NCT04014777已完成1 期
A Phase 1, Multicenter, Open-Label, Single-Dose and Multiple-Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Intravitreal Injections of NGM621 in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
NGM Biopharmaceuticals, Inc7 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年7月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 7
- 主要终点
- Incidence and Severity of Ocular and Systemic Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
This is a multi-center evaluation of NGM621 in an open-label, single-dose and multiple-dose escalation study in participants with Geographic Atrophy secondary to Age-related Macular Degeneration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •GA lesion size in the study eye of >=2.5 mm² as assessed by the central reading center
- •BCVA - 54 to 4 letters (20/80 to 20/400 Snellen equivalent) using the standard ETDRS (Early Treatment of Diabetic Retinopathy Study) in the study eye at the Screening and Baseline visits; the fellow eye must have a BCVA of at least 69 letters (Snellen equivalent 20/40) at the Screening and Baseline visits
排除标准
- •GA in either eye because of cause other than AMD
- •History or evidence of glaucoma or ocular hypertension in either eye as defined by investigator
- •Visual impairment in the study eye due to causes other than GA
- •Spherical equivalent of the refractive error in the study eye demonstrating more than -6 Diopters of myopia (prior to cataract or refractive surgery)
- •Other protocol-defined inclusion/exclusion criteria could apply.
结局指标
主要结局
Incidence and Severity of Ocular and Systemic Treatment-Emergent Adverse Events (TEAEs)
时间窗: 12 weeks
The number and percent of patients reporting treatment emergent adverse events (TEAEs) by cohort.
次要结局
- Serum Concentration of NGM621(12 weeks)
研究者
研究点 (7)
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