Conditions: Proliferative Diabetic Retinopathy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 305
Healthy volunteers: no

Brief summary:
The primary objective of the protocol is to determine if visual acuity outcomes at 2 years in eyes with proliferative diabetic retinopathy (PDR) that receive 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.

Secondary objectives include:

* Comparing other visual function outcomes (including Humphrey visual field testing and study participant self-reports of visual function) in eyes receiving anti-VEGF with deferred PRP with those in eyes receiving prompt PRP.
* Determining percent of eyes not requiring PRP when anti-VEGF is given in the absence of prompt PRP.
* Comparing safety outcomes between treatment groups.
* Comparing associated treatment and follow-up exam costs between treatment groups.

Detailed description:

Arms:
arm 1: Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated. arm 2: PRP= Panretinal Photocoagulation. PRP alone.

Interventions: intervention 1: Prompt Panretinal Photocoagulation intervention 2: 0.5-mg Ranibizumab intervention 3: Deferred panretinal photocoagulation
Intervention descriptions: intervention 1: Panretinal photocoagulation alone at baseline (full session completed within 56 days). intervention 2: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria. intervention 3: PRP is deferred until failure/futility criteria for intravitreal injection are met.

Protocol document: