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

Conditions

• Central Retinal Vein Occlusion

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Brolucizumab 6 mg — DRUG
  Solution for injection (intravitreal use)
• Aflibercept 2 mg — DRUG
  Solution for injection (Intravitreal use)
• Sham injection — OTHER
  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.

Study Details

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).

Key Dates

Start date

Jul 3, 2019

Status verified

Jan 2023

Primary completion

Jul 26, 2021

Completion

Jul 26, 2021

Study Design

Enrollment

493 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Brolucizumab 6 mg
  1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)
• Active Comparator: Aflibercept 2 mg
  1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)

Primary Outcome Measure

Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 24 [ Time Frame: Baseline, Week 24 ]

Locations (30)

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