CTRI/2023/03/050939已完成3 期
A Phase IIIb/IV, Multicenter, Open-Label, Single-Arm Study To Investigate The Efficacy And Safety Of Faricimab (RO6867461) In Patients With Polypoidal Choroidal Vasculopathy - SALWEE
F HoffmannLa Roche Ltd0 个研究点目标入组 3 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Participants who are able to comply with the study protocol, in the investigator’s judgment.
- •For female participants of childbearing potential: agreement to remain abstinent or use contraception.
- •Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis.
- •Confirmed diagnosis, by the investigator, of symptomatic macular PCV.
- •BCVA scores of 78?24 ETDRS letters, inclusive (20/32 to 20/320 approximate
- •Snellen equivalent), using the ETDRS protocol and assessed at the initial testing distance of 4 meters (see the BCVA manual for additional details) on study Day 1
排除标准
- •Treatment with investigational therapy (device, drug, or traditional medicine with the exception of vitamins and minerals) within 3 months prior to initiation of study treatment on study Day 1.
- •Any major illness or major surgical procedure within 1 month before screening.
- •Active cancer within the 12 months prior to study Day 1 except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer.
- •Systemic treatment for suspected or active systemic infection on study Day 1.
- •Uncontrolled blood pressure, while the participant is at rest on study Day 1.
- •History of stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to study Day 1.
- •Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 28 days after the final dose of faricimab.
- •History of idiopathic or autoimmune-associated uveitis in either eye.
- •Active ocular inflammation or suspected or active ocular or periocular infection in either eye on study Day 1.
- •Any history or presence of macular pathology unrelated to PCV affecting vision or contributing to the presence of macular hemorrhage, IRF, or SRF.
- •Retinal pigment epithelial tear involving the macula on study Day 1.
- •Current vitreous hemorrhage on study Day 1.
- •Uncontrolled glaucoma.
- •Prior periocular pharmacological or IVT treatment (including anti-VEGF medication) for other retinal diseases.
- •Participants who have a non-functioning fellow (non study) eye, defined as either BCVA of hand motion or worse, or no physical presence of non study eye (i.e., monocular), at
- •both the screening and study Day 1 visits will be excluded from study entry.
研究者
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