Evidence for Whom? A Systematic Review of Eligibility Criteria in RCTs of Anti-VEGF for Neovascular Age-Related Macular Degeneration

AJO International Pub Date : 2025-04-12 DOI:10.1016/j.ajoint.2025.100124

Andreas Arnold-Vangsted , Emil Alexander Rosenørn , Emilie Theresa Sørrig Butler , Rodrigo Anguita , Rita Serrano Anjos , Lasse Jørgensen Cehofski , Vibeke Christensen , Lorenzo Ferro Desideri , Jakob Grauslund , Javad Nouri Hajari , Musa Yasin Kaya , Oliver Niels Klefter , Celine Lee , Line Petersen , Miklos Schneider , Yousif Subhi

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Abstract

Purpose

To summarize the eligibility criteria used in randomized controlled trials (RCT) of intravitreal anti-VEGF treatments for neovascular age-related macular degeneration (AMD).

Design

Systematic review.

Methods

A search of 12 literature databases was conducted on 15 April 2024. RCTs of intravitreal anti-VEGF for the treatment of neovascular AMD in treatment-naïve eyes were identified. Data on the eligibility criteria for visual function, disease definition and stage, ocular comorbidities, systemic comorbidities, demographics, and other factors not included in other categories were extracted.

Results

A total of 49 eligible studies were included in this review, which together included 26,995 eyes of 26,995 patients. We identified a range of eligibility criteria on areas of visual function (minimum 18–50 ETDRS letters; maximum 69–78 ETDRS letters), disease definition and stage (FA only vs. multimodal approach), ocular and systemic comorbidities (most frequent exclusion criteria across studies were any history of the following: intraocular surgery, diabetic retinopathy, panretinal photocoagulation, glaucoma, and myopia), demographics, as well as a miscellaneous category with other topics. Studies employed a set of criteria so stringent that it could be questioned to which extent patients included were generalizable to real-world patients with AMD.

Conclusions

RCTs of anti-VEGF treatments for neovascular AMD employ stringent eligibility criteria, which in consequence may reduce the generalizability of findings to real-world populations.

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谁的证据？抗vegf治疗新生血管性年龄相关性黄斑变性的随机对照试验的合格标准的系统评价

目的总结玻璃体内抗vegf治疗新生血管性年龄相关性黄斑变性（AMD）的随机对照试验（RCT）的入选标准。DesignSystematic审查。方法于2024年4月15日检索12个文献数据库。确定玻璃体内抗vegf治疗treatment-naïve眼部新生血管性AMD的随机对照试验。提取了视力功能、疾病定义和分期、眼部合并症、全身合并症、人口统计学和其他未包括在其他类别中的其他因素的合格标准数据。结果本综述共纳入49项符合条件的研究，共纳入26,995例患者的26,995只眼睛。我们确定了一系列视觉功能区域的资格标准(至少18-50个ETDRS字母；最多69-78个ETDRS字母)，疾病定义和分期（仅FA与多模式方法），眼部和全身合并症（研究中最常见的排除标准是有以下病史：眼内手术，糖尿病视网膜病变，全视网膜光凝，青光眼和近视），人口统计学，以及与其他主题的杂项分类。研究采用了一套非常严格的标准，以至于可以质疑纳入的患者在多大程度上可以推广到现实世界的AMD患者。结论抗vegf治疗新生血管性AMD的随机对照试验采用了严格的资格标准，这可能会降低研究结果在现实世界人群中的普遍性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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AJO International

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