PURPOSE To present the rationale, guidelines, and results of ranibizumab treatment for proliferative diabetic retinopathy (PDR) in Diabetic Retinopathy Clinical Research Network (DRCR.net) Protocol S. DESIGN Post hoc analyses from a randomized clinical trial. PARTICIPANTS Three hundred five participants (394 study eyes) having PDR without prior panretinal photocoagulation (PRP). METHODS Intravitreous ranibizumab (0.5 mg) versus PRP for PDR. Ranbizumab-assigned eyes (n = 191) received monthly injections for 6 months unless resolution was achieved after 4 injections. After 6 months, injections could be deferred if neovascularization was stable over 3 consecutive visits (sustained stability). If neovascularization worsened, monthly treatment resumed. Panretinal photocoagulation could be initiated for failure or futility criteria. MAIN OUTCOME MEASURES Neovascularization status through 2 years. RESULTS At 1 month, 19% (35 of 188) of ranibizumab-assigned eyes showed complete neovascularization resolution and an additional 60% (113) showed improvement. At 6 months, 52% (80 of 153) showed neovascularization resolution, 3% (4) were improved, 37% (56) were stable, and 8% (13) had worsened since the last visit. Among eyes with versus without resolved neovascularization at 6 months, the median (interquartile range) number of injections between 6 months and 2 years was 4 (1-7; n = 73) versus 7 (4-11; n = 67; P < 0.001). Injections were deferred in 68 of 73 eyes (93%) meeting sustained stability at least once during the study; 62% (42 of 68) resumed injections within 16 weeks after deferral. At 2 years, 43% (66 of 154) showed neovascularization resolution, 5% (7) showed improvement, 23% (36) were stable, and 27% (42) had worsened since the last visit. Only 3 eyes met criteria for failure or futility through 2 years. CONCLUSIONS The DRCR.net treatment algorithm for PDR can provide excellent clinical outcomes through 2 years for patients initiating anti-vascular endothelial growth factor (VEGF) therapy for PDR. When choosing between anti-VEGF and PRP as first-line therapy for PDR, treatment decisions should be guided by consideration of the relative advantages of each therapeutic method and anticipated patient compliance with follow-up and treatment recommendations.

中文翻译：

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协议S抗血管内皮生长因子算法在增生性糖尿病视网膜病变中的原理和应用。

目的在糖尿病性视网膜病临床研究网络（DRCR.net）方案S中提出兰尼单抗治疗增生性糖尿病性视网膜病（PDR）的原理，指南和结果。设计来自一项随机临床试验的事后分析。参与者三百零五名参与者（394眼研究者）患有PDR，而无先前的全视网膜光凝（PRP）。方法玻璃体内雷珠单抗（0.5 mg）与PRP相比用于PDR。分配给兰比单抗的眼睛（n = 191）每月应注射6个月，除非4次注射后仍未消退。6个月后，如果连续3次就诊时新血管形成稳定（持续稳定），则可以推迟注射。如果新血管形成恶化，应重新开始每月治疗。可针对失败或无效标准启动全视网膜光凝。主要观察指标持续2年的新血管形成状况。结果在1个月时，分配了兰尼单抗的眼睛中有19％（188个中的35个）显示出完全的新血管形成分辨率，另有60％（113个）显示出了改善。自上次访视以来，在6个月时，有52％（共153个中的80个）显示出新血管形成的分辨率，改善了3％（4），稳定了37％（56），并且有8％（13）恶化了。在6个月有或没有新血管形成的眼中，在6个月至2年之间的中位（四分位间距）注射次数为4（1-7； n = 73）对7（4-11； n = 67； P < 0.001）。在研究期间，在73眼中有68眼（93％）中推迟注射至少达到一次稳定。有62％（68中的42）在延期后的16周内恢复了注射。在2年时，有43％（154人中有66人）表现出新血管形成的消退，自上次造访以来，有5％（7）的病情有所改善，有23％（36）的病情稳定，有27％（42）的病情恶化。在2年内，只有3只眼睛符合失败或徒劳标准。结论针对PDR的DRCR.net治疗算法可以为开始PDR的抗血管内皮生长因子（VEGF）治疗的患者提供长达2年的出色临床效果。在抗VEGF和PRP之间作为PDR的一线治疗药物时，应根据每种治疗方法的相对优势以及预期的患者对随访和治疗建议的依从性来指导治疗决策。针对PDR的净治疗算法可以为开始PDR的抗血管内皮生长因子（VEGF）治疗的患者在2年内提供出色的临床效果。在抗VEGF和PRP之间作为PDR的一线治疗药物时，应根据每种治疗方法的相对优势以及预期的患者对随访和治疗建议的依从性来指导治疗决策。针对PDR的净治疗算法可以为开始PDR的抗血管内皮生长因子（VEGF）治疗的患者在2年内提供出色的临床效果。在抗VEGF和PRP之间作为PDR的一线治疗药物时，应根据每种治疗方法的相对优势以及预期的患者对随访和治疗建议的依从性来指导治疗决策。