NCT07053358招募中1 期
An Exploratory Clinical Study Evaluating LX111 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD)
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年7月2日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Adverse events and serious adverse events in the eyes and throughout the body within 364 days after LX111 treatment
研究概览
简要总结
The goal of this study is to evaluate the safety and efficacy of LX111 treatment of nAMD. This study will enroll subjects aged ≥ 50 vears old to receive a single unilateral intravitreal (lVT) injection of LX111 to evaluate its safety and efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（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 and demonstrated a meaningful response to anti-VEGF therapy
- •Male subjects whose partner is a fertile female or female subjects who are fertile, agree to take effective contraceptive measures from the screening period until the last follow-up.
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 >8.0% within 28 days prior to screening
研究组 & 干预措施
LX111 intravitreal injections
Experimental
干预措施: LX111 Injection (Genetic)
结局指标
主要结局
Adverse events and serious adverse events in the eyes and throughout the body within 364 days after LX111 treatment
时间窗: 52 weeks
Incidence of adverse events and serious adverse events within 52 weeks of LX111 intravitreal injection in each dose group.
Dose Limiting Toxicity
时间窗: 4 weeks
The incidence of DLT in each dose group.
次要结局
- The percentage of subjects who received anti-VEGF supplemental injection within 52 weeks after LX111 treatment(52 weeks)
- Mean changes in BCVA from Baseline(12 weeks, 36 weeks, 52 weeks)
- Mean changes in Central Subfield Thickness (CST) from Baseline(12 weeks, 36 weeks, 52 weeks)
研究者
Xiaodong Sun
PhD
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
研究点 (1)
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