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

Summary

The purpose of this study was to evaluate the efficacy and safety of brolucizumab in treatment of patients with macular edema (ME) secondary to central retinal vein occlusion (CRVO).

Timeline

Start

2019-07-03

Primary completion

2021-07-26

Completion

2021-07-26

Outcome

Missed primary endpoint

Stopped: “Study was terminated by sponsor due to increased incidences of adverse events of special interest (intraocular inflammation including retinal vasculitis, and retinal vascular occlusion), in patients dosed every 4 weeks beyond 3 initial doses.”

registry analysis (non-inferiority test); Brolucizumab 6 mg vs Aflibercept 2 mg; p = 0.173; Least Square Mean Difference -2.9 (95% CI -5.2 to -0.5); ANOVA NCT03810313 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Aflibercept	Protein / enzyme biologic	2 mg	Intravitreal
Subject	Brolucizumab	Other / unclassified	6 mg	Intravitreal

Indications