NCT02061865已完成1 期
Phase 1 Safety Study With Intravitreal (IVT) REGN2176-3 in Patients Aged 50 Years and Older With Wet AMD
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
- 12
- 主要终点
- Safety
研究概览
简要总结
The primary objective of the study is to investigate the safety of intravitreal (IVT) REGN2176-3 in patients with neovascular wet age-related macular degeneration (AMD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Key Criteria:
- •Men or women greater than or equal to 50 years of age who provide informed consent and have active subfoveal choroidal neovascularization (CNV) secondary to wet AMD.
排除标准
- •Any prior treatment with an inhibitor of PDGF (platelet-derived growth factor) or PDGFR (platelet-derived growth factor receptor)
- •Active neovascular AMD in the fellow eye requiring treatment
- •Scar, fibrosis, or atrophy in the study eye involving the center of the fovea
- •Presence of retinal pigment epithelial tears or rips involving the macula in the study eye
- •Prior vitrectomy in the study eye
- •Any history of macular hole of stage 2 and above in the study eye
- •Any intraocular or periocular surgery within 3 months of day 1 in the study eye, except lid surgery
- •History of corneal transplant in the study eye
- •Positive serum human chorionic gonadotropin (hCG)/ urine pregnancy test at the screening or baseline visit
- •The information listed above is not intended to contain all considerations relevant to a patient's potential participation in this clinical trial and not all inclusion/ exclusion criteria are listed.
研究组 & 干预措施
Cohorts 1 - 4
Experimental
Participants in cohort 1 will receive REGN2176-3 dosing regimen 1. Participants in cohort 2 will receive REGN2176-3 dosing regimen 2. Participants in cohort 3 will receive REGN2176-3 dosing regimen 3. Participants in cohort 4 will receive REGN2176-3 dosing regimen 4.
干预措施: REGN2176-3 (Drug)
结局指标
主要结局
Safety
时间窗: day 1 through week 24
The primary endpoint in the study is the incidence of treatment emergent adverse events (TEAEs) from day 1 through week 24 in patients treated with IVT REGN2176-3.
次要结局
未报告次要终点
研究者
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