EUCTR2016-000423-13-PL进行中（未招募）1 期
A MULTICENTER, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETYAND TOLERABILITY OF LAMPALIZUMAB IN PATIENTS WITH GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION WHO HAVE COMPLETED AROCHE-SPONSORED STUDY - Omaspect
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,800
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
- •- Previous enrollment in Studies GX29176 (NCT02247479) or GX29185 (NCT02247531) with completion of both treatment and the Week 96 visit
- •- Agreement to remain abstinent or use a reliable form of contraception among all men and women of child-bearing potential
- •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 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1710
排除标准
- •- Concurrent ocular conditions that contraindicate use of lampalizumab or might affect interpretation of study results or that might increase the risk of treatment complications
- •- Concurrent disease, metabolic dysfunction, or physical or laboratory finding that contraindicates use of lampalizumab or might affect interpretation of study results or that might increase the risk of treatment complications
- •- Predisposition to or history of increased risk of infection
- •- Pregnancy or lactation
研究者
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