A Randomized, Masked, Multicenter Study to Assess the Safety and Efficacy of CLS-TA, Triamcinolone Acetonide Injectable Suspension in the Treatment of Subjects With Macular Edema Following Uveitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 主要终点
- Change From Baseline in Central Subfield Thickness, Measured Using Optical Coherence Tomography, After Treatment With CLS-TA in Subjects With Macular Edema Following Uveitis
研究概览
简要总结
The study is designed to evaluate the safety and efficacy of triamcinolone acetonide, CLS-TA, in subjects with macular edema following non-infectious uveitis. A single suprachoroidal injection of one of two doses of CLS-TA will each be evaluated in subjects with macular edema following non-infectious uveitis.
详细描述
This is a Phase 2, randomized, masked, multicenter study to assess the safety and efficacy of two different doses of CLS-TA in the treatment of subjects with macular edema following non-infectious uveitis. Each subject will receive a single suprachoroidal injection of CLS-TA.
The subjects enrolled in this study will be chosen from subjects with macular edema following non-infectious uveitis. A single injection will be administered via the Clearside microinjector into the suprachoroidal space. The dose injected will either be 4 mg or 0.8 mg of CLS-TA in a total volume of 100 μL. The dose they receive will depend on what their randomization code dictates.
Subjects will be monitored for safety and efficacy for approximately 8 weeks following treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •diagnosis of noninfectious uveitis
- •diagnosis of macular edema associated with noninfectious uveitis
排除标准
- •any ocular trauma within the immediate 6 months prior to treatment
- •any photocoagulation or cryotherapy in the 6 months prior to treatment
- •any IVT injection of anti-VEGF treatment in the 2 months prior to treatment
- •any eye diseases other than uveitis and ME that could compromise central visual acuity
- •any previous suprachoroidal injection of triamcinolone acetonide in the study eye
研究组 & 干预措施
4 mg CLS-TA
Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA
干预措施: 4 mg CLS-TA (Drug)
0.8 mg CLS-TA
Single unilateral, suprachoroidal injection of 8 mg/mL (0.8 mg in 100 µL) of CLS-TA
干预措施: 0.8 mg CLS-TA (Drug)
结局指标
主要结局
Change From Baseline in Central Subfield Thickness, Measured Using Optical Coherence Tomography, After Treatment With CLS-TA in Subjects With Macular Edema Following Uveitis
时间窗: 2 months
次要结局
未报告次要终点