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临床试验/EUCTR2016-000423-13-DK
EUCTR2016-000423-13-DK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

F. Hoffmann-La Roche Ltd0 个研究点目标入组 1,800 人开始时间: 2016年8月22日最近更新:

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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