NCT05859776进行中（未招募）1 期
Phase 1/2a Study of the Safety and Bioactivity of AXT107 Injected Suprachoroidally in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
The goal of this clinical trial is to understand the safety of AXT107 injected suprachoroidally in participants with nAMD. The main question[s] it aims to answer are:
- Safety of the maximum tolerable dose of AXT107
- Bioactivity and duration of action of AXT107 injected suprachoroidally Participants will be injected with AXT107 and will be followed on a regular monitoring visits through 9 months post single 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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50 years of age or older
- •Presence of active subfoveal choroidal neovascularization (CNV) (any subtype) or juxtafoveal CNV with leakage affecting the fovea secondary to AMD and the area of the CNV lesion must beat least 50% of the total lesion size confirmed by the Investigator
- •Evidence of subretinal or intraretinal fluid or retinal cystic changes evidenced by Spectral Domain Optical Coherence Tomography (SD-OCT) at Screening accompanied by finding on SD- OCT suggestive of CNV secondary to AMD confirmed by the Investigator
- •BCVA in the study eye between 65 and 25 ETDRS letters (20/50 and 20/320 Snellen equivalent) at Baseline (Day 0)
- •BCVA of 34 ETDRS letters or better (20/200 or better Snellen equivalent) in the non-study eye at Baseline (Day 0)
- •Able and willing to give signed informed consent and follow study instructions
- •Has been/is a prior partial responder to an anti-VEGF agent
排除标准
- •Previously treated patients who are non-responders to anti-VEGF as determined by the Investigator
- •Any prior use of Brolucizumab; use of Aflibercept within 8 weeks or use of Ranibizumab or Bevacizumab within 6 weeks from Baseline (Day 0) in the study eye
- •Any concurrent disease that would require medical or surgical intervention during the study in the study eye (e.g., retinal detachment, significant cataract)
- •Any condition that may preclude improvement in visual acuity or affect the evaluation of the study eye after resolution of AMD (e.g., extensive macular hemorrhage ≥ 50% lesion size, media clarity insufficient to obtain quality images, presence of diabetic retinopathy)
- •Other causes of CNV (e.g., pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, and multifocal choroiditis) in the study eye confirmed by the Investigator
- •Chronic uveitis or ongoing clinically significant infection or inflammation (e.g., keratitis, scleritis) in either eye
研究组 & 干预措施
High Dose
Experimental
AXT107 0.500 mg/eye
干预措施: AXT107 High Dose (Drug)
Low Dose
Experimental
AXT107 0.125 mg/eye
干预措施: AXT107 Low Dose (Drug)
Mid Dose
Experimental
AXT107 0.250 mg/eye
干预措施: AXT107 Mid Dose (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: 40 Weeks
Primary Outcome Measure: 1.Safety as Assessed by change from baseline in Incidence of Adverse Events (AEs) Incidence of ocular (study eye) and systemic AEs \[Time Frame: Screening to Week 40\]
次要结局
- Mean Change in Central Subfield Thickness (CST)(40 Weeks)
- Visual Function Subgroup Analysis(Day 0 to Week 40)
- Mean Change in Visual Function(Day 0 to Week 40)
研究者
研究点 (4)
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