需要强化玻璃体内注射阿柏西普治疗的新生血管性年龄相关性黄斑变性患者：一项阿柏西普治疗新生血管性年龄相关性黄斑变性（ARIES）研究的事后分析
Patients with Neovascular Age-Related Macular Degeneration Requiring Intensive Intravitreal Aflibercept Treatment: An ARIES Post Hoc Analysis.
作者信息
Wolf Sebastian, Holz Frank G, Midena Edoardo, Souied Eric H, Lambrou George, Machewitz Tobias, Allmeier Helmut, Mitchell Paul
机构信息
Reading Centre and Department for Ophthalmology, Inselspital, University Hospital, University of Bern, Freiburgstrasse, 3010, Bern, Switzerland.
Department of Ophthalmology, University of Bonn, Bonn, Germany.
出版信息
Ophthalmol Ther. 2022 Oct;11(5):1793-1803. doi: 10.1007/s40123-022-00541-8. Epub 2022 Jul 12.
INTRODUCTION
The aim of this post hoc analysis of the ARIES study is to explore the requirement for intravitreal aflibercept (IVT-AFL) treatment intervals of < 8 weeks (w) in patients with neovascular age-related macular degeneration (nAMD), and to assess vision and anatomic outcomes in such patients who require more intensive treatment.
METHODS
ARIES was a multicenter, randomized, phase 3b/4 study that investigated the efficacy of two IVT-AFL proactive, individualized, treat-and-extend regimens over 2 years in treatment-naïve patients with nAMD. Patients were determined as injection-intensive if the study investigator identified that a treatment interval of < 8 w was needed and if they had ≥ 1 interval of < 8 w after three initial monthly doses. Treatment intervals could be extended subsequently if extension criteria were met. This is a post hoc analysis of patients enrolled in ARIES and statistical analysis is descriptive.
RESULTS
Of 269 patients in the combined treatment arms, 23.0% (n = 62) were injection-intensive (Year 1: 13.8% [n = 37]; Year 2: 9.3% [n = 25]). Time from IVT-AFL initiation to injection-intensive determination varied (range, 16-100 w; median: 43.2 w). Mean treatment interval was 8.4 w before and 6.1 w after injection-intensive determination. Overall, 59.7% achieved treatment intervals of ≥ 8 w following injection-intensive determination. Vision improvements from baseline to Week 104 were smaller for injection-intensive patients than non-injection-intensive patients (mean [SD] best-corrected visual acuity change: + 2.3 [15.6] vs. + 5.9 [12.3] letters). Anatomic outcomes were similar between injection-intensive and non-injection-intensive patients (central retinal thickness change from baseline to Week 104: - 160 [154] vs. - 167 [136] µm).
CONCLUSIONS
In ARIES, 23% of treatment-naïve patients with nAMD experienced at least one treatment interval of < 8 w. Injection-intensive patients showed improved vision and anatomic outcomes. For most, treatment intervals could be extended to ≥ 8 w following injection-intensive determination.
CLINICALTRIALS
gov Identifier: NCT02581891.
引言
本项对ARIES研究的事后分析旨在探讨新生血管性年龄相关性黄斑变性（nAMD）患者玻璃体内注射阿柏西普（IVT-AFL）治疗间隔<8周（w）的必要性，并评估此类需要更强化治疗的患者的视力和解剖学转归。
方法
ARIES是一项多中心、随机、3b/4期研究，在初治nAMD患者中，对两种IVT-AFL主动、个体化、治疗并延长方案的2年疗效进行了研究。如果研究研究者确定需要<8w的治疗间隔，且在最初每月3次给药后有≥1次<8w的间隔，则患者被确定为注射密集型。如果符合延长标准，治疗间隔随后可以延长。这是对ARIES研究中入组患者的事后分析，统计分析为描述性分析。
结果
在联合治疗组的269例患者中，23.0%（n = 62）为注射密集型（第1年：13.8% [n = 37]；第2年：9.3% [n = 25]）。从开始IVT-AFL到确定为注射密集型的时间各不相同（范围：16 - 100w；中位数：43.2w）。注射密集型确定前的平均治疗间隔为8.4w，确定后为6.1w。总体而言，59.7%的患者在注射密集型确定后实现了≥8w的治疗间隔。与非注射密集型患者相比，注射密集型患者从基线到第104周的视力改善较小（平均[标准差]最佳矫正视力变化：+2.3 [15.6] 对 +5.9 [12.3] 字母）。注射密集型和非注射密集型患者的解剖学转归相似（从基线到第104周的中心视网膜厚度变化：-160 [154] 对 -167 [136] µm）。
结论
在ARIES研究中，23%的初治nAMD患者经历了至少1次<8w的治疗间隔。注射密集型患者的视力和解剖学转归有所改善。对于大多数患者，在注射密集型确定后，治疗间隔可以延长至≥8w。
临床试验
美国国立医学图书馆标识符：NCT02581891。
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