A Phase 2 Evaluation of Tonabersat for Diabetic Macular Edema (Protocol AN)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 128
- 试验地点
- 28
- 主要终点
- Mean change in central subfield thickness
研究概览
简要总结
This randomized clinical trial will evaluate the effect of tonabersat compared with placebo on central subfield thickness (CST) in eyes with center-involved diabetic macular edema (CI-DME) and good visual acuity.
详细描述
The primary objective is to assess the effects of tonabersat, an orally administered Connexin43 hemichannel inhibitor, on central subfield thickness (mean change) compared with placebo in eyes with CI-DME and good visual acuity at 6 months.
Exploratory objectives will evaluate biomarkers of kidney function for potential benefit. Furthermore, this phase 2 study is being conducted to determine whether the conduct of a phase 3 trial has merit and provide information on outcome measures needed to design a phase 3 trial.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
干预措施: Placebo (Other)
Tonabersat (80 mg)
干预措施: Tonabersat (Drug)
结局指标
主要结局
Mean change in central subfield thickness
时间窗: 6 months
次要结局
- Mean change in retinal volume from baseline(6 months)
- Percentage of eyes central subfield thickness below optical coherence machine- and sex-specific threshold for DME and at least a 10% decrease from baseline(6 months)
- Mean change in visual acuity from baseline(6 months)
- Percentage of eyes receiving other treatment for DME prior to the 6 month visit(6 months)