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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
305
Panretinal photocoagulation alone at baseline (full session completed within 56 days).
Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
PRP is deferred until failure/futility criteria for intravitreal injection are met.
Retinal Consultants of AZ
Phoenix, Arizona, United States
Loma Linda University Health Care, Dept. of Ophthalmology
Loma Linda, California, United States
Southern California Desert Retina Consultants, MC
Palm Springs, California, United States
California Retina Consultants
Santa Barbara, California, United States
Bay Area Retina Associates
Walnut Creek, California, United States
Mean Change in Visual Acuity From Baseline
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.
Time frame: 2-years
Mean Visual Acuity
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.
Time frame: 2-years
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
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.
Time frame: 2-years
Frequency of Vitrectomy
Time frame: 2-years
Mean Change in OCT Central Subfield Thickness From Baseline
All baseline and 2-year optical coherence tomography (OCT) scans were evaluated by the OCT reading center.
Time frame: 2-years
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
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New England Retina Associates
Trumbull, Connecticut, United States
Retina Consultants of Southwest Florida
Fort Myers, Florida, United States
Central Florida Retina Institute
Lakeland, Florida, United States
Ocala Eye Retina Consultants
Ocala, Florida, United States
Fort Lauderdale Eye Institute
Plantation, Florida, United States
...and 38 more locations