TANZANITE: Safety and Efficacy of Suprachoroidal CLS-TA in Combination With Intravitreal Aflibercept in Subjects With Macular Edema Following Retinal Vein Occlusion
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 46
- 主要终点
- Total Number of Times a Subject Qualifies to be Administered IVT Aflibercept in Each Arm
研究概览
简要总结
A phase 2, multicenter, randomized, active-controlled, masked, parallel arm study designed to evaluate the safety and efficacy of a single suprachoroidal injection of CLS-TA, triamcinolone acetonide injectable suspension, given along with an intravitreal (IVT) injection of aflibercept compared to IVT aflibercept alone in subjects with retinal vein occlusion (RVO).
详细描述
A randomized, masked, controlled trial of safety and efficacy of suprachoroidal CLS-TA in combination with intravitreal aflibercept in subjects with macular edema following retinal vein occlusion
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
- Triple (Participant, Care Provider, 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 macular edema following RVO
- •History of ME ≤ 12 months
- •20-70 letters inclusive BCVA using ETDRS
排除标准
- •has had an IVT injection of anti-VEGF for RVO in the study eye
- •has had a corticosteroid injection in the past 3 months in the study eye
- •any uncontrolled ophthalmic condition in the study eye other than RVO
研究组 & 干预措施
4 mg CLS-TA + IVT aflibercept
Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA following a 2 mg intravitreal injection of aflibercept
干预措施: 4 mg CLS-TA (Drug)
4 mg CLS-TA + IVT aflibercept
Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA following a 2 mg intravitreal injection of aflibercept
干预措施: IVT aflibercept (Drug)
sham + IVT aflibercept
Single unilateral, suprachoroidal sham procedure following a 2 mg intravitreal injection of aflibercept
干预措施: Sham (Drug)
sham + IVT aflibercept
Single unilateral, suprachoroidal sham procedure following a 2 mg intravitreal injection of aflibercept
干预措施: IVT aflibercept (Drug)
结局指标
主要结局
Total Number of Times a Subject Qualifies to be Administered IVT Aflibercept in Each Arm
时间窗: 3 months
次要结局
未报告次要终点