NCT06990399招募中3 期
A Randomized, Double-masked, Sham-controlled, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal Tabirafusp Alfa (KSI-101) in Participants With Macular Edema Secondary to Inflammation (MESI) - PEAK
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 88
- 主要终点
- Mean change in BCVA
研究概览
简要总结
A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants with Macular Edema Secondary to Inflammation (MESI)
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
- •Macular Edema Secondary to Inflammation (MESI) with a central subfield thickness (CST) of ≥400 microns on SD-OCT in Study Eye.
- •Definitive presence of Intraretinal Fluid and/or Subretinal Fluid on SD-OCT in the Study Eye.
- •BCVA ETDRS score of ≥25 and ≤70 letters (between 20/40 and 20/320 Snellen equivalent) in the Study Eye.
- •Diagnosis of active or inactive non-infectious intraocular inflammation, acute or chronic in the Study Eye.
排除标准
- •Macular Edema in the Study Eye secondary to diabetic retinopathy, RVO, or wAMD.
- •Active or suspected ocular or periocular infection in either eye.
- •Any history of or active occlusive retinal vasculitis in either eye.
研究组 & 干预措施
Sham
Sham Comparator
Sham injection once every 4 weeks for 6 monthly doses followed by individualized sham dosing
干预措施: Sham Comparator (Other)
KSI-101 5 mg
Experimental
Intravitreal injection of KSI-101 5 mg once every 4 weeks for 6 monthly doses followed by individualized dosing
干预措施: KSI-101 (Drug)
KSI-101 10 mg
Experimental
Intravitreal injection of KSI-101 10 mg once every 4 weeks for 6 monthly doses followed by individualized dosing
干预措施: KSI-101 (Drug)
结局指标
主要结局
Mean change in BCVA
时间窗: Week 24
Mean change in BCVA from Day 1 to the average of Week 20 and Week 24.
次要结局
未报告次要终点
研究者
研究点 (88)
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