视网膜分支静脉闭塞的黄斑水肿复发——阿非利塞普和雷尼单抗在一项随机试验中的比较

IF 4.4 Q1 OPHTHALMOLOGY
Anna Cullhed Farrell, Manuel Casselholm de Salles, Charlotte Lindberg, David Epstein
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引用次数: 0

摘要

目的:前瞻性研究视网膜分支静脉闭塞(BRVO)患者经玻璃体腔注射阿非利塞普或雷尼单抗治疗后黄斑水肿(ME)的复发时间,以及发病时中央凹下脉络膜厚度(SFCT)与水肿复发时间的相关性。设计:随机、双盲、对照临床试验。参与者:2018-2021年间在瑞典斯德哥尔摩圣埃里克眼科医院就诊的110例treatment-naïve BRVO和ME患者。方法:符合条件的患者被随机分为两组,分别接受2 mg (Eylea) (n=55)或0.5 mg (Lucentis) (n=55)的玻璃体内注射。采用光学相干断层扫描(OCT)评估ME和SFCT。计算研究眼与健康眼的SFCT平均差值(diffsct)。每月至少注射三次,直至水肿完全消退。术后观察患者水肿复发情况。随访时间9个月。主要观察指标:初始水肿消退后ME复发的时间,水肿消退所需的注射次数,基线时SFCT与水肿复发时间的相关性。结果:阿非利西普组ME的平均复发时间明显更长,平均时间为10.7±2.9周,而雷尼单抗组为8.9±1.5周(结论:阿非利西普组BRVO ME的复发时间明显长于雷尼单抗组。基线时较高的SFCT和较困难的SFCT与较短的水肿复发时间相关,表明这些参数可以作为BRVO的预测OCT生物标志物。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Recurrence of Macular Edema in Branch Retinal Vein Occlusion - a Comparison of Aflibercept and Ranibizumab in a Randomized Trial.

Objective: To prospectively investigate the time to recurrence of macular edema (ME) in patients with branch retinal vein occlusion (BRVO) treated with intravitreal aflibercept or intravitreal ranibizumab injections, and the correlation between subfoveal choroidal thickness (SFCT) at disease onset and the time to edema recurrence.

Design: Randomized, double-masked, controlled clinical trial.

Participants: One hundred and ten patients with treatment-naïve BRVO and ME presenting between 2018-2021 at St. Erik Eye Hospital, Stockholm, Sweden.

Methods: Eligible patients were randomized to receive intravitreal injections with aflibercept 2 mg (Eylea) (n=55) or ranibizumab 0.5 mg (Lucentis) (n=55). ME and SFCT were assessed with optical coherence tomography (OCT). The mean difference in SFCT (diffSFCT) between the study eyes and healthy fellow eyes was calculated. A minimum of three injections were administered monthly until complete resolution of the edema. Thereafter the patients were monitored for edema recurrence. Total follow-up time was 9 months.

Main outcome measures: Time to recurrence of ME after the initial edema resolution, number of injections required for the edema to resolve, and the correlation between SFCT at baseline and time to edema recurrence.

Results: Mean time to recurrence of ME was significantly longer in the aflibercept group, with a mean time of 10.7±2.9 weeks compared to 8.9±1.5 weeks in the ranibizumab group (p<0.001). There was no difference between the groups regarding the number of monthly injections required to obtain edema resolution, with a mean number of 2.1 injections in each group. Overall, a greater SFCT and diffSFCT at baseline was associated with a shorter time to edema recurrence. When analyzing the diffSFCT by quartiles, the mean time to recurrence was 9.2±1.6 weeks in the top quartile (diffSFCT ≥99 μm) compared to 11.2±3.0 weeks in the bottom quartile (diffSFCT ≤10 μm) (p=0.017).

Conclusions: Time to recurrence of ME in BRVO was significantly longer in patients treated with aflibercept compared to those receiving ranibizumab. A greater SFCT and diffSFCT at baseline was associated with a shorter time to edema recurrence, suggesting that these parameters could serve as predictive OCT biomarkers in BRVO.

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来源期刊
Ophthalmology. Retina
Ophthalmology. Retina Medicine-Ophthalmology
CiteScore
7.80
自引率
6.70%
发文量
274
审稿时长
33 days
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