JPRN-jRCT2031220231进行中（未招募）4 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
itin Jain, M.D.0 个研究点目标入组 132 人开始时间: 2022年7月30日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 132
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
- 年龄范围
- >= 50age old 至 ot applicable（—）
- 性别
- All
入选标准
- •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 on study Day 1
- •For female participants of childbearing potential: agreement to remain abstinent or use contraceptive methods with a failure rate of < 1% per year, during the treatment period and for 38 days after the final dose of faricimab
排除标准
- •Any major illness or major surgical procedure within 1 month before screening
- •Continuous use of any medications and treatments indicated in Prohibited Therapy
- •Uncontrolled blood pressure on study Day 1
- •History of stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to study Day 1
- •History of other disease, metabolic dysfunction, physical examination finding, or historical or current clinical laboratory findings giving reasonable suspicion of a condition that contraindicates the use of the investigational drug or that might affect interpretation of the results of the study or renders the participant at high risk for treatment complications in the opinion of the investigator
- •History of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the faricimab injection, study-related procedure preparations (including fluorescein and indocyanine green dyes), dilating drops, or any of the anesthetic and antimicrobial preparations used by a participant during the study
- •Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 38 days after the final dose of faricimab
- •Spherical equivalent of refractive error demonstrating more than 8 diopters of myopia (For participants who have undergone prior refractive or cataract surgery, the preoperative refractive error should not have exceeded -8 diopters of myopia.)
- •Any cataract surgery or treatment for complications of cataract surgery with steroids or yttrium-aluminum-garnet (YAG) laser capsulotomy within 3 months prior to study Day 1
- •Prior periocular pharmacological or IVT treatment (including anti-VEGF medication) for other retinal diseases
- •Any prior or concomitant treatment for PCV or other retinal diseases, including, but not restricted to, IVT treatment (e.g., faricimab, anti-VEGF, steroids, tissue plasminogen activator, ocriplasmin, C3F8, air), periocular pharmacological intervention, argon laser photocoagulation, verteporfin PDT, diode laser, transpupillary thermotherapy, or ocular surgical intervention
- •Uncontrolled glaucoma
研究者
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