An Open-label, Multy-center, Dose-escalation Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of FT-003 in Subjects With Diabetic Macular Edema
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Safety and tolerability after FT-003 injection
研究概览
简要总结
FT-003 is a gene therapy product developed for the treatment of central involvement diabetic macular edema (CI-DME). Diabetic retinopathy is one of the most common microvascular complications of diabetes mellitus, and diabetic macular edema is the main cause of vision loss in patients with diabetic retinopathy. In the latest guidelines, anti-VEGF therapy is preferred for CI-DME. Administration of FT-003 has the potential to treat CI-DME by providing intraocular protein which is durable expressed in therapeutic level. FT-003 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with CI-DME receiving anti-VEGF therapy in clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Subjects that are willing and able to follow study procedures;
- •Female or male patients ≥18 years old at the time of signing the ICF;
- •Clinically diagnosed with CI-DME
- •HbA1c≤10%
- •The best corrected visual acuity (BCVA) of the studied eye is ≤ 73 letters
排除标准
- •Presence of any other intraocular diseases other than CI-DME in the studied eye that would affect the improvement of visual acuity and require treatment during the study for prevention or treatment of visual loss, as judged by the investigator
结局指标
主要结局
Safety and tolerability after FT-003 injection
时间窗: Whthin 52 weeks after administration
Incidence and severity of AE (Common Terminology Criteria for Adverse Events 5.0)
次要结局
- Preliminary effectiveness after FT-003 injection(Whthin 52 weeks after administration)