A Phase 2, Randomized Controlled, Open-Label Study to Establish the Safety and Efficacy of LX102 in Patients With Neovascular Age-related Macular Degeneration (nAMD) (VENUS)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 11
- 主要终点
- Mean change from baseline in Best Corrected Visual Acuity (BCVA)
研究概览
简要总结
The goal of this study is to evaluate the overall safety and efficacy of LX102 gene therapy for nAMD.
详细描述
In this Phase 2, multi-center, randomized controlled study, subjects will be randomized to receive one of the two dose levels of LX102 (n=20 for each dose level), or aflibercept (n=10).
Safety, tolerability, and efficacy will be evaluated for a period of approximately 1 year from baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 89 Years（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.
- •Age ≥ 50, and ≤
- •Diagnosis of active CNV secondary to neovascular AMD.
- •BCVA ETDRS letters between 19 and
- •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.
- •Absence of RPE tear at Screening.
- •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%.
研究组 & 干预措施
LX102 Dose 1
LX102 will be administered at the assigned dose level as a single dose subretinal injection on Day 0
干预措施: LX102 subretinal injection (Genetic)
LX102 Dose 2
LX102 will be administered at the assigned dose level as a single dose subretinal injection on Day 0
干预措施: LX102 subretinal injection (Genetic)
Control group
Aflibercept at a fixed regimen will be administered.
干预措施: Aflibercept intravitreal injection (Biological)
结局指标
主要结局
Mean change from baseline in Best Corrected Visual Acuity (BCVA)
时间窗: 36 weeks
BCVA measured by ETDRS
次要结局
- Incidence of adverse events (AEs) and serious adverse events (SAEs)(36 weeks, 52 weeks)
- Mean change in Central Subfield Thickness (CST) from Baseline(36 weeks, 52 weeks)
- Durability of LX102 treatment(52 weeks)
- Mean change from baseline in Best Corrected Visual Acuity (BCVA)(52 weeks)