Phase 1/2a Study of the Safety and Bioactivity of AXT107 in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Number of Participants Assessed by Incidence of Adverse Events (AEs)
研究概览
简要总结
This 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 nAMD.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 50 years of age or older diagnosed in the study eye with subfoveal choroidal neovascularization (CNV) or juxtafoveal CNV secondary to AMD
- •Best corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 65 to 10 in the study eye
- •Willing and able to comply with clinic visits and study-related procedures
- •Provide signed inform consent
排除标准
- •Macular edema or CMV secondary to any causes other than AMD in the study eye
- •Previously-treated patients who are not responders to anti-VEGF
- •Any condition that may preclude improvement in visual acuity in the study eye
- •Previous vitreoretinal surgery, filtration surgery, and cataract surgery within 3 months 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
Number of Participants Assessed by Incidence of Adverse Events (AEs)
时间窗: Screening to Week 48
Incidence of ocular (study eye) and systemic adverse events (AEs)
次要结局
未报告次要终点