Prompt Panretinal Photocoagulation Versus Ranibizumab+Deferred Panretinal Photocoagulation for Proliferative Diabetic Retinopathy (Protocol S)
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.
|Proliferative Diabetic Retinopathy||Other: Prompt Panretinal Photocoagulation Drug: 0.5-mg Ranibizumab Other: Deferred panretinal photocoagulation||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prompt Panretinal Photocoagulation Versus Intravitreal Ranibizumab With Deferred Panretinal Photocoagulation for Proliferative Diabetic Retinopathy|
- Mean Change in Visual Acuity From Baseline [ Time Frame: 2-years ]Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart.
- Mean Visual Acuity [ Time Frame: 2-years ]Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart.
- Number of Eyes With Greater Than or Equal to 10 Letter Vision Gain [ Time Frame: 2-years ]
- Humphrey Visual Field Test Cumulative Score Change From Baseline [ Time Frame: 2-years ]Visual fields, collected using the Humphrey Visual Field analyzer, measured the total point score (sum of retinal sensitivities of all points) tested on 30-2 and 60-4 patterns, which included the mid-peripheral and peripheral visual fields. A lower score indicates greater visual field loss.The cumulative score is the sum of all visual field sensitivity values for each of the four individual quadrants of the visual field (the quadrants are divided by the horizontal and vertical lines). The range can be from 0 to about 600 for the 30-2 test [for each quadrant], and from 0 to about 400 or 450 for the peripheral test.
- Frequency of Vitrectomy [ Time Frame: 2-years ]
- Mean Change in OCT Central Subfield Thickness From Baseline [ Time Frame: 2-years ]All baseline and 2-year optical coherence tomography (OCT) scans were evaluated by the OCT reading center.
- Development of Central DME With Vision Impairment by 2-years [ Time Frame: 2-years ]
- Number of Eyes With Vitreous Hemorrhage [ Time Frame: 2-years ]
- Number of Eyes Without Active or Regressed Neovascularization on Fundus Photography at 2-years [ Time Frame: 2-years ]
- Number of Eyes With Greater Than or Equal to 10 Letter Vision Loss [ Time Frame: 2-year ]
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||December 2017|
|Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Experimental: Anti-VEGF+Deferred PRP
Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.
Drug: 0.5-mg Ranibizumab
Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) 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.
Active Comparator: Prompt PRP
PRP= Panretinal Photocoagulation. PRP alone.
Other: Prompt Panretinal Photocoagulation
Panretinal photocoagulation alone at baseline (full session completed within 56 days).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01489189
Show 48 Study Locations
|Study Chair:||Jeffrey G Gross, MD||Carolina Retina Center|