EUCTR2020-003987-22-NL招募中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. - ORACLE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 200
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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 180
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
相似试验
进行中（未招募）
1 期
Study to evaluate the long term safety of GT005 in participants having macular degeneration that led to geographic atrophy in their eyes and that have been previously treated in a prior Gyroscope study using the same product.Geographic atrophy (GA) secondary to age-related macular degeneration (AMD) in participants already treated with GT005 in the GT005-02 (EXPLORE) and GT005-03 (HORIZON) antecedent studies.MedDRA version: 20.0Level: LLTClassification code 10075719Term: Atrophic age-related macular degenerationSystem Organ Class: 100000004853EUCTR2020-003987-22-ESGyroscope Therapeutics Ltd.200
撤回
2 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.NL-OMON56154Gyroscope Therapeutics Ltd.15
进行中（未招募）
1 期
Study to evaluate the long term safety of GT005 in participants having macular degeneration that led to geographic atrophy in their eyes and that have been previously treated in a prior Gyroscope study using the same product.Geographic atrophy (GA) secondary to age-related macular degeneration (AMD) in participants already treated with GT005 in the GT005-02 (EXPLORE) and GT005-03 (HORIZON) antecedent studies.MedDRA version: 20.0Level: LLTClassification code 10075719Term: Atrophic age-related macular degenerationSystem Organ Class: 100000004853EUCTR2020-003987-22-IEGyroscope Therapeutics Ltd.300
进行中（未招募）
1 期
Study to evaluate the long-term safety of GT005 in participants having macular degeneration that led to geographic atrophy in their eyes and that have been previously treated in a prior Gyroscope study using the same product.Geographic atrophy (GA) secondary to age-related macular degeneration (AMD) in participants already treated with GT005 in the previous studies GT005-01 (FOCUS), GT005-02 (EXPLORE) and GT005-03 (HORIZON).MedDRA version: 20.0Level: LLTClassification code: 10075719Term: Atrophic age-related macular degeneration Class: 10015919CTIS2024-510946-15-00Gyroscope Therapeutics Limited163
进行中（未招募）
1 期
Study to evaluate the long term safety of GT005 in participants having macular degeneration that led to geographic atrophy in their eyes and that have been previously treated in a prior Gyroscope study using the same product.Geographic atrophy (GA) secondary to age-related macular degeneration (AMD) in participants already treated with GT005 in the GT-005-1 (FOCUS), GT-005-02 (EXPLORE) and GT005-03 (HORIZON) antecedent studies.MedDRA version: 20.0Level: LLTClassification code 10075719Term: Atrophic age-related macular degenerationSystem Organ Class: 10015919 - Eye disordersEUCTR2020-003987-22-DEGyroscope Therapeutics Ltd.225