drugset / Trial / NCT01594281

Multicenter 12 Months Clinical Study to Evaluate Efficacy and Safety of Ranibizumab Alone or in Combination With Laser Photocoagulation vs. Laser Photocoagulation Alone in Proliferative Diabetic Retinopathy (PRIDE)

NCT01594281 ↗

Phase 2 Completed 107 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study was to assess the efficacy and safety of the anti-Vascular Endothelial Growth Factor (VEGF) agent ranibizumab (0.5 mg) with or without Panretinal laser photocoagulation (PRP) compared to PRP alone in patients with Proliferative Diabetic Retinopathy (PDR).

Timeline

Start
2012-12-11
Primary completion
2016-11-30
Completion
2017-12-05

Outcome

Met primary endpoint

registry analysis (other test); Ranibizumab Mono vs PRP Mono; p = 0.0344; Least Squares Mean Difference -2.8 (95% CI -5.4 to -0.2); ANCOVA NCT01594281 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ranibizumab Monoclonal antibody 0.5 mg Intravitreal