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VISTA和VIVID研究中患者对侧眼新发糖尿病性黄斑水肿的发生率

INCIDENCE OF NEW DIABETIC MACULAR EDEMA IN FELLOW EYES OF PATIENTS IN THE VISTA AND VIVID STUDIES.

作者信息

Dhoot Dilsher S, Moini Hadi, Reed Kimberly, Silva Fabiana Q, Berliner Alyson, Du Weiming, Sharma Sumit

机构信息

California Retina Consultants/Retina Consultants of America, Santa Barbara, California.

Regeneron Pharmaceuticals, Inc., Tarrytown, New York; and.

出版信息

Retina. 2023 Feb 1;43(2):254-262. doi: 10.1097/IAE.0000000000003658. Epub 2022 Oct 17.

Abstract

PURPOSE

To characterize diabetic macular edema (DME) incidence in fellow eyes of patients treated for DME in the study eye.

METHODS

This post hoc analysis of VISTA/VIVID data evaluated fellow eyes without DME at baseline through Week 100. Diabetic macular edema presence in the fellow eye was inferred by investigator-reported DME adverse events and use of DME treatments.

RESULTS

Over 100 weeks, 44.9%, 44.2%, and 42.9% of fellow eyes developed DME in the intravitreal aflibercept injection 2 mg every 4 weeks (n = 245), intravitreal aflibercept injection 2 mg every 8 weeks (n = 258), and laser control (n = 252) groups, respectively. Mean time to DME development in combined treatment groups was ∼6 months. Multivariable regression analysis confirmed patients with shorter diabetes duration (hazard ratio per 10-year decrease, 1.16; 95% confidence interval, 1.03-1.30; P = 0.0160) and thicker baseline study eye central subfield thickness (hazard ratio per 10- µ m increase, 1.01; 95% confidence interval, 1.01-1.02; P = 0.0002) were at higher risk of developing DME in the fellow eye.

CONCLUSION

Among patients with DME in one eye at baseline, almost half developed DME in the fellow eye over 2 years. Shorter duration of diabetes and thicker study eye central subfield thickness were predictors of DME development in the fellow eye.

摘要

目的

对在研究眼中接受糖尿病性黄斑水肿(DME)治疗的患者的对侧眼DME发病率进行特征描述。

方法

这项对VISTA/VIVID数据的事后分析评估了基线至第100周时无DME的对侧眼。通过研究者报告的DME不良事件和DME治疗的使用情况推断对侧眼中是否存在DME。

结果

在100周内,每4周注射2mg玻璃体内阿柏西普组(n = 245)、每8周注射2mg玻璃体内阿柏西普组(n = 258)和激光对照组(n = 252)中,分别有44.9%、44.2%和42.9%的对侧眼发生了DME。联合治疗组中DME发生的平均时间约为6个月。多变量回归分析证实,糖尿病病程较短(每减少10年的风险比,1.16;95%置信区间,1.03 - 1.30;P = 0.0160)以及研究眼基线中心子场厚度较厚(每增加10μm的风险比,1.01;95%置信区间,1.01 - 1.02;P = 0.0002)的患者,对侧眼发生DME的风险更高。

结论

在基线时一只眼患有DME的患者中,近一半在2年内对侧眼发生了DME。糖尿病病程较短和研究眼中心子场厚度较厚是对侧眼发生DME的预测因素。

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