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)

Multicenter Randomized Open-label Three-arms Controlled 12 Months Clinical Proof of Concept Study to Evaluate Efficacy and Safety of Ranibizumab Alone or in Combination With Laser Photocoagulation vs. Laser Photocoagulation Alone in Proliferative Diabetic Retinopathy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

A 12-month core phase was followed by a 12-month observational follow-up phase (physician's routine), for a planned individual study duration of 24-25 months. A separate informed consent was signed for the 12-month observational follow-up phase. This study was conducted in Germany.

Conditions

• Proliferative Diabetic Retinopathy (PDR)

Interventions

Type	Name	Description
DRUG	Ranibizumab 0.5 mg	Pre-filled syringe for intravitreal injection
PROCEDURE	Panretinal laser photocoagulation	PRP treatment following DRS guidelines

Timeline

• Start date: 2012-12-11
• Primary completion: 2016-11-30
• Completion: 2017-12-05
• First posted: 2012-05-09
• Last updated: 2019-03-15
• Results posted: 2019-03-15

Locations

23 sites across 1 country: Germany