A Phase 2a, Randomized, Double-masked, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of SNP318 in Patients With Diabetic Macular Edema
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Safety Events
研究概览
简要总结
The objective of this study is to assess the safety, efficacy, and tolerability of SNP318 in patients with DME.
详细描述
DME is a prevalent complication of diabetic retinopathy, resulting in fluid accumulation in the macula due to the leakage of fluid from damaged retinal blood vessels. It is a leading cause of vision impairment in diabetic patients and can significantly affect quality of life if left untreated. SNP318 is a small molecule and selective inhibitor of Lp-PLA2. It plays a critical role in the regulation of the pro-neuroinflammatory pathway, which is implicated in the pathogenesis of multiple diseases.
This is a phase 2a, randomized, double-masked, placebo-controlled, multicenter study to evaluate the safety, tolerability, and efficacy of SNP318 in patients with Diabetic Macular Edema. Participants who consent will undergo a 3-week screening period to evaluate their eligibility. Once enrolled, participants will be randomized to receive orally either SNP318 or placebo for up to 12 weeks, and then enter into a 4-week follow up period.
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
- •Confirmed diabetes mellitus Type 1 or Type 2, with stable glycemic control
- •Center-involved DME with CST >=320 µm (Study eye)
- •BCVA between 82 and 25 letters, inclusive (Study eye)
- •BCVA score ≥ 25 letters (Non-study eye)
排除标准
- •1. Use of the last intravitreal anti-VEGF injection in the study eye within 90 days prior to Screening
研究组 & 干预措施
SNP318
干预措施: SNP318 (Drug)
Matching Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Safety Events
时间窗: 12 weeks
Incidence of adverse events (AEs) / serious adverse events (SAEs)
Central Subfield Thickness (CST)
时间窗: 12 weeks
Spectral Domain Optical Coherence Tomography (SD-OCT) measurements of CST
次要结局
- Visual Acuity(12 weeks)
- Pharmacokinetics (PK)(12 weeks)
- Pharmacodynamics(12 weeks)