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

An Eighteen-Month, Two-Arm, Randomized, Double Masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Adult Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 493 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The study included Screening Period (Day -28 to Day -1), double-masked treatment period (Day 1 to Week 72), and post-treatment follow-up period (Week 72 to Week 76). Treatment visits were scheduled in 4-week intervals. After 6 initial monthly injections of brolucizumab or aflibercept (loading phase), subjects entered a one-year individualized flexible treatment (IFT) phase. During the IFT phase, an assessment of disease stability was performed at each monthly visit and subjects received either an active or a sham injection. Treatment with active was interrupted when disease stability was reached.

Conditions

• Central Retinal Vein Occlusion

Interventions

Type	Name	Description
DRUG	Brolucizumab 6 mg	Solution for injection (intravitreal use)
DRUG	Aflibercept 2 mg	Solution for injection (Intravitreal use)
OTHER	Sham injection	Empty sterile syringe without a needle administered as a sham injection for masking. From Week 24 to Week 72 inclusive, a sham treatment was performed to maintain subject masking in case treatment with brolucizumab or aflibercept was not deemed necessary by the investigator.

Timeline

• Start date: 2019-07-03
• Primary completion: 2021-07-26
• Completion: 2021-07-26
• First posted: 2019-01-18
• Last updated: 2023-01-30
• Results posted: 2022-08-08

Locations

120 sites across 20 countries: United States, Australia, Canada, China, Czechia, France, Germany, Greece, Hungary, Israel, Italy, Japan, Malaysia, Netherlands, Puerto Rico, Russia, Spain, Thailand, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study