NCT05695417进行中（未招募）1 期
A Phase 1B, Multicenter, Double-Masked, Randomized, Parallel Group Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI (Axitinib Implant) for Intravitreal Injection in Subjects With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 21
- 试验地点
- 5
- 主要终点
- Safety and Tolerability
研究概览
简要总结
Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI in Subjects with Moderately Severe to Severe Non-proliferative Diabetic Retinopathy
详细描述
Multicenter, Double-Masked, Randomized, Parallel Group Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI (axitinib implant) for Intravitreal Injection in Subjects with Moderately Severe to Severe Non-proliferative Diabetic Retinopathy
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, Investigator)
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
- •Are at least 18 years of age or older
- •Moderately severe to severe NPDR in the study eye defined as: DRSS levels of 47 or 53 as determined by the reading center
- •Diabetes type 1 or 2
- •BCVA ETDRS letter score in the study eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better)
排除标准
- •DME within 6 months involving the center of the macula in the study eye
- •Presence of DME threatening the center (within 200 microns) of the macula in the study eye
- •OCT CSFT of ≥320 μm in the study eye
研究组 & 干预措施
OTX-TKI
Active Comparator
干预措施: OTX-TKI (Drug)
Sham
Sham Comparator
干预措施: Sham (Drug)
结局指标
主要结局
Safety and Tolerability
时间窗: Baseline up to Week 52
Frequency of treatment emergent adverse events
次要结局
- Central subfield thickness changes(Baseline up to Week 52)
- Diabetic Retinopathy Severity Scale (DRSS) changes(Baseline up to Week 52)
- Change in Best Corrected Visual Acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score(Baseline up to Week 52)
- Rescue Therapy(Baseline up to Week 52)
研究者
研究点 (5)
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