NCT02705274

PRP vs Bevacizumab for PDR Treatment

Panretinal Photocoagulation Versus Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Marashi Eye Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Protocol S by DRCR.net has shown that receive Ranibizumab as anti-vascular endothelial growth factor (anti-VEGF) therapy with deferred panretinal photocoagulation (PRP) are non-inferior to those in eyes that receive standard prompt PRP therapy, however with some visual functional benefits and less complications with Ranibizumab arm. Applying Protocol S in real world scenario may add cost burden to the patient as patients need about 7 injections per year which will cost the patient about 7000 US dollars a year as minimum The primary objective of this protocol is to determine the visual acuity outcomes at 1 year in eyes with proliferative diabetic retinopathy (PDR) using Bevacizumab 1.25 mg instead of Ranbizumab to lower the cost burden

Conditions

• Proliferative Diabetic Retinopathy

Interventions

Type	Name	Description
DRUG	Bevacizumab	Drug: 1.25-mg Bevacizumab Intravitreal injection of 1.25 mg Bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria. Other: Deferred panretinal photocoagulation PRP is deferred until failure/futility criteria for intravitreal injection are met.
PROCEDURE	Panretinal photocoagulation	Panretinal photocoagulation (full session completed within 42 days).

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-04-01
• Completion: 2017-05-01
• First posted: 2016-03-10
• Last updated: 2017-07-06

Locations

1 site across 1 country: Syria