NCT01941082已完成1 期
A Multiple-Center, Non-Randomized, Open-Label, Single- and Multiple-Ascending-Dose, Parallel Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO6867461 Following Intravitreal Administration in Patients With Wet 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
- 24
- 主要终点
- Safety: Incidence of adverse events
研究概览
简要总结
This multicenter, non-randomized, open-label, single- and multiple-ascending-dose study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO6867461 in patients with wet age-related macular degeneration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Adult patients, >/= 50 years of age
- •Patients with age-related macular degeneration (AMD)
- •Best corrected visual acuity (BCVA) of 20/40 to 20/400 (Snellen equivalent, on ETDRA charts) inclusive
- •Evidence of leakage due to choroidal neovascularization (CNV)
排除标准
- •Choroidal neovascularization (CNV) in either eye due to causes other than age related macular degeneration, such as ocular histoplasmosis, trauma, or pathologic myopia
- •Known hypersensitivity to ranibizumab, fluorescein, indocyanin green (ICG) or any of the ingredients of the formulation used, or any of the medications used
- •Any other restriction according to the use of ranibizumab
- •Active intraocular inflammation (grade trace or above) in the study eye
- •Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
研究组 & 干预措施
Part A: RO6867461
Experimental
Single doses
干预措施: RO6867461 (Drug)
Part B: RO6867461
Experimental
Multiple doses
干预措施: RO6867461 (Drug)
结局指标
主要结局
Safety: Incidence of adverse events
时间窗: Part A, 12 weeks; Part B, 20 weeks
Ocular safety, assessed by BCVA (EDTRS chart), slitlamp examination, ophthalmoscopy, IOP, fundus photography, SD-OCT, angiography
时间窗: Part A, 12 weeks; Part B, 20 weeks
次要结局
- Pharmacokinetics: Area under the concentration time curve (AUC)(Part A, 12 weeks; Part B, 20 weeks)
- Pharmacokinetics: Maximum plasma concentration (Cmax)(Part A, 12 weeks; Part B, 20 weeks)
研究者
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