Phase 1/2a Study of the Safety and Bioactivity of AXT-107 in Subjects With Diabetic Macular Edema (DME)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Safety as Assessed by Incidence of Adverse Events (AEs)
研究概览
简要总结
This study is an open-label, dose-escalating, 48-week study assessing the safety, tolerability, bioactivity and duration of action of a single intravitreal injection of 0.1 mg, 0.25 mg, or 0.5 mg AXT107 in approximately 18 subjects (up to 6 subjects per dose) with Diabetic Macular Edema (DME).
详细描述
Upon providing informed consent, subjects will be sequentially enrolled into the study. Decision regarding dose escalation will be based on the recommendation from the Data Monitoring Committee (DMC). The first 3 eligible subjects will receive the low dose of AXT107 injection. After the 3 low dose subjects complete a 7-day follow-up, the DMC will review their safety data. If an acceptable safety profile is determined by the DMC, 3 additional subjects will be enrolled to receive the mid dose of AXT107 injection. Upon completion of a 7-day follow-up, review of the safety data, and determination of an acceptable safety profile by the DMC for the mid dose subjects, 3 additional subjects will be enrolled to receive the high dose of AXT107 injection.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years of age or older with diabetic macular edema (DME) diagnosis secondary to diabetes mellitus Type 1 or 2
- •Best corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 65 to 23 in the study eye
- •Willing and able to comply with clinic visits and study-related procedures
- •Provide signed inform consent
排除标准
- •Any signs of high risk proliferative diabetic retinopathy in the study
- •Previously-treated patients who are not responders to anti-VEGF
- •Panretinal laser photocoagulation within 6 months and macular laser photocoagulation with 3 months of screening in the study eye
- •Note: Other inclusion/exclusion criteria apply.
研究组 & 干预措施
Low Dose
AXT107 0.1 mg/eye
干预措施: AXT107 0.1 mg (Drug)
Mid Dose
AXT107 0.25 mg/eye
干预措施: AXT107 0.25 mg (Drug)
High Dose
AXT107 0.5 mg/eye
干预措施: AXT107 0.5 mg (Drug)
结局指标
主要结局
Safety as Assessed by Incidence of Adverse Events (AEs)
时间窗: Screening to Week 48
Incidence of ocular (study eye) and systemic AEs
次要结局
未报告次要终点