Prompt Panretinal Photocoagulation Versus Ranibizumab+Deferred Panretinal Photocoagulation for Proliferative Diabetic Retinopathy

Conditions

• Proliferative Diabetic Retinopathy

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed

Dec 9, 2011

Start date

Mar 31, 2012

Status verified

Oct 2021

Primary completion

Jan 31, 2015

Completion

Feb 5, 2018

Study Design

Enrollment

305 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

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

Primary Outcome Measure

Mean Change in Visual Acuity From Baseline [ Time Frame: 2-years ]

Locations (48)

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