EUCTR2018-004042-42-ES进行中（未招募）1 期
A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-MASKED, ACTIVE COMPARATOR-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FARICIMAB IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION (LUCERNE) - LUCERNE
Roche Farma S.A.(Soc. Unipersonal)que realiza el ensayo en España y que actua como representante F.Hoffmann-La Roche LTD0 个研究点目标入组 658 人开始时间: 2019年4月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 658
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Age >= 50 years
- •- Ability to comply with the study protocol
- •- For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods during the treatment period and for at least 3 months after the final dose of study treatment
- •- Treatment-naïve choroidal neovascularization (CNV) secondary to AMD (nAMD) in the study eye
- •- BCVA of 20/32 to 20/320 (letter score of 78 to 24) in the study eye at the initiation of treatment
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 165
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 475
排除标准
- •- Uncontrolled blood pressure
- •- Pregnancy or breastfeeding, or intention to become pregnant during the study
- •- CNV due to causes other than AMD in the study eye
- •- Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid in the study eye
- •- Presence at screening of central serous chorioretinopathy in the study eye
- •- Retinal pigment epithelial tear involving the macula on Day 1 in the study eye
- •- On FFA/ Color fundus photograph:
- •o Subretinal hemorrhage of > 50% of the total lesion area and/or that involves the fovea
- •o Fibrosis or atrophy of > 50% of the total lesion area and/or that involves the fovea
- •- Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the study
- •- Current vitreous hemorrhage on Day 1 in the study eye
- •- Uncontrolled glaucoma in the study eye
- •- Spherical equivalent of refractive error demonstrating more than 8 diopters of myopia in the study eye
- •- Any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities in the study eye
- •- Any cataract surgery or treatment for complications of cataract surgery with steroids or YAG laser capsulotomy in the study eye within 3 months prior to Day 1
- •- Any other intraocular surgery in the study eye
- •- Prior periocular pharmacological or IVT treatment for other retinal diseases in the study eye
- •- Prior IVT administration of faricimab in either eye
- •- Active ocular inflammation or suspected or active ocular or periocular infection in either eye
研究者
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