Heier JS, Korobelnik JF, Brown DM, et al.
体腔 黄斑 阿司匹林
目的：旨在比较玻璃体内阿立哌唑注射（IAI）与黄斑激光光凝治疗糖尿病性黄斑水肿（DME）的3年疗效和安全性。设计：两项设计类似的3期试验：VISTA（DME）和VIVID（DME）。研究对象：中心DME患者（眼; n = 872）。眼每4周IAI 2mg（2q4），5个月后每8周IAI 2mg（2q8）或激光对照。第24周起，如果符合挽救治疗标准，IAI患者接受活动性激光治疗，激光对照患者接受IAI 2q8治疗。第100周起，未接受IAI挽救治疗的激光对照患者根据再治疗标准需要接受IAI治疗。主要预后指标：主要终点指标是第52周时的相对于基线的最佳矫正视力（BCVA）变化。结果：VISTA研究中，IAI 2q4，IAI 2q8和激光对照从基线到第148周的平均BCVA增加10.4,10.5和1.4个字母（P <0.0001），VIVID平均BCVA增加10.3,11.7和1.6个字母（P <0.0001）。VISTA研究中，148周时与基线相比，视力增加≥15个字母的眼比例分别为42.9％，35.8％和13.6％（P <0.0001），而VIVID研究中这一指标分别为41.2％，42.2％和18.9％（P <0.0001） 。与激光对照治疗组眼相比，VISTA（29.9％和34.4％：20.1％[P = 0.0350]），IAI 2q4; P = 0.0052，IAI 2q8]）和VIVID（44.3％和47.8％：17.4％[两者P <0.0001]）IAI 2q4和IAI 2q8治疗组糖尿病性视网膜病变严重度量表（DRSS）改善≥2级眼比例较高。在综合安全性分析中，最常见的眼部严重不良事件是白内障（3.1％，2.1％，2q4,2q8和对照0.3％）。结论： 52周和100周时两种IAI方案（与激光对照相比）观察到视觉改善在148周仍有保持，IAI 2q4组和IAI 2q8组的总体疗效类似。IAI治疗也对DRSS评分具有积极影响。超过148周，不良事件发生率与已知的IAI安全性一致。
PURPOSE:To compare efficacy and safety of intravitreal aflibercept injection (IAI) with macular laser photocoagulation for diabetic macular edema (DME) over 3 years.DESIGN:Two similarly designed phase 3 trials: VISTA(DME) and VIVID(DME).PARTICIPANTS:Patients (eyes; n= 872) with central-involved DME.METHODS:Eyes received IAI 2 mg every 4 weeks (2q4), IAI 2 mg every 8 weeks after 5 monthly doses (2q8), or laser control. From week 24, if rescue treatment criteria were met, IAI patients received active laser, and laser control patients received IAI 2q8. From week 100, laser control patients who had not received IAI rescue treatment received IAI as needed per retreatment criteria.MAIN OUTCOME MEASURES:The primary end point was the change from baseline in best-corrected visual acuity (BCVA) at week 52. We report the 148-week results.RESULTS:Mean BCVA gain from baseline to week 148 with IAI 2q4, IAI 2q8, and laser control was 10.4, 10.5, and 1.4 letters (P < 0.0001) in VISTA and 10.3, 11.7, and 1.6 letters (P < 0.0001) in VIVID, respectively. The proportion of eyes that gained ≥15 letters from baseline at week 148 was 42.9%, 35.8%, and 13.6% (P < 0.0001) in VISTA and 41.2%, 42.2%, and 18.9% (P < 0.0001) in VIVID, respectively. Greater proportions of eyes treated with IAI 2q4 and IAI 2q8 versus those treated with laser control had an improvement of ≥2 steps in the Diabetic Retinopathy Severity Scale (DRSS) score in both VISTA (29.9% and 34.4% vs. 20.1% [P= 0.0350, IAI 2q4; P= 0.0052, IAI 2q8]) and VIVID (44.3% and 47.8% vs. 17.4% [P < 0.0001 for both]). In an integrated safety analysis, the most frequent ocular serious adverse event was cataract (3.1%, 2.1%, 0.3% for 2q4, 2q8, and control).CONCLUSIONS:Visual improvements observed with both IAI regimens (over laser control) at weeks 52 and 100 were maintained at week 148, with similar overall efficacy in the IAI 2q4 and IAI 2q8 groups. Treatment with IAI also had positive effects on the DRSS score. Over 148 weeks, the incidence of adverse events was consistent with the known safety profile of IAI.