CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 689 enrolled
Drug / intervention
Brolucizumab 6 mg +1 morebiological
Likely dose
Brolucizumab 6 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04278417
NCT04278417Phase 3Completed
CompareCT.gov

A 96-week, Two-arm, Randomized, Single-masked, Multi-center, Phase III Study Assessing the Efficacy and Safety of Brolucizumab 6 mg Compared to Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy

Novartis Pharmaceuticals·interventional·Posted Feb 20, 2020·Updated Oct 16, 2025

In Brief

A Phase 3 clinical trial evaluating Brolucizumab 6 mg and Panretinal photocoagulation laser for Proliferative Diabetic Retinopathy. Completed, enrolled 689 participants across 120 sites in 16 countries.

Detailed Summary

The purpose of this study was to evaluate the efficacy and safety of brolucizumab compared to panretinal photocoagulation laser (PRP) in patients with proliferative diabetic retinopathy (PDR). This evaluation will provide information that brolucizumab is non-inferior to PRP with respect to the change in best corrected visual acuity at Week 54.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProliferative Diabetic Retinopathy
CountriesArgentina, Australia, Brazil, Canada, Chile, China, India, Japan, Mexico, Philippines, Puerto Rico, Russia, South Korea, Taiwan, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedFeb 20, 2020
Enrollment StartNov 19, 2020
Primary CompletionOct 30, 2023
Study CompletionAug 19, 2024
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 6.4 years ago

Interventions

Brolucizumab 6 mgbiological

3 x q6w loading injections, followed by q12w maintenance through Week 90

Panretinal photocoagulation laserprocedure

initial treatment in 1-4 sessions up to Week 12, followed with additional PRP treatment as needed