玻璃体腔内阿柏西普治疗糖尿病性黄斑水肿：VISTA 和 VIVID 研究的 148 周结果。
Intravitreal Aflibercept for Diabetic Macular Edema: 148-Week Results from the VISTA and VIVID Studies.
机构信息
Ophthalmic Consultants of Boston, Boston, Massachusetts.
Service d'ophtalmologie, CHU de Bordeaux, France; University Bordeaux, ISPED, F-33000 Bordeaux, Bordeaux, France; Inserm, U1219 - Bordeaux Population Health Research Center, F-33000 Bordeaux, France.
出版信息
Ophthalmology. 2016 Nov;123(11):2376-2385. doi: 10.1016/j.ophtha.2016.07.032. Epub 2016 Sep 17.
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 and VIVID.
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.
目的
比较玻璃体内注射阿柏西普（IAI）与黄斑激光光凝治疗糖尿病黄斑水肿（DME）的疗效和安全性，随访时间超过 3 年。
设计
两项类似设计的 3 期试验：VISTA 和 VIVID。
参与者
患有中心性 DME 的患者（眼；n=872）。
方法
眼接受 2 毫克玻璃体内注射 2 毫克每 4 周（2q4），2 毫克玻璃体内注射 2 毫克每 8 周后 5 个月剂量（2q8），或激光对照。从第 24 周开始，如果符合抢救治疗标准，则 IAI 患者接受主动激光治疗，激光对照组患者接受 IAI 2q8。从第 100 周开始，未接受 IAI 抢救治疗的激光对照组患者根据再治疗标准按需接受 IAI。
主要观察指标
主要终点是从基线到第 52 周最佳矫正视力（BCVA）的变化。我们报告了 148 周的结果。
结果
在 VISTA 中，2q4、2q8 和激光对照组的 IAI 从基线到第 148 周的平均 BCVA 增益分别为 10.4、10.5 和 1.4 个字母（P<0.0001），在 VIVID 中分别为 10.3、11.7 和 1.6 个字母（P<0.0001）。在第 148 周，与激光对照组相比，2q4、2q8 和激光对照组的眼从基线获得≥15 个字母的比例分别为 42.9%、35.8%和 13.6%（P<0.0001）在 VISTA 和 41.2%、42.2%和 18.9%（P<0.0001）在 VIVID。与激光对照组相比，接受 2q4 和 2q8 IAI 治疗的眼在 VISTA（29.9%和 34.4%与 20.1%[P=0.0350，2q4 IAI；P=0.0052，2q8 IAI]）和 VIVID（44.3%和 47.8%与 17.4%[均 P<0.0001]）的糖尿病视网膜病变严重程度量表（DRSS）评分中均有≥2 步改善的比例更高。在一项综合安全性分析中，最常见的眼部严重不良事件是白内障（3.1%、2.1%、0.3%分别为 2q4、2q8 和对照组）。
结论
在第 52 周和第 100 周观察到的两种 IAI 方案（与激光对照组相比）的视力改善在第 148 周时得以维持，2q4 和 2q8 组的总体疗效相似。IAI 的治疗也对 DRSS 评分有积极影响。在 148 周内，不良事件的发生率与 IAI 的已知安全性特征一致。
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