Do Diana V, Gordon Carmelina, Suñer Ivan J, Reed Kimberly, Moini Hadi, Gibson Andrea, Du Weiming, Shah Chirag P
Byers Eye Institute, Stanford University, Palo Alto, CA, USA.
Specialty Eye Institute, Jackson, MI, USA.
J Vitreoretin Dis. 2022 Jun 4;6(4):295-301. doi: 10.1177/24741264221093914. eCollection 2022 Jul-Aug.
This work aimed to assess the incidence of proliferative diabetic retinopathy (PDR) events and improvement to mild non-PDR (NPDR) or better after intravitreal aflibercept injection (IAI) or laser treatment (control) in diabetic macular edema (DME).
PDR events in the VISTA (NCT01363440) and VIVID (NCT01331681) phase 3 clinical trials were evaluated in a combined IAI-treated group (IAI 2 mg every 4 weeks or 2 mg every 8 weeks after 5 initial monthly doses; n = 475) and a macular laser control group (n = 235) through week 100 in eyes without PDR at baseline (Diabetic Retinopathy Severity Scale [DRSS] score ≤ 53). Improvement in the DRSS score to 35 or better was evaluated in those with a baseline DRSS score of 43 or greater.
A lower proportion of eyes in the IAI group than in the laser group developed a PDR event through week 100 (4.4% vs 11.1%; adjusted difference, -6.7%; 97.5% CI, -11.7 to -1.6; nominal = .0008). All PDR events occurred in eyes with a baseline DRSS score of 43, 47, or 53 and not in those with a score of 35 or less. A greater proportion of eyes in the IAI group than in the control group achieved a DRSS score of 35 or less (20.0% vs 3.8%; nominal < .0001).
Fewer eyes with NPDR and DME treated with IAI than eyes treated with a laser had a PDR event. More eyes treated with IAI improved to mild NPDR or better (DRSS score ≤ 35) through 100 weeks.
本研究旨在评估玻璃体内注射阿柏西普（IAI）或激光治疗（对照）糖尿病性黄斑水肿（DME）后增殖性糖尿病视网膜病变（PDR）事件的发生率以及向轻度非增殖性糖尿病视网膜病变（NPDR）或更好状态的改善情况。
在VISTA（NCT01363440）和VIVID（NCT01331681）这两项3期临床试验中，对联合IAI治疗组（初始每月给药5次后每4周注射2 mg阿柏西普或每8周注射2 mg阿柏西普；n = 475）和黄斑激光对照组（n = 235）中基线时无PDR的眼睛（糖尿病视网膜病变严重程度量表[DRSS]评分≤53）进行至第100周的评估。对基线DRSS评分为43或更高的患者，评估DRSS评分改善至35或更好的情况。
至第100周，IAI组发生PDR事件的眼睛比例低于激光组（4.4%对11.1%；校正差异，-6.7%；97.5%CI，-11.7至-1.6；P值=0.0008）。所有PDR事件均发生在基线DRSS评分为43、47或53的眼睛中，而DRSS评分为35或更低的眼睛未发生。IAI组达到DRSS评分35或更低的眼睛比例高于对照组（20.0%对3.8%；P值<0.0001）。
与接受激光治疗的眼睛相比，接受IAI治疗的NPDR和DME眼睛发生PDR事件的较少。更多接受IAI治疗的眼睛在100周内改善至轻度NPDR或更好状态（DRSS评分≤35）。
