SAPPHIRE: A Randomized, Masked, Controlled Trial To Study The Safety And Efficacy Of Suprachoroidal CLS-TA In Conjunction With Intravitreal Aflibercept In Subjects With Retinal Vein Occlusion
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 460
- 试验地点
- 108
- 主要终点
- Proportion of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS)
研究概览
简要总结
This is a Phase 3, multicenter, randomized, masked, controlled, parallel group study of 12 months duration in treatment naïve subjects with RVO.
详细描述
A randomized, masked, controlled trial to study the safety and efficacy of suprachoroidal CLS-TA in conjunction with intravitreal aflibercept in subjects with 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
- •Has a clinical diagnosis of RVO in the study eye
- •Has a CST of ≥ 300 µm in the study eye
- •Has an ETDRS BCVA score of ≥ 20 letters read and ≤ 70 letters read in the study eye;
- •Is naïve to local pharmacologic treatment for RVO in the study eye;
排除标准
- •Any active ocular disease or infection in the study eye other than RVO
- •History of glaucoma, intraocular pressure > 21 mmHg or ocular hypertension requiring more than one medication
- •Any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study
- •Any evidence of neovascularization in the study eye
研究组 & 干预措施
Active
IVT aflibercept (2 mg/0.05 mL) + CLS-TA (4 mg/100 µL) SC injections
干预措施: suprachoroidal CLS-TA (Drug)
Active
IVT aflibercept (2 mg/0.05 mL) + CLS-TA (4 mg/100 µL) SC injections
干预措施: IVT aflibercept (Drug)
Control
IVT aflibercept (2 mg/0.05 mL) + sham SC procedure
干预措施: suprachoroidal sham (Drug)
Control
IVT aflibercept (2 mg/0.05 mL) + sham SC procedure
干预措施: IVT aflibercept (Drug)
结局指标
主要结局
Proportion of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS)
时间窗: 2 months
Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement.
次要结局
- Mean Change From Baseline in Best Corrected Visual Acuity(6 months)
- Mean Change From Baseline in Central Subfield Thickness(6 months)