NCT05831007进行中（未招募）不适用
An Open Label Dose Escalation Clinical Trial to Evaluate the Safety and the Efficacy of LX102-C01 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 6 人开始时间: 2021年12月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Incidence of 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-C01 treatment of nAMD. This study will enroll subjects aged ≥ 50 years old to receive a single unilateral intravitreal (IVT) injection of LX102-C01 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
- •The study eye must have a best-corrected E-ETDRS visual acuity letter score of less than or equal to
- •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 serious adverse events (SAEs)
时间窗: 52 weeks
Incidence of serious adverse events (SAEs) within 52 weeks of LX102-C01 intravitreal injection at different doses
Incidence of adverse events (AEs)
时间窗: 52 weeks
Incidence of adverse events (AEs) within 52 weeks of LX102-C01 intravitreal injection at different doses
次要结局
- Mean change in BCVA from Baseline(24 weeks, 52weeks)
- Mean number of anti-VEGF injections over time(52 weeks)
- Change of quality of life scores (VFQ-25) from Baseline(52 weeks)
- Mean change in Central Subfield Thickness (CST) from Baseline(24 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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