from baseline up to Week 76	FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had a valid assessment for both baseline and the corresponding post baseline visit.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline in CSFT Averaged Over Week 40 to Week 52	Baseline, Week 40 to Week 52	FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had at least one CSFT assessment on scheduled visits over the corresponding time point	μm	MEAN
SECONDARY	Change From Baseline in CSFT Averaged Over Week 64 to Week 76	Baseline, Week 64 to Week 76	FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had at least one CSFT assessment on scheduled visits over the corresponding time point	μm	MEAN
SECONDARY	Change From Baseline in CSFT by Visit up to Week 76	Baseline, and every 4 weeks from baseline up to Week 76	FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had CSFT data available on baseline and the specific post-baseline visit.	μm	MEAN
SECONDARY	Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76	Every 4 weeks from week 4 up to Week 76	FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had data at each time point	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 16Source ClinicalTrials.gov

See all 16 outcomes

Results by group466

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 24	Brolucizumab 6 mg		13.2	Standard Error 0.85	Letters read
Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 24	Aflibercept 2 mg		16.0	Standard Error 0.85	Letters read
Change From Baseline in BCVA Averaged Over Week 40 to Week 52	Brolucizumab 6 mg		13.4	Standard Deviation 15.73	Letters read
Change From Baseline in BCVA Averaged Over Week 40 to Week 52	Aflibercept 2 mg		15.4	Standard Deviation 13.96	Letters read
Change From Baseline in BCVA Averaged Over Week 64 to Week 76	Brolucizumab 6 mg		14.0	Standard Deviation 16.39	Letters read
Change From Baseline in BCVA Averaged Over Week 64 to Week 76	Aflibercept 2 mg		16.9	Standard Deviation 13.60	Letters read
Change From Baseline in BCVA by Visit up to Week 76	Brolucizumab 6 mg	Week 4	11.3	Standard Deviation 12.30	Letters read
Change From Baseline in BCVA by Visit up to Week 76	Aflibercept 2 mg	Week 4	12.8	Standard Deviation 11.00	Letters read
Change From Baseline in BCVA by Visit up to Week 76	Brolucizumab 6 mg	Week 8	13.6	Standard Deviation 13.77	Letters read
Change From Baseline in BCVA by Visit up to Week 76	Aflibercept 2 mg	Week 8	15.0	Standard Deviation 11.78	Letters read

1 to 10 of 466Source ClinicalTrials.gov

See all 466 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Brolucizumab 6 mg	247
Overall Study	STARTED	Aflibercept 2 mg	246
Overall Study	COMPLETED	Brolucizumab 6 mg	66
Overall Study	COMPLETED	Aflibercept 2 mg	70
Overall Study	NOT COMPLETED	Brolucizumab 6 mg	181
Overall Study	NOT COMPLETED	Aflibercept 2 mg	176

Source ClinicalTrials.gov

Adverse events249

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Cataract - Study eye	Eye disorders	Brolucizumab 6mg	8	247
other	Cataract - Study eye	Eye disorders	Aflibercept 2mg	4	246
other	Cataract - Study eye	Eye disorders	Overall	12	493
other	Conjunctival haemorrhage - Study eye	Eye disorders	Brolucizumab 6mg	16	247
other	Conjunctival haemorrhage - Study eye	Eye disorders	Aflibercept 2mg	11	246
other	Conjunctival haemorrhage - Study eye	Eye disorders	Overall	27	493
other	Dry eye - Fellow eye	Eye disorders	Brolucizumab 6mg	5	247
other	Dry eye - Fellow eye	Eye disorders	Aflibercept 2mg	5	246
other	Dry eye - Fellow eye	Eye disorders	Overall	10	493
other	Dry eye - Study eye	Eye disorders	Brolucizumab 6mg	6	247

1 to 10 of 249Source ClinicalTrials.gov

See all 249 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Brolucizumab 6mg	2	247
Total, all-cause mortality	Aflibercept 2mg	1	246
Total, all-cause mortality	Overall	3	493
Total, other adverse events	Brolucizumab 6mg	104	247
Total, other adverse events	Aflibercept 2mg	87	246
Total, other adverse events	Overall	191	493
Total, serious adverse events	Brolucizumab 6mg	36	247
Total, serious adverse events	Aflibercept 2mg	19	246
Total, serious adverse events	Overall	55	493

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03810313

GET https://conductscience.org/api/trials/v1/NCT03810313/results?page=2

API reference For AI assistants