NCT06198413进行中（未招募）1 期
A Dose-Escalation Study of LX102 Gene Therapy for Neovascular Age-Related Macular Degeneration (nAMD)
Innostellar Biotherapeutics Co.,Ltd3 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2023年2月27日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
- 试验地点
- 3
- 主要终点
- Incidence of adverse events (AEs) and serious adverse events (SAEs)
研究概览
简要总结
The goal of this study is to evaluate the safety and efficacy of LX102 gene therapy for nAMD.
详细描述
This study will enroll subjects aged ≥ 50 years old to receive a single unilateral subretinal injection of LX102 to evaluate its safety and efficacy.
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
- •Willing to sign the informed consent, and willing to attend follow-up visits.
- •Diagnosis of active CNV secondary to neovascular AMD
- •BCVA ETDRS letters between 5 and 63
- •Subjects must have received a minimum of 2 injections within 6 months prior to screening
- •Demonstrated a meaningful response to anti-VEGF therapy
排除标准
- •CNV or macular edema in the study eye secondary to diseases other than nAMD
- •Retinal detachment, uveitis, uncontrolled glaucoma in the study eye, or any condition preventing visual acuity improvement
- •Acute coronary syndrome, myocardial infarction or coronary artery revascularization, CVA, TIA in the last 6 months
- •Uncontrolled hypertension defined as average SBP ≥160 mmHg or an average DBP ≥100 mmHg
- •Uncontrolled diabetes defined as HbA1c >7.5%
结局指标
主要结局
Incidence of adverse events (AEs) and serious adverse events (SAEs)
时间窗: 52 weeks
Incidence of ocular and systemic adverse events (AEs) and serious adverse events (SAEs) following LX102 subretinal injection
Incidence of dose-limiting toxicity (DLT)
时间窗: 4 weeks
Incidence of dose-limiting toxicity (DLT) following LX102 subretinal injection at different doses
次要结局
- Mean change in Central Subfield Thickness (CST) from Baseline(12 weeks, 36 weeks 52 weeks)
- Mean time from LX102 administration to anti-VEGF rescue injection for the first time(52 weeks)
- Percentage of participants requiring anti-VEGF rescue injection(52 weeks)
- Mean change in BCVA from Baseline(12 weeks, 36 weeks 52 weeks)
- Mean number of anti-VEGF rescue injections(52 weeks)
研究者
研究点 (3)
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