IMPACT OF FARICIMAB VERSUS AFLIBERCEPT ON EPIRETINAL MEMBRANE FORMATION OVER 2 YEARS IN PATIENTS WITH DIABETIC MACULAR EDEMA IN THE PHASE 3 YOSEMITE AND RHINE TRIALS.

IF 2.1 2区医学 Q2 OPHTHALMOLOGY

Retina-The Journal of Retinal and Vitreous Diseases Pub Date : 2025-07-14 DOI:10.1097/IAE.0000000000004572

Glenn J Jaffe, Gábor Deák, Kara Gibson, Rahul N Khurana, Eric Nudleman, Yuichiro Ogura, Ursula Schmidt-Erfurth, Tracey Wang, Peter D Westenskow, David Wong, Glenn Yiu, Jeffrey R Willis

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Abstract

Purpose: To assess the effects of faricimab versus aflibercept on epiretinal membrane (ERM) formation in eyes with diabetic macular edema (DME).

Methods: Post hoc analysis of phase 3 YOSEMITE/RHINE trial data in eyes with DME receiving faricimab Q8W, faricimab treat-and-extend (T&E; up to Q16W depending on central subfield thickness [CST] and best-corrected visual acuity [BCVA]), or aflibercept Q8W for 100 weeks.

Results: ERMs developed in 3.8% (23/602) of eyes treated with faricimab Q8W, 5.1% (31/608) with faricimab T&E, and 7.6% (45/590) with aflibercept Q8W at 100 weeks. ERMs were less likely with faricimab Q8W versus aflibercept Q8W (odds ratio [OR] 0.48, 95% confidence interval [CI] 0.29-0.81, P = 0.0055). Mean (SD) BCVA at 100 weeks in eyes with and without ERMs were 69.2 (13.6) letters [20/40 Snellen] versus 73.8 (13.1) [20/40 Snellen], respectively; mean (SD) CSTs were 315.8 (99.2) vs. 274.6 (74.1) µm. Faricimab T&E dosing intervals were extended ≥ Q12W in 79.7% of eyes without ERMs versus 50.0% with ERMs.

Conclusion: Risk of ERMs was 52% lower with faricimab Q8W versus aflibercept Q8W over 100 weeks in eyes with DME, suggesting a potential role for faricimab in reducing pre-retinal fibrotic proliferation. Results may help inform physician/patient decision-making when initiating intravitreal therapy.

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在约塞米蒂和莱茵的3期临床试验中，法利昔单抗与阿非利塞普对糖尿病性黄斑水肿患者2年内视网膜前膜形成的影响

目的：评价法利西单抗与阿非利西普对糖尿病性黄斑水肿（DME）视网膜前膜（ERM）形成的影响。方法：对接受faricimab Q8W、faricimab治疗和延长(T&E；根据中心子野厚度[CST]和最佳矫正视力[BCVA]，最高可达Q16W，或afliberept Q8W，持续100周。结果：100周时，faricimab Q8W组有3.8%（23/602）的眼睛出现erm， faricimab T&E组有5.1% (31/608)，afliberept Q8W组有7.6%（45/590）。法利昔单抗Q8W与阿非利西ept Q8W相比，发生erm的可能性更小（优势比[OR] 0.48, 95%可信区间[CI] 0.29-0.81, P = 0.0055）。在有和没有erm的眼睛中，100周时的平均（SD） BCVA分别为69.2（13.6）个字母[20/40 Snellen]和73.8（13.1）个字母[20/40 Snellen]；平均（SD） cst分别为315.8（99.2）和274.6（74.1）µm。Faricimab T&E给药间隔在无erm的79.7%和有erm的50.0%的眼睛中延长≥Q12W。结论：法利西单抗Q8W在DME患者100周内发生erm的风险比阿非利赛普Q8W低52%，表明法利西单抗在减少视网膜前纤维化增殖方面具有潜在作用。结果可能有助于医生/患者决定何时开始玻璃体内治疗。

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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来源期刊

Retina-The Journal of Retinal and Vitreous Diseases 医学-眼科学

CiteScore

5.70

自引率

9.10%

发文量

554

审稿时长

3-6 weeks

期刊介绍： RETINA® focuses exclusively on the growing specialty of vitreoretinal disorders. The Journal provides current information on diagnostic and therapeutic techniques. Its highly specialized and informative, peer-reviewed articles are easily applicable to clinical practice. In addition to regular reports from clinical and basic science investigators, RETINA® publishes special features including periodic review articles on pertinent topics, special articles dealing with surgical and other therapeutic techniques, and abstract cards. Issues are abundantly illustrated in vivid full color. Published 12 times per year, RETINA® is truly a “must have” publication for anyone connected to this field.