跳至主要内容
临床试验/EUCTR2020-003987-22-IE
EUCTR2020-003987-22-IE进行中(未招募)1 期

ORACLE: A long-term follow-up study to evaluate the safety and durability of GT005 in participants with geographic atrophy, secondary to age-related macular degeneration treated in a Gyroscope-sponsored antecedent study. - GT-ORACLE

Gyroscope Therapeutics Ltd.0 个研究点目标入组 300 人开始时间: 2022年11月22日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
300

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

性别
All

入选标准

  • 1. Able and willing to give written informed consent
  • 2. Received GT005 in an antecedent study, GT005-02 (EXPLORE, NCT04437368 and GT005-03 (HORIZON, NCT04566445)
  • 3. Willing to attend study visits and complete the study procedures.
  • 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 30
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 270

排除标准

  • Not Applicable. If the participant is not able to attend Week 96 visit (End of Study visit for antecedent study) due to personal or medical reasons, the Sponsor should be consulted, and participant asked to attend the Study Centre at their next available opportunity to complete the Visit 1 for the ORACLE study.

研究者

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