NCT00503022已完成1 期
A Randomized, Double-Masked, Multi-Center Phase I Study of 6 Months Duration to Assess the Safety and Tolerability of Intravenous ACZ885 in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 20
- 试验地点
- 8
- 主要终点
- Rates of adverse events and serious adverse events, as well as changes in ophthalmic evaluations, laboratory values, electrocardiograms (ECGs) and vital signs over 6 months, following single intravenous infusion of ACZ885.
研究概览
简要总结
This study evaluates the tolerability and safety of a single intravenous infusion of ACZ885. It also explores the efficacy of the compound in central macular edema and visual acuity in patients with wet age-related macular edema.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
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
- •Male or female ≥ 50 years old, with aged related macular degeneration
- •Patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration
排除标准
- •Active intraocular inflammation or ocular infection in the study eye
- •Eye disease that may result in visual loss during the study
- •Chronic therapy with topical, local or systemic corticosteroids.
- •Pregnant or nursing (lactating) women.
结局指标
主要结局
Rates of adverse events and serious adverse events, as well as changes in ophthalmic evaluations, laboratory values, electrocardiograms (ECGs) and vital signs over 6 months, following single intravenous infusion of ACZ885.
次要结局
- Changes in central macular edema from Baseline up to Month 6 Changes in best-corrected visual acuity from Baseline up to Month 6
研究者
研究点 (8)
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