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Archway Randomized Phase 3 Trial of the Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration.[研究名称] 研究:采用雷珠单抗的输送系统治疗新生血管性年龄相关性黄斑变性的随机 3 期临床试验。
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Ophthalmologica. 2021;244(2):93-101. doi: 10.1159/000513048. Epub 2020 Nov 16.
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Efficacy of a Treat-and-Extend Regimen With Ranibizumab in Patients With Neovascular Age-Related Macular Disease: A Randomized Clinical Trial.雷珠单抗治疗新生血管性年龄相关性黄斑变性的疗效:一项随机临床试验。
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Eye (Lond). 2020 Oct;34(10):1825-1834. doi: 10.1038/s41433-019-0747-x. Epub 2020 Jan 3.
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Polypoidal choroidal vasculopathy in Canada.加拿大的息肉样脉络膜血管病变。
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抗血管内皮生长因子药物玻璃体腔内注射治疗新生血管性年龄相关性黄斑变性的按需治疗策略:一项荟萃分析。

Treat-and-extend dosing of intravitreal anti-VEGF agents in neovascular age-related macular degeneration: a meta-analysis.

机构信息

Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, ON, Canada.

Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada.

出版信息

Eye (Lond). 2023 Oct;37(14):2855-2863. doi: 10.1038/s41433-023-02439-6. Epub 2023 Mar 1.

DOI:10.1038/s41433-023-02439-6
PMID:36859600
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10517126/
Abstract

Intravitreal injections of antiangiogenic agents are pivotal in treating neovascular age-related macular degeneration (nAMD). The comparative efficacy and safety of treat-and-extend (T&E) versus bimonthly, monthly, and pro re nata (PRN) dosing remains unclear. A systematic review and meta-analysis of English-language RCTs reporting on efficacy and/or safety outcomes of dosing regimens of anti-VEGF agents in nAMD was performed. Best-corrected visual acuity (BCVA, ETDRS letters) at last follow-up represented the primary endpoint, while central subfield thickness (CSFT, μm), injection burden, and ocular adverse events were secondary endpoints. A random effects meta-analysis was performed, and 95% confidence intervals were calculated. Across six RCTs, 781 T&E-, 663 monthly-, 130 PRN-, and 123 bimonthly treated eyes were included. Mean changes in BCVA and CSFT at last follow-up were similar between T&E versus monthly (WMD, -0.62 letters; 95% CI, -2.12 to 0.87; P = 0.41; WMD, 5.30 microns; 95% CI, -10.67 to 21.26; P = 0.52, respectively), bimonthly (WMD, 1.68 letters; 95% CI, -3.55 to 6.91; P = 0.53; WMD, -18.91 microns; 95% CI, -46.41 to 8.60; P = 0.18, respectively), and PRN (BCVA WMD, 1.08 letters; 95% CI, -2.95 to 5.11; P = 0.60) regimens. T&E was associated with a reduced injection burden versus monthly (WMD, -4.52 injections; 95% CI, -6.66 to 2.39; P < 0.001) but higher injection burden versus PRN (WMD, 1.81 injections; 95% CI, 1.12 to 2.51; P < 0.001) dosing. There was no significant difference in safety outcomes amongst comparators. There was no significant difference in efficacy and safety between T&E, bimonthly, monthly, and PRN dosing. T&E resulted in fewer injections versus monthly and fewer clinic visits versus PRN.

摘要

玻璃体内注射抗血管生成药物是治疗新生血管性年龄相关性黄斑变性(nAMD)的关键。关于抗 VEGF 药物剂量方案的治疗和扩展(T&E)与双月、每月和按需(PRN)治疗的疗效和安全性仍不清楚。对报告抗 VEGF 药物剂量方案疗效和/或安全性结果的英文随机对照试验进行了系统评价和荟萃分析。最后一次随访时的最佳矫正视力(BCVA,ETDRS 字母)为主要终点,而中心凹下视网膜厚度(CSFT,μm)、注射负担和眼部不良事件为次要终点。进行了随机效应荟萃分析,并计算了 95%置信区间。在六项 RCT 中,纳入了 781 只 T&E 治疗眼、663 只每月治疗眼、130 只 PRN 治疗眼和 123 只双月治疗眼。最后一次随访时 BCVA 和 CSFT 的平均变化在 T&E 与每月(WMD,-0.62 个字母;95%CI,-2.12 至 0.87;P=0.41;WMD,5.30μm;95%CI,-10.67 至 21.26;P=0.52)、双月(WMD,1.68 个字母;95%CI,-3.55 至 6.91;P=0.53;WMD,-18.91μm;95%CI,-46.41 至 8.60;P=0.18)和 PRN(BCVA WMD,1.08 个字母;95%CI,-2.95 至 5.11;P=0.60)方案之间相似。与每月相比,T&E 方案的注射负担较低(WMD,-4.52 次注射;95%CI,-6.66 至 2.39;P<0.001),但与 PRN 相比,注射负担较高(WMD,1.81 次注射;95%CI,1.12 至 2.51;P<0.001)。在比较组之间,安全性结果没有显著差异。T&E、双月、每月和 PRN 剂量方案在疗效和安全性方面没有显著差异。与每月相比,T&E 方案的注射次数更少,与 PRN 相比,就诊次数更少。