NCT06996080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) - PINNACLE
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
- 300
- 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 ≥320 and <400 microns on SD-OCT and a BCVA score of ≥25 and ≤78 ETDRS letters (between ~20/25 and 20/320 Snellen equivalent) in the Study Eye.
- •Definitive presence of Intraretinal Fluid and/or Subretinal Fluid on SD-OCT in the Study Eye.
- •Diagnosis of active or inactive non-infectious intraocular inflammation, acute or chronic in the Study Eye.
排除标准
- •ME in the Study Eye secondary to diabetes, 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)
Loading locations...
相似试验
招募中
3 期
A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants With Macular Edema Secondary to Inflammation (MESI) - PEAKNCT06990399Kodiak Sciences Inc600
已完成
3 期
A Study to Confirm the Efficacy and Safety of K-161 Ophthalmic Solution for Treatment of Moderate to Severe Dry Eye DiseaseDry Eye DiseaseNCT05403827Kowa Research Institute, Inc.644
已完成
3 期
Safety and Efficacy of KPI-121 in Subjects With Postsurgical InflammationOcular Infections, Irritations and InflammationsNCT02163824Kala Pharmaceuticals, Inc.380
终止
3 期
A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Participants With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy (NPDR)Non-proliferative Diabetic RetinopathyNCT05066230Kodiak Sciences Inc253
已完成
3 期
Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation and PainPost Surgical Ocular Inflammation and PainNCT02793817Kala Pharmaceuticals, Inc.520