NCT06458595招募中1 期
A Phase I/II Study to Evaluate the Tolerability, Safety and Efficacy of KH658 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD).
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change in BCVA letter
研究概览
简要总结
KH658 is a adeno-associated virus (AAV) vector-based gene therapy for suprachoroidal space injection. The long-term, stable therapeutic protein after one time injection for nAMD could potentially reduce the treatment burden and maintain vision.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are willing and able to sign the informed consent form (ICF);
- •Female and male aged 50 to 85 years (inclusive) with nAMD;
- •Have previously received anti-VEGF treatment for nAMD, with documented response to anti-VEGF therapy and a minimum of 2 anti-VEGF IVT injections in the study eye in the 6 months prior to screening;
- •Have a ETDRS BCVA letter score of 83 to 19 (approximately 20/25 to 20/400 Snellen equivalent) in the study eye at Screening;
- •Have a ETDRS BCVA letter score of ≥19 in the fellow eye at Screening;
- •Females must be at least 1 year postmenopausal.
排除标准
- •Have any other cause of CNV (such as pathological myopia, etc.) in the study eye; or non-nAMD disease in the study eye judged by the investigator that could impact macular examination or affect central vision (such as diabetic retinopathy, central retinal vein occlusion, etc.);
- •Any condition preventing visual acuity improvement in the study eye, e.g. fovea scar, fibrosis or atrophy;
- •Have a subretinal hemorrhage that is either 50% or more of the total lesion area, or blood is greater than 1.0 mm2 under the fovea in the study eye at screening;
- •Have any vitreous hemorrhage or history of vitreous hemorrhage in the study eye;
- •Presence of an implant (excluding intraocular lens), opacification of the refractive medium or miosis that affects fundus examination;
- •Have a history of or presence of retinal detachment or choroidal detachment in the study eye.
研究组 & 干预措施
KH658
Experimental
干预措施: KH658 (Drug)
结局指标
主要结局
Change in BCVA letter
时间窗: Week 26
Tolerability and safety of KH658 in different dose levels
时间窗: Week 4， Week 26
次要结局
- Incidence of adverse events and adverse reactions(Week 4， 26， 38， 54)
- Annualized rate of supplemental injections(Week 54)
- Efficacy (BCVA, CRT)(Week 38， 54)
- Percentage of subjects free of rescue IVT therapy(Week 54)
- Number of supplemental injections(Week 54)
研究者
研究点 (1)
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