NCT06707753进行中（未招募）1 期
An Open-label, Nonrandomized, Single-arm, Single Dose, Dose-escalation Phase I/IIa Study to Evaluate the Safety and Tolerability of AL-001 Ophthalmic Injection in Subjects with Wet Age-related Macular Degeneration (wAMD)
Beijing Anlong Biopharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2023年9月11日最近更新:
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）
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Safety and tolerability
研究概览
简要总结
This Phase I/IIa study is designed to evaluate the safety, tolerability, preliminary pharmacodynamics and pharmacokinetics in patients with wet age-related macular degeneration. Eligible patients, who meet the inclusion/exclusion criteria and have shown an anatomic response to an anti-VEGF (Vascular Endothelial Growth Factor) injection, will receive a single dose of AL-001 administered via suprachoroidal space injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Age≥ 50 and ≤
- •The study eye was diagnosed with subfoveal active choroidal neovascularization (CNV) lesions secondary to wAMD.
- •Best Corrected Visual Acuity (BCVA) of study eye during screening, Early Treatment of Diabetic Retinopathy Study (ETDRS) letters≤73 and ≥
- •The subject or their legal representative agrees to participate in this study and signs a written ICF.
排除标准
- •Non-wAMD induced CNV or macular edema in the study eye.
- •Non-wAMD induced eye conditions that may affect central vision or medical history that may seriously affect central vision in the study eye.
- •Uncontrolled glaucoma in the study eye.
- •History of vitreoretinal surgery, antiglaucoma trabeculectomy, or other anti-glaucoma filtering surgery in the study eye.
- •Refractive interstitial opacity that significantly affects visual function assessment or fundus examination in the study eye.
- •Ametropia (high myopia or high hyperopia) > 8.0D in the study eye, or significant posterior scleral staphyloma in the study eye.
- •Malignant tumor in any eye, including but not limited to eye lymphoma or choroidal melanoma.
- •None of intraocular inflammation in the study eye.
- •Other conditions that may affect compliance or may not be suitable to participate in this trial in the opinion of investigator.
研究组 & 干预措施
AL-001 Dose 1
Experimental
Injection of low dose
干预措施: AL-001 (Drug)
AL-001 Dose 2
Experimental
Injection of medium dose
干预措施: AL-001 (Drug)
AL-001 Dose 3
Experimental
Injection of high dose
干预措施: AL-001 (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: Week 24
Incidence of adverse events (AEs) and serious adverse events (SAEs)
次要结局
- Evaluate the effect of AL-001 on BCVA(Week 52)
研究者
研究点 (1)
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