Treat-and-Extend Versus Pro re nata Regimens of Ranibizumab and Aflibercept in Neovascular Age-Related Macular Degeneration: A Comparative Study from Routine Clinical Practice.

IF 2.6 3区医学 Q2 OPHTHALMOLOGY

Ophthalmology and Therapy Pub Date : 2024-09-01 Epub Date: 2024-07-08 DOI:10.1007/s40123-024-00983-2

Eloi Debourdeau, Helene Beylerian, Vuong Nguyen, Daniel Barthelmes, Mark Gillies, Pierre Henry Gabrielle, Stela Vujosevic, Louise Otoole, Martin Puzo, Catherine Creuzot-Garcher, Benjamin Wolff, Vincent Daien

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引用次数: 0

Abstract

Introduction: Anti-vascular endothelial growth factor (VEGF) is generally given using pro re nata or "treat-and-extend" (T&E) regimens for neovascular age-related macular degeneration (nAMD). Randomized clinical trials have reported that T&E is superior to Pro re nata (PRN), but results from clinical trials may not always be replicated in clinical practice. Real-world data comparing T&E and PRN regimens for nAMD are limited. The objective of this work was to report 24-month outcomes of PRN versus T&E regimens for ranibizumab and aflibercept to treat nAMD in routine clinical practice.

Methods: We conducted a retrospective analysis of data from a prospectively designed observational outcomes registry, the Fight Retinal Blindness! Project (FRB). Treatment-naïve eyes starting nAMD treatment with at least three injections using a T&E or PRN regimen were tracked by using the FRB. The primary outcome was the mean change in visual acuity (VA) measured by the number of letters read on a logarithm of the minimum angle of resolution chart at 2 years versus baseline. The secondary outcome was the number of injections at 2 years.

Results: From January 1, 2015 to January 31, 2019, 3313 eyes from 2948 patients with nAMD were included: 1243 eyes from 1065 patients were classified as PRN and 2070 eyes from 1935 patients started a T&E regimen. At 24 months, patients on the T&E regimen experienced significantly greater mean (95% confidence interval) improvement in VA than those on PRN (+ 4.2 [3.1, 5.2] vs. + 1.3 [0.1, 2.6] letters; p < 0.001), with more injections (14.9 standard deviation(SD) 4.3) vs. 9.8(SD 4.3); p < 0.001).

Conclusions: Eyes treated with a T&E regimen had better VA outcomes from VEGF inhibitors than eyes treated PRN. This large real-world data assessment supports previous data from randomized clinical trials that the T&E regimen delivers better outcomes than PRN.

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雷珠单抗和阿弗利百普治疗新生血管性老年性黄斑变性的 "治疗-延长 "方案与 "临终方案"：常规临床实践比较研究》。

导言：抗血管内皮生长因子（VEGF）治疗新生血管性年龄相关性黄斑变性（nAMD）通常采用 "原位 "或 "治疗-延长"（T&E）方案。随机临床试验报告显示，T&E优于Pro re nata（PRN），但临床试验的结果并不总能在临床实践中得到复制。比较 T&E 和 PRN 方案治疗 nAMD 的真实世界数据非常有限。本研究旨在报告常规临床实践中使用雷尼珠单抗和阿弗利贝赛普治疗 nAMD 的 PRN 与 T&E 方案的 24 个月疗效：方法：我们对前瞻性设计的观察结果登记处--抗击视网膜失明项目（FRB）的数据进行了回顾性分析！项目（FRB）的数据进行了回顾性分析。我们通过 FRB 追踪了开始接受 nAMD 治疗并使用 T&E 或 PRN 方案进行至少三次注射的未接受过治疗的眼睛。主要结果是视力（VA）的平均变化，以 2 年后最小解像角对数图上读取的字母数与基线相比来衡量。次要结果是两年内的注射次数：从2015年1月1日至2019年1月31日，共纳入了2948名nAMD患者的3313只眼睛：1065名患者中的1243只眼睛被归类为PRN，1935名患者中的2070只眼睛开始接受T&E治疗。24 个月后，接受 T&E 方案治疗的患者视力改善的平均值（95% 置信区间）明显高于接受 PRN 方案治疗的患者（+ 4.2 [3.1, 5.2] vs. + 1.3 [0.1, 2.6] 个字母；P 结论：接受 T&E 方案治疗的患者视力改善的平均值（95% 置信区间）明显高于接受 PRN 方案治疗的患者：采用 T&E 方案治疗的患者与接受 PRN 治疗的患者相比，血管内皮生长因子抑制剂的 VA 效果更好。这一大型真实世界数据评估支持了之前的随机临床试验数据，即 T&E 方案比 PRN 方案的疗效更好。

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来源期刊

Ophthalmology and Therapy OPHTHALMOLOGY-

CiteScore

4.20

自引率

3.00%

发文量

157

审稿时长

6 weeks

期刊介绍： Aims and Scope Ophthalmology and Therapy is an international, open access, peer-reviewed (single-blind), and rapid publication journal. The scope of the journal is broad and will consider all scientifically sound research from preclinical, clinical (all phases), observational, real-world, and health outcomes research around the use of ophthalmological therapies, devices, and surgical techniques. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/series, trial protocols and short communications such as commentaries and editorials. Ophthalmology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. Rapid Publication The journal’s publication timelines aim for a rapid peer review of 2 weeks. If an article is accepted it will be published 3–4 weeks from acceptance. The rapid timelines are achieved through the combination of a dedicated in-house editorial team, who manage article workflow, and an extensive Editorial and Advisory Board who assist with peer review. This allows the journal to support the rapid dissemination of research, whilst still providing robust peer review. Combined with the journal’s open access model this allows for the rapid, efficient communication of the latest research and reviews, fostering the advancement of ophthalmic therapies. Open Access All articles published by Ophthalmology and Therapy are open access. 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