Extension Study to Evaluate the Long-term Outcomes of Subjects Following CLS-AX Administration for Age-related Macular Degeneration in the CLS-AX CLS1002-101 Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 6
- 主要终点
- Number of Participants With Serious Adverse Events (SAEs)
研究概览
简要总结
This is an open-label, non-interventional extension study of up to 12 weeks in duration in subjects completing Cohorts 2, 3, and 4 of the Parent study, CLS1002-101.
详细描述
This is an open-label, non-interventional extension study of up to 12 weeks in duration in subjects completing Cohorts 2. 3 and 4 of the Parent study, CLS1002-101. The Parent study is a 12-week, Phase 1/2a, multicenter study designed to assess the safety and tolerability of a single dose of CLS-AX administered suprachoroidally in subjects with neovascular age-related macular degeneration (nAMD) who show stable visual acuity following 3 or more injections with an intravitreal (IVT) anti-VEGF therapy in the preceding 5 months.
Summary analyses will include 12-weeks data from the Parent study, CLS1002-101, and 12-weeks data from this extension study, CLS1002-102, for a total of 24 weeks follow-up, for all participants enrolled into the extension study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled in and completed the Parent study, CLS1002-101, as part of Cohort 2 or Cohort 3 or Cohort 4.
排除标准
- •Received prohibited medication in the Parent study, CLS1002-
- •Enrolled in the Parent study CLS1002-101 as part of Cohort
- •Females of childbearing potential who are pregnant and or lactating.
研究组 & 干预措施
Cohort 2 (Low-mid Dose) Extension
Subjects who were administered by suprachoroidal injection 0.10 mg CLS-AX in cohort 2 of the parent study, CLS1002-101, will be followed for an additional 12 weeks following exit from the Parent study. No intervention will be administered in this extension study.
干预措施: CLS-AX (Drug)
Cohort 3 (High-mid Dose) Extension
Subjects who were administered by suprachoroidal injection 0.50 mg CLS-AX in cohort 3 of the parent study, CLS1002-101, will be followed for an additional 12 weeks following exit from the Parent study. No intervention will be administered in this extension study.
干预措施: CLS-AX (Drug)
Cohort 4 (High Dose) Extension
Subjects who were administered by suprachoroidal injection 1.0 mg CLS-AX in cohort 4 of the parent study, CLS1002-101, will be followed for an additional 12 weeks following exit from the Parent study. No intervention will be administered in this extension study.
干预措施: CLS-AX (Drug)
结局指标
主要结局
Number of Participants With Serious Adverse Events (SAEs)
时间窗: Day 1 to Week 24
The number of participants with serious adverse events (SAEs) reported between the administration of CLS-AX and study exit.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
时间窗: Day 1 to Week 24
The number of participants with treatment-emergent adverse events (TEAEs) reported between the administration of CLS-AX and study exit.
次要结局
- Number of Participants Receiving Additional Intravitreal (IVT) Aflibercept Injections(Day 1 to Week 24)
- Mean Change From Baseline in Central Subfield Thickness (CST) in the Study Eye(Weeks 4, 8, 12, 16, 20 and 24)
- Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye(Weeks 4, 8, 12, 16, 20 and 24)