Phase 2 Study To Determine the Safety and Efficacy of TTHX1114(NM141) on the Regeneration and Migration of Corneal Endothelial Cells in Patients Undergoing DWEK/DSO
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 11
- 主要终点
- Best Corrected Visual Acuity
研究概览
简要总结
Open label, single-treatment, with a concurrent non-treatment control
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Fuchs Endothelial Cell Dystrophy (FECD) diagnosed more than 6 months
- •Scheduled for DWEK/DSO with a planned central descemetorhexis of approx 4 to 5 mm
- •Subjects in Group 2 must have a stable Fellow Eye with adequate function
排除标准
- •Secondary corneal/ocular pathology in the Study Eye
- •Prior refractive surgery in the Study Eye
- •Prior exposure to TTHX1114
研究组 & 干预措施
Group 2 TTHX1114 in combination with DWEK/DSO
Study subjects in Group 2 will receive TTHX1114 (5 injections) and undergo DWEK/ DSO
干预措施: TTHX1114(NM141) (Drug)
Group 3 TTHX1114 in combination with DWEK/DSO
Study subjects in Group 3 will receive TTHX1114 (1 injection) and undergo DWEK/ DSO
干预措施: TTHX1114(NM141) (Drug)
Group 1a
Study subjects in Group 1a will consist of subjects in Group 1 if not recovered from DWEK/ DSO by Day 84 and will receive TTHX1114 (5 injections)
干预措施: TTHX1114(NM141) (Drug)
Group 3a
Study subjects in Group 3a will consist of subjects who had participated in in Group 3 if not recovered from DWEK/ DSO by the median time observed in Group 2 and will receive TTHX1114 (4 injections)
干预措施: TTHX1114(NM141) (Drug)
结局指标
主要结局
Best Corrected Visual Acuity
时间窗: Day 28
Change from baseline
次要结局
未报告次要终点