drugset / Trial / NCT04278417

Study of Efficacy and Safety of Brolucizumab Versus Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy

NCT04278417 ↗

Phase 3 Completed 689 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2020-11-19
Primary completion
2023-10-30
Completion
2024-08-19

Outcome

Met primary endpoint

paper Brolucizumab, 6 mg, was noninferior and superior to PRP for BCVA change at week 54 PMID 42024409 ↗

paper least-squares mean [SE] change in letter score: 0.2 [0.72] vs -4.2 [0.73]; difference, 4.4; 95% CI, 2.4-6.4; P < .001 PMID 42024409 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Brolucizumab Other / unclassified 6 mg Intravitreal