NCT03295877已完成1 期
A Phase I, Multicenter, Open-Label, Single-Dose, Dose-Escalation, and Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of RO7171009 in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 12
- 主要终点
- Safety and Tolerability of the Study Drug: Rate of Adverse Events
研究概览
简要总结
This Phase 1, open-label, multicenter study will investigate the safety and tolerability of RO7171009 following single and multiple intravitreal (ITV) administrations in patients with GA secondary to AMD. The study consists of two stages: Single Dose-Escalation (SAD) and Multiple-Dose (MD) stages.
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
- •Participants aged greater than or equal to (>/=) 50 years
- •Well demarcated area(s) of GA secondary to AMD with no evidence of prior or active choroidal neovascularization (CNV) in study eye
排除标准
- •Ocular Exclusion Criteria, Study Eye:
- •History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
- •Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, or proliferative diabetic retinopathy
- •Prior treatment with Visudyne®, external beam radiation therapy (for intraocular conditions), or transpupillary thermotherapy
- •Ocular Exclusion Criteria (Both Eyes):
- •GA in either eye due to causes other than AMD
- •Evidence of prior or active CNV
- •Previous participation in interventional clinical trials for GA or dry AMD, except for vitamins and minerals, irrespective of the route of administration (i.e., ocular or systemic) within the last 6 months
研究组 & 干预措施
RO7171009: SAD
Experimental
Patients will receive a single dose of RO7171009, in multiple escalating cohorts.
干预措施: RO7171009 (Drug)
RO7171009: MD
Experimental
Patients will receive RO7171009 at maximum tolerated dose (MTD), identified during the SAD stage for three doses.
干预措施: RO7171009 (Drug)
结局指标
主要结局
Safety and Tolerability of the Study Drug: Rate of Adverse Events
时间窗: Through study completion or early study discontinuation (overall 12-20 weeks)
次要结局
- Serum Concentration of RO7171009(Through study completion or early study discontinuation (overall 12-20 weeks))
研究者
研究点 (12)
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