PRP vs Bevacizumab for PDR Treatment

Conditions

• Proliferative Diabetic Retinopathy

Eligibility Criteria

Sex

ALL

Age

18 Years - 99 Years

Healthy Volunteers

Not accepted

Interventions

• Bevacizumab — DRUG
  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.
• Panretinal photocoagulation — PROCEDURE
  Panretinal photocoagulation (full session completed within 42 days).

Study Details

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

Key Dates

First listed

Mar 10, 2016

Start date

Feb 29, 2016

Status verified

Jul 2017

Primary completion

Apr 30, 2017

Completion

May 31, 2017

Study Design

Enrollment

30 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Prompt Panretinal Photocoagulation
  PRP= Panretinal Photocoagulation. PRP alone.
• Experimental: Bevacizumab with deferred PRP
  Bevacizumab = Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.

Primary Outcome Measure

Proportion of visual acuity improvement using Snellen chart or equivalent from baseline and 1 year [ Time Frame: 1 year ]