A Dose-escalation and Dose-expanded Phase I/II Clinical Study to Evaluate the Safety, and Efficacy of FT-003 in Subjects With Wet AMD
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Safety and tolerability after FT-003 injection
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety, tolerability and efficacy of disposable vitreous injection of FT-003 in subjects with neovascular age-related Macular Degeneration (nAMD). The study was divided into two phases, Phase 1 dose escalation and Phase II dose expansion.
详细描述
FT-003 is a gene therapy product developed for the treatment of neovascular age-related macular degeneration (nAMD). Neovascular AMD is the main cause of blindness among elderly individuals. The available therapies for treating nAMD require life-long intravitreal (IVT) injections every 4-12 weeks to maintain efficacy. Administration of FT-003 has the potential to treat nAMD by providing durable expression of therapeutic levels of intraocular protein and maintaining the vision of patients. FT-003 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with nAMD 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
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（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 50-80 years old at the time of signing the ICF;
- •Clinically diagnosed with nAMD;
- •Presence of active CNV
- •The best corrected visual acuity (BCVA) of the studied eye is 24-73 letters;
排除标准
- ••Presence of any other intraocular diseases other than nAMD 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: At Week 12
Incidence and severity of AE (Common Terminology Criteria for Adverse Events 5.0)
次要结局
- To evaluate the efficacy after FT-003 injection(At Week 24)