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Panretinal Photocoagulation vs Intravitreous Ranibizumab for Proliferative Diabetic Retinopathy

作者:Jeffrey G. Gross, Adam R. Glassman, Lee M. Jampol, Seidu Inusah, Lloyd Paul Aiello, Andrew N. Antoszyk, Carl W. Baker, Brian B. Berger, Neil M. Bressler, David J. Browning, Michael J. Elman, Frederick L. Ferris, Scott M. Friedman, Dennis M. Marcus, Michele Melia, Cynthia R. Stockdale, Jennifer K. Sun, Roy W. Beck · 发表于:JAMA · 年份:2015 · DOI:10.1001/jama.2015.15217 · 被引用次数:779 · 研究领域:Retinal Diseases and Treatments、Ocular Diseases and Behçet’s Syndrome、Retinal and Macular Surgery

IMPORTANCE: Panretinal photocoagulation (PRP) is the standard treatment for reducing severe visual loss from proliferative diabetic retinopathy. However, PRP can damage the retina, resulting in peripheral vision loss or worsening diabetic macular edema (DME). OBJECTIVE: To evaluate the noninferiority of intravitreous ranibizumab compared with PRP for visual acuity outcomes in patients with proliferative diabetic retinopathy. DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial conducted at 55 US sites among 305 adults with proliferative diabetic retinopathy enrolled between February and December 2012 (mean age, 52 years; 44% female; 52% white). Both eyes were enrolled for 89 participants (1 eye to each study group), with a total of 394 study eyes. The final 2-year visit was completed in January 2015. INTERVENTIONS: Individual eyes were randomly assigned to receive PRP treatment, completed in 1 to 3 visits (n = 203 eyes), or ranibizumab, 0.5 mg, by intravitreous injection at baseline and as frequently as every 4 weeks based on a structured re-treatment protocol (n = 191 eyes). Eyes in both treatment groups could receive ranibizumab for DME. MAIN OUTCOMES AND MEASURES: The primary outcome was mean visual acuity change at 2 years (5-letter noninferiority margin; intention-to-treat analysis). Secondary outcomes included visual acuity area under the curve, peripheral visual field loss, vitrectomy, DME development, and retinal neovascularization. RESULTS: Mean visual acuity...