一项比较玻璃体内布卢珠单抗与安慰剂治疗慢性中枢性浆液性脉络膜视网膜病变的随机对照试验方案- BRICS报告#1

IF 1.9 4区 医学 Q2 OPHTHALMOLOGY
Srishti Raksheeth Ramamurthy, Saarang Hansraj, Ritesh Narula, SriniVas R Sadda, Sobha Sivaprasad, Jay K Chhablani, Mudit Tyagi, Nikitha Gurram Reddy, Umesh Chandra Behera, Raja Narayanan
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引用次数: 0

摘要

目的:慢性中枢性浆液性脉络膜视网膜病变(CSCR)的治疗缺乏共识。抗vegf药物在无脉络膜新生血管(CNVM)的慢性CSCR治疗中的作用尚不明确。我们的目的是研究玻璃体内布卢珠单抗治疗慢性CSCR无CNVM持续性黄斑积液的疗效。方法:本研究是一项前瞻性随机、安慰剂对照试验,纳入42例持续视网膜内和/或视网膜下积液的慢性CSCR患者(病程0 ~ 3个月)。患者将按1:1的比例随机接受勃鲁单抗或口服多种维生素。主要终点是1个月和3个月的OCT液体溶解。次要结果测量包括最佳矫正视力、显微视力和nei - vfq25主观问卷。结论:本研究的结果将提供对brolucizumab在无CNVM的慢性CSCR中实现液体溶解的有效性和安全性的理解。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Protocol for a Randomized Controlled Trial Comparing Intravitreal Brolucizumab with Placebo for Chronic Central Serous Chorioretinopathy with Persistent Macular Fluid Without Choroidal Neovascular Membrane - BRICS Report #1.

Purpose: Established consensus is lacking for the management of chronic central serous chorioretinopathy (CSCR). The role of anti-VEGF agents in treating chronic CSCR in the absence of choroidal neovascular membrane (CNVM) is equivocal. We aim to study intravitreal brolucizumab in the treatment of persistent macular fluid in chronic CSCR without CNVM.

Methods: This study is a prospective randomized, placebo-controlled trial to be conducted among 42 patients with chronic CSCR (>3 months duration) with persistent intraretinal and/or subretinal fluid. Patients will be randomized in a 1:1 ratio to receive brolucizumab or oral multivitamins. Primary endpoint will be fluid resolution on OCT at 1 and 3 months. Secondary outcome measures will include the best-corrected visual acuity, microperimetry and NEI-VFQ 25 subjective questionnaire.

Conclusion: The results of this study will provide an understanding of the efficacy and safety of brolucizumab in achieving fluid resolution in chronic CSCR without CNVM.

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来源期刊
Seminars in Ophthalmology
Seminars in Ophthalmology OPHTHALMOLOGY-
CiteScore
3.20
自引率
0.00%
发文量
80
审稿时长
>12 weeks
期刊介绍: Seminars in Ophthalmology offers current, clinically oriented reviews on the diagnosis and treatment of ophthalmic disorders. Each issue focuses on a single topic, with a primary emphasis on appropriate surgical techniques.
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