NCT06718816招募中不适用
A Long-term Follow-up Study to Evaluate the Safety and Effectivity of AL-001 Ophthalmic Injection in Subjects with Wet Age-related Mecular 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: 2024年12月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- AE/SAE
研究概览
简要总结
This study is designed to evaluate long-term safety and efficacy of AL-001 ophthalmic injection following suprachoroidal space(SCS) administration in subjects with wAMD. Eligible patients, are those who were previously enrolled in a clinical study in which they received a single dose of AL-001 administered via suprachoroidal space injection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •The subjects enrolled in AL-001 study and received AL-001 ophthalmic injection.
- •The subject or their legal representative agrees to participate in this study and signs a written ICF.
- •The subjects are willing and able to follow planned visits and procedures.
排除标准
- 未提供
结局指标
主要结局
AE/SAE
时间窗: month 48
Incidence and severity of ophthalmic and systematic AE/SAE.
次要结局
- Best Corrected Visual Acuity(BCVA)(month 48)
- The mean and frequency of anti-VEGF injections(month 48)
研究者
研究点 (1)
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