MERLIN: Two-Year Results of Brolucizumab in Participants with Neovascular Age-Related Macular Degeneration and Persistent Retinal Fluid.

IF 13.1 1区 医学 Q1 OPHTHALMOLOGY Ophthalmology Pub Date : 2024-09-07 DOI:10.1016/j.ophtha.2024.08.022
David M Brown, Glenn J Jaffe, Charles C Wykoff, Eser Adiguzel, Jeffrey S Heier, Arshad M Khanani
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Abstract

Purpose: To report the safety and efficacy of brolucizumab (Beovu) 6 mg versus aflibercept (Eylea) 2 mg administered every 4 weeks in participants with neovascular age-related macular degeneration (nAMD) and persistent retinal fluid after the week 52 up to week 104.

Design: Multicenter, randomized, double-masked phase 3a study.

Participants: Participants with recalcitrant nAMD (persistent residual retinal fluid despite previous frequent anti-VEGF treatment).

Methods: Study eyes were randomized 2:1 to intravitreal brolucizumab 6 mg or aflibercept 2 mg every 4 weeks for 100 weeks or until study termination.

Main outcome measures: All available efficacy (analysis of noninferiority in mean best-corrected visual acuity [BCVA], central subfield thickness [CST], fluid-free status [no intraretinal fluid and no subretinal fluid]) and safety data up to study termination, including data up to week 104 for those participants who completed the study before its termination. All P values after week 52 were nominal and reflect observed data for the efficacy analyses.

Results: Brolucizumab 6 mg every 4 weeks was noninferior to aflibercept 2 mg in mean BCVA change from baseline to week 104 (least squares mean difference, -0.4 ETDRS letters; 95% confidence interval [CI], -3.7 to 3.0; P = 0.0169). The proportion of eyes with ≥15-letter loss was 6.2% for brolucizumab and 4.7% for aflibercept (P = 0.7762), and a greater proportion of eyes were fluid free at week 104 (52.5% brolucizumab vs. 28.2% aflibercept; 95% CI, 11.9-37.3; P < 0.001) in eyes treated with brolucizumab versus aflibercept. Incidence of intraocular inflammation (IOI), including retinal vasculitis and retinal vascular occlusion, was 11.5% (0.8% and 2.2%) for brolucizumab versus 6.1% (0% and 0.6%) for aflibercept.

Conclusions: Consistent with 52-week results, brolucizumab 6 mg every 4 weeks was noninferior in mean BCVA change, with anatomic outcomes superior to aflibercept 2 mg every 4 weeks from baseline to week 104 or study termination. The incidence of IOI, including retinal vasculitis and retinal vascular occlusion, was higher with brolucizumab versus aflibercept; therefore, brolucizumab should not be used more frequently than every 8 weeks after the loading regimen.

Financial disclosure(s): Proprietary or commercial disclosure may be found after the references.

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MERLIN:布鲁珠单抗治疗新生血管性老年黄斑变性和持续性视网膜积液患者的两年研究结果。
目的:在第52周主要终点分析后(从第52周到第104周,即研究终止后),报告在患有新生血管性年龄相关性黄斑变性(nAMD)和持续性视网膜积液的参与者中,每4周服用6毫克brolucizumab(倍优®)与2毫克aflibercept(Eylea®)的安全性和有效性:设计:多中心、随机、双掩蔽 3a 期研究:多中心、随机、双掩蔽 3a 期研究。参与者:患有顽固性 nAMD 的参与者(尽管之前频繁接受抗血管内皮生长因子治疗,但视网膜仍持续残留积液):方法:研究眼球按2:1随机分配到玻璃体内brolucizumab 6 mg或aflibercept 2 mg,每4周一次,持续100周或直到研究终止:所有可用的疗效数据(最佳矫正视力[BCVA]、中央子场厚度[CST]、无积液状态[无视网膜内积液和无视网膜下积液]的非劣效性分析)和截至研究终止的安全性数据,包括在研究终止前完成研究的参与者截至第104周的数据。第52周后的所有P值均为名义值,反映的是疗效分析的观察数据:从基线到第104周的平均BCVA变化(最小二乘法平均差,-0.4个早期治疗糖尿病视网膜病变研究字母;95%置信区间[CI],-3.7到3.0;P = 0.0169)来看,每4周一次的6毫克布卢单抗不劣于2毫克阿夫利拜特。brolucizumab和aflibercept的视力损失≥15个字母的眼睛比例分别为6.2%和4.7%(P = 0.0014)。(在第104周时,接受brolucizumab治疗的眼睛与接受aflibercept治疗的眼睛相比,无积液的眼睛比例更高(brolucizumab为52.5%,aflibercept为28.2%;95% CI,11.9-37.3;P < 0.001)。包括视网膜血管炎和视网膜血管闭塞在内的眼内炎症(IOI)发生率,brolucizumab为11.5%(0.8%和2.2%),aflibercept为6.1%(0%和0.6%):与52周的结果一致,从基线到第104周或研究终止,每4周一次、每次6毫克的brolucizumab在BCVA平均变化方面不劣于每4周一次、每次2毫克的aflibercept,解剖结果也优于aflibercept。与aflibercept相比,brolucizumab的IOI(包括视网膜血管炎和视网膜血管闭塞)发生率更高;因此,brolucizumab的使用频率不应超过负荷疗法后的每8周一次。
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来源期刊
Ophthalmology
Ophthalmology 医学-眼科学
CiteScore
22.30
自引率
3.60%
发文量
412
审稿时长
18 days
期刊介绍: The journal Ophthalmology, from the American Academy of Ophthalmology, contributes to society by publishing research in clinical and basic science related to vision.It upholds excellence through unbiased peer-review, fostering innovation, promoting discovery, and encouraging lifelong learning.
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