NCT06492876招募中1 期
A Dose-escalation and Dose-expanded Phase I/II Clinical Study to Evaluate the Safety, and Efficacy of FT-003 in Subjects With DME
适应症
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 Diabetic Macular Edema (DME). The study was divided into two phases, Phase 1 dose escalation and Phase II dose expansion.
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
- 18 Years 至 74 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 18-74 years old at the time of signing the ICF;
- •Clinically diagnosed with CI-DME;
- •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 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: 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)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
1 期
Gene Therapy(FT-003) for Wet AMDNeovascular Age-related Macular DegenerationNCT06492863Frontera Therapeutics78
终止
1 期
A Phase 1 Study Evaluating CB-5083 in Subjects With Lymphoid Hematological MalignanciesLymphoid Hematological MalignanciesRelapsed and Refractory Multiple MyelomaNCT02223598Cleave Biosciences, Inc.120
终止
2 期
Study Exploring Safety, Pharmacokinetic and Pharmacodynamic of BN82451 in Male Huntington's Disease PatientsHuntington's DiseaseNCT02231580Ipsen17
招募中
1 期
Study of SRP-1001 in Adult and Adolescent Participants With Facioscapulohumeral Muscular Dystrophy Type 1Muscular Dystrophy, FacioscapulohumeralNCT06131983Sarepta Therapeutics, Inc.60
已完成
1 期
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of C16TR for Inhalation With Tyvaso® Cohort in Healthy ParticipantsHealthy VolunteersNCT06193031Insmed Incorporated24