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新生血管性年龄相关性黄斑变性中视力与玻璃体腔注射阿柏西普治疗并延长给药方案的液体积聚之间的关联:一项ARIES事后分析

Association Between Visual Acuity and Fluid Compartments with Treat-and-Extend Intravitreal Aflibercept in Neovascular Age-Related Macular Degeneration: An ARIES Post Hoc Analysis.

作者信息

Chaudhary Varun, Holz Frank G, Wolf Sebastian, Midena Edoardo, Souied Eric H, Allmeier Helmut, Lambrou George, Machewitz Tobias, Mitchell Paul

机构信息

Hamilton Regional Eye Institute, St Joseph's Healthcare, Hamilton and Hamilton Health Sciences, 2757 King Street East Room 2500, Hamilton, ON, L8G 5E4, Canada.

Division of Ophthalmology, Department of Surgery, McMaster University, Hamilton, ON, Canada.

出版信息

Ophthalmol Ther. 2022 Jun;11(3):1119-1130. doi: 10.1007/s40123-022-00491-1. Epub 2022 Mar 18.

Abstract

INTRODUCTION

Recently, there has been growing interest in exploring the relationship between visual acuity and fluid localization in different retinal compartments. This post hoc analysis of the ARIES study explores the relationship between the presence of intraretinal fluid (IRF) and subretinal fluid (SRF), both at baseline and throughout treatment, and best-corrected visual acuity (BCVA) in patients with neovascular age-related macular degeneration (nAMD) treated with intravitreal aflibercept (IVT-AFL) in a treat-and-extend regimen.

METHODS

ARIES (NCT02581891) was a multicenter, randomized, phase 3b/4 study comparing the efficacy of two IVT-AFL treat-and-extend regimens over 2 years in patients with treatment-naïve nAMD. This post hoc analysis explores the relationship between the presence of SRF/IRF and absolute BCVA (letter score) at baseline and fixed visits.

RESULTS

In 210 patients (treat-and-extend treatment arms combined), SRF presence at baseline was associated at every time point with a numerically higher mean BCVA than if absent, with 10 more letters at week 104. IRF presence at baseline was associated at all but one time point with a numerically lower mean BCVA than if absent (week 104, 8-letter difference). Baseline SRF+IRF was associated with lower BCVA (week 104, 7-letter difference) than if only SRF was present, but higher BCVA (week 104, 8-letter difference) than if only IRF was present. Absence of SRF+IRF was not associated with better BCVA at any time point during the study.

CONCLUSION

In ARIES, in patients with nAMD treated with IVT-AFL, the presence of SRF was associated with better visual acuity, whereas IRF was associated with poorer visual acuity. The findings of this post hoc analysis suggest that differentiating IRF from SRF may offer better prognostic value in guiding treatment-extension decisions than the use of combined or "any" IRF and SRF. Prospective trials are needed to validate these results and determine their clinical relevance. TRIAL REGISTRATION NUMBER (CLINICALTRIALS.GOV): NCT02581891. Association between Visual Acuity and Fluid Compartments with Treat-and-Extend Intravitreal Aflibercept in Neovascular Age-Related Macular Degeneration: An ARIES Post Hoc Analysis: A Video Abstract (MP4 308264 KB).

摘要

引言

最近,人们对探索不同视网膜区域的视力与液体定位之间的关系越来越感兴趣。这项对ARIES研究的事后分析探讨了新生血管性年龄相关性黄斑变性(nAMD)患者在基线期及整个治疗过程中视网膜内液(IRF)和视网膜下液(SRF)的存在与最佳矫正视力(BCVA)之间的关系,这些患者接受了玻璃体腔内注射阿柏西普(IVT-AFL)的治疗并延长治疗方案。

方法

ARIES(NCT02581891)是一项多中心、随机、3b/4期研究,比较了两种IVT-AFL治疗并延长治疗方案在初治nAMD患者中2年的疗效。这项事后分析探讨了SRF/IRF的存在与基线期及固定随访时绝对BCVA(字母评分)之间的关系。

结果

在210例患者(治疗并延长治疗组合并)中,基线期存在SRF在每个时间点的平均BCVA数值上均高于不存在SRF的情况,在第104周时高10个字母。基线期存在IRF在除一个时间点外的所有时间点的平均BCVA数值上均低于不存在IRF的情况(第104周,相差8个字母)。基线期SRF+IRF与BCVA较低相关(第104周,相差7个字母),低于仅存在SRF的情况,但高于仅存在IRF的情况(第104周,相差8个字母)。在研究期间的任何时间点,不存在SRF+IRF与更好的BCVA均无关联。

结论

在ARIES研究中,接受IVT-AFL治疗的nAMD患者中,SRF的存在与更好的视力相关,而IRF与较差的视力相关。这项事后分析的结果表明,将IRF与SRF区分开来在指导治疗延长决策方面可能比使用合并的或“任何”IRF和SRF具有更好的预后价值。需要进行前瞻性试验来验证这些结果并确定其临床相关性。试验注册号(CLINICALTRIALS.GOV):NCT02581891。新生血管性年龄相关性黄斑变性中视力与液体区域以及治疗并延长玻璃体腔内注射阿柏西普之间的关联:一项ARIES事后分析:视频摘要(MP4 308264 KB)

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/056f/9114257/881600c89c96/40123_2022_491_Fig1_HTML.jpg

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