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)

• Status: Completed
• Trial end date: 2017-12-05
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Collaborators: Cologne Image Reading Center & Laboratory (CIRCL); Spranger Laboratories
• Treatments: Ranibizumab

Criteria

Inclusion Criteria:

• Proliferative Diabetic Retinopathy

• Best Corrected Visual Acuity (BCVA) in study eye of at least 20 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (20/400)

• Type 1 or type 2 diabetes under medical surveillance / with stabilized treatment

Exclusion Criteria:

• Proliferative vitreoretinopathy in study eye

• Clinically significant macular edema (CSME) in the study eye

• Clinically non significant macular edema (CNSME) that is likely to develop to CSME in the study eye

• Uncontrolled glaucoma in either eye

• Other protocol-specified conditions