EUCTR2012-000578-41-DE进行中（未招募）1 期
A MULTICENTER, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND TOLERABILITY OF LAMPALIZUMAB (FCFD4514S) IN PATIENTS WITH GEOGRAPHIC ATROPHY WHO HAVE COMPLETED GENENTECH-SPONSORED LAMPALIZUMAB STUDIES - N.A.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
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
- •For CFD4870g patients: Previous enrollment and completion (Month 18 visit) of Study CFD4870g without early treatment discontinuation (Lampalizumab or sham)
- •- For GX29455 patients: Previous enrollment and completion (Week 24 visit) of Study GX29455 without early treatment discontinuation (lampalizumab or sham)
- •- Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit quality fundus imaging
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 215
排除标准
- •Early treatment and/or study discontinuation prior to completion of
- •study CFD4870g (GX01456) or study GX29455
- •History of vitrectomy surgery, submacular surgery, or other surgical
- •intervention for AMD in the study eye
- •Previous subfoveal focal laser photocoagulation in the study eye
- •Previous treatment with Visudyne, external-beam radiation therapy, or
- •transpupillary thermotherapy in the study eye
- •Previous intravitreal drug delivery (e.g., ITV corticosteroid injection,
- •antiangiogenic drugs, anti-complement drugs, or device implantation) in
- •the study eye. Lampalizumab in study eye and ranibizumab in either eye are permitted.
研究者
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