NCT05986864招募中1 期
Phase I/II Study to Evaluate the Safety and Preliminary Efficacy of SKG0106 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)
Skyline Therapeutics (US) Inc.13 个研究点 分布在 2 个国家目标入组 68 人开始时间: 2024年2月23日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 68
- 试验地点
- 13
- 主要终点
- Type, severity, and incidence of ocular and systemic adverse events (AEs)
研究概览
简要总结
This is a phase 1/2 clinical study to evaluate the safety, preliminary efficacy, immunogenicity, and pharmacokinetic (PK) characteristics of SKG0106 in subjects with nAMD. Based on results from the phase 1 dose escalation study, the phase 2 expansion study will be conducted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Voluntary and able to sign a dated ICF prior to any study-related procedures and able to complete the study as required by the protocol;
- •Aged ≥ 50 years at screening;
- •Diagnosis of nAMD as determined by the PI;
- •Active CNV lesions secondary to age-related macular degeneration (AMD);
- •Subjects must have been responsive to anti-VEGF therapy as assessed by the PI prior to study treatment.
排除标准
- •Any active intraocular or periocular infection or active intraocular inflammation (e.g., infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in the study eye at baseline;
- •Retinal pigment epithelial tear in the study eye at screening;
- •Current vitreous hemorrhage in the study eye or history of vitreous hemorrhage within 4 weeks prior to baseline;
- •Any condition that, in the opinion of the investigator, may limit visual acuity improvement in the study eye;
- •History of retinal detachment or active retinal detachment in the study eye;
- •Any prior gene therapy.
研究组 & 干预措施
Phase I: High dose
Experimental
SKG0106 One-Time Intraocular Injection Dose Level 3
干预措施: SKG0106 (Genetic)
Phase I: Low dose
Experimental
SKG0106 One-Time Intraocular Injection Dose Level 1
干预措施: SKG0106 (Genetic)
Phase I: Medium dose
Experimental
SKG0106 One-Time Intraocular Injection Dose Level 2
干预措施: SKG0106 (Genetic)
结局指标
主要结局
Type, severity, and incidence of ocular and systemic adverse events (AEs)
时间窗: 52 Weeks
Characteristics of dose limiting toxicities (DLTs)
时间窗: 4 Weeks
次要结局
- Mean change from baseline in best corrected visual acuity (BCVA) at each visit(52 Weeks)
- Mean change from baseline in central subfield thickness (CST) at each visit(52 Weeks)
- Mean change from baseline in patient-reported outcome (VFQ-25) scale score at each visit(52 Weeks)
研究者
研究点 (13)
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