临床试验和现实世界研究检查法利昔单抗和大剂量阿非利西普湿性年龄相关性黄斑变性和糖尿病性黄斑水肿。

IF 2.6 2区 医学 Q1 OPHTHALMOLOGY Current Opinion in Ophthalmology Pub Date : 2025-05-01 Epub Date: 2025-02-12 DOI:10.1097/ICU.0000000000001129
Meghana Kalavar, Jayanth Sridhar
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引用次数: 0

摘要

综述目的:本综述的目的是总结法利昔单抗和大剂量阿非利西普(8mg)的新临床试验和现实世界证据,这两种最近批准的治疗湿性年龄相关性黄斑变性和糖尿病性黄斑水肿的药物。最近的研究发现:Faricimab,一种靶向血管内皮生长因子(VEGF)和血管生成素-2的双特异性单克隆抗体,以及大剂量的aflibercept在延长治疗间隔的同时保持疗效方面具有显著的潜力。关键的临床试验,如YOSEMITE和RHINE,证实faricimab不劣于标准的抗vegf治疗,具有更强的持久性。实际数据证实了这些结果,表明延长治疗间隔改善了解剖结果,尽管最佳矫正视力(BCVA)的改善仍然存在差异。在具有里程碑意义的临床试验(如PHOTON和PULSAR)中,延长给药间隔,大剂量阿伯西普也同样显示出非劣效性。然而,关于大剂量阿非利西普的综合真实数据仍然有限,需要进一步调查。总结:与标准抗vegf治疗相比,faricimab和大剂量aflibercept均显示出通过延长给药间隔来减轻湿性年龄相关性黄斑变性和糖尿病性黄斑水肿的治疗负担,同时维持或改善临床结果的希望。Faricimab已经在临床试验和实际研究中证明了这一点,而大剂量aflibercept已经在试验中证明了类似的耐久性,但需要额外的实际证据。
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Clinical trials and real-world studies examining faricimab and high-dose aflibercept for wet age-related macular degeneration and diabetic macular edema.

Purpose of review: The goal of this review is to summarize emerging clinical trial and real world evidence for faricimab and high dose aflibercept (8 mg), two recently approved treatments for wet age-related macular degeneration and diabetic macular edema.

Recent findings: Faricimab, a bispecific monoclonal antibody targeting vascular endothelial growth factor (VEGF) and angiopoietin-2, and high-dose aflibercept have demonstrated significant potential for extending treatment intervals while maintaining efficacy. Pivotal clinical trials such as YOSEMITE, and RHINE established faricimab to be noninferior to standard anti-VEGF therapy with superior durability. Real-world data corroborated these results, demonstrating improved anatomic outcomes with extended treatment intervals, though improvements in best corrected visual acuity (BCVA) remains varied. High-dose aflibercept has similarly demonstrated noninferiority in landmark clinical trials such as PHOTON and PULSAR, with extended dosing intervals. However, comprehensive real-world data for high dose aflibercept remains limited and warrants further investigation.

Summary: Both faricimab and high-dose aflibercept show promise in reducing treatment burden for wet age-related macular degeneration and diabetic macular edema through extended dosing intervals while maintaining or improving clinical outcomes compared to standard anti-VEGF therapy. Faricimab has demonstrated this both in clinical trials as well as real-world studies, while high-dose aflibercept has demonstrated similar durability in trials but requires additional real-world evidence.

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来源期刊
CiteScore
6.80
自引率
5.40%
发文量
120
审稿时长
6-12 weeks
期刊介绍: Current Opinion in Ophthalmology is an indispensable resource featuring key up-to-date and important advances in the field from around the world. With renowned guest editors for each section, every bimonthly issue of Current Opinion in Ophthalmology delivers a fresh insight into topics such as glaucoma, refractive surgery and corneal and external disorders. With ten sections in total, the journal provides a convenient and thorough review of the field and will be of interest to researchers, clinicians and other healthcare professionals alike.
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