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M. S. Ip, Diabetic Retinopathy Clinical Research Network; A Randomized Trial Comparing Intravitreal Triamcinolone Acetonide and Laser Photocoagulation for Diabetic Macular Edema (DME): Study Design and Baseline Characteristics. Invest. Ophthalmol. Vis. Sci. 2008;49(13):3468.
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To evaluate any race or age-related differences in baseline demographic, systemic, and ocular characteristics of participants in this DRCR.net protocol and to compare this cohort with other cohorts enrolled in phase 3 clinical trials for diabetic retinopathy (DR).
Three year, randomized, controlled, multicenter clinical trial including 693 participants enrolled at 88 clinical sites in the United States. Eligibility criteria included center-involved DME and a visual acuity (VA) letter score with a Snellen equivalent of 20/40 to 20/320 inclusive. At baseline, participants provided demographic and systemic data and underwent VA and ophthalmic examination, color fundus photographs and optical coherence tomography. Images were evaluated by a central reading center. Participants were evaluated in one of three age groups: 18 to <60 (A), 60 to <70 (B), and ≥70 (C) and by self-reported race/ethnicity.
Mean age of subjects was 63 years and 72% were white. Older participants were more likely to have type 2 diabetes mellitus (98% Group C vs. 90% Group A) and longer disease duration (duration ≥20 yr: 47% Group C vs. 29% Group A). The most frequent levels of DR among 840 study eyes were moderate (level 43) to moderately severe (level 47) non-proliferative disease (54% of cohort). Milder stages of retinopathy (84% without PDR Group C vs. 67% Group A) and lesser areas of macular edema (median: 3.9 disc areas (DA) vs. 7.9 DA) were present in older (C) vs. younger participants (A). Median VA letter score was 62 (20/63). Mean HbA1c was 7.9%. Median central subfield thickness from Zeiss Stratus OCT3 was 401 microns.
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