MAGNOLIA: Multi-Center, Non-Interventional Extension Study of the Safety and Efficacy of CLS-TA for the Treatment of Macular Edema Associated With Non-Infectious Uveitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 16
- 主要终点
- Time to Additional Therapy for Uveitis
研究概览
简要总结
This study is a non-interventional, observational extension of the Parent study, CLS1001-301 (NCT02595398). The purpose of this study is to characterize the continued clinical benefit(s) regarding safety and efficacy of suprachoroidally administered CLS-TA, triamcinolone acetonide injectable suspension, for the treatment of macular edema associated with non-infectious uveitis.
详细描述
This is a non-interventional, observation extension study of up to 6 months for subjects completing the Parent study, CLS1001-301 (NCT02595398). The Parent study is a Phase 3, multicenter study to assess the safety and efficacy of 4 mg of CLS-TA administered via suprachoroidal injection compared to a sham procedure in the treatment of subjects with macular edema associated with non-infectious uveitis.
The design of the Extension study includes 4 clinic visits over a maximum of 24 weeks. Subject eligibility will be established at Visit 1 during the crossover day from the Parent study to the extension study (Day 0). Follow-up visits will be conducted every 6 weeks up to 24 weeks (Visit 4). At Visit 4, subjects will have a final evaluation conducted 24 weeks following study entry (48 weeks from Parent study randomization).
This study was initiated prior to the completion of the parent study, therefore treatment assignment was masked prior to study entry.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled in the Parent study, CLS1001-301, through Visit 8/Month 6
- •Willing and able to provide written informed consent prior to any study procedures; willing to comply with the instructions and attend all scheduled study visits
排除标准
- •Received additional therapy for the treatment of uveitis or prohibited medication
- •Require additional therapy for the treatment of uveitis or prohibited medication at the time of the Crossover visit
研究组 & 干预措施
4 mg CLS-TA Suprachoriodal Injection
Those subjects randomized to the CLS-TA 4 mg arm in CLS1001-301 (NCT02595398) and who completed participation without receiving additional therapy. No study drug was administered during this study.
干预措施: 4 mg CLS-TA Suprachoriodal Injection (Drug)
Sham procedure
Those subjects randomized to the sham procedure arm in CLS1001-301 (NCT02595398) and who completed participation without receiving additional therapy. No study drug was administered during this study.
干预措施: Sham procedure (Drug)
结局指标
主要结局
Time to Additional Therapy for Uveitis
时间窗: 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year
This time to event outcome was calculated as the number of days between the date of initiation of additional therapy for uveitis and the date of first treatment in the Parent study CLS1001-301 (NCT02595398).
次要结局
- Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events(6 months following exit from Parent study)
- Mean Change From Baseline in Central Subfield Thickness(6 months following exit from Parent study)
- Mean Change From Baseline in Best Corrected Visual Acuity(6 months following exit from Parent study)