drugset / Trial / NCT04278417
Study of Efficacy and Safety of Brolucizumab Versus Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Brolucizumab | Other / unclassified | 6 mg | Intravitreal |