NCT01023295已完成2 期
OXiGENE OXC402-201: A Phase 2, Randomized, Double-Masked, Placebo-Controlled Study of the Safety, Pharmacokinetics, and Biological Effects of Intravenous Fosbretabulin in Asian Subjects With Polypoidal Choroidal Vasculopathy (PCV)
Mateon Therapeutics1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2009年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Evaluate change in number of polypoid lesions on ICGA from baseline to Day 2
研究概览
简要总结
The primary objective of this study is to examine effects of fosbretabulin tromethamine (fosbretabulin) on PCV as reflected by a change from baseline in the number of polypoid lesions on indocyanine green angiography (ICGA).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Placebo Comparator
single dose
干预措施: Saline (Drug)
15 mg/m^2
Experimental
15 mg/m^2 fosbretabulin, single dose
干预措施: fosbretabulin (Drug)
25 mg/m^2
Experimental
25 mg/m^2 fosbretabulin, single dose
干预措施: fosbretabulin (Drug)
35 mg/m^2
Experimental
35 mg/m^2 fosbretabulin, single dose
干预措施: fosbretabulin (Drug)
45 mg/m^2
Experimental
45 mg/m^2 fosbretabulin, single dose
干预措施: fosbretabulin (Drug)
结局指标
主要结局
Evaluate change in number of polypoid lesions on ICGA from baseline to Day 2
时间窗: from baseline to Day 2
Evaluate change in the number of polypoid lesions on ICGA from baseline to Day 8
时间窗: from baseline to Day 8
次要结局
- Evaluate the change in area of the branching vascular network of PCV using ICGA from baseline to Day 2(baseline to Day 2)
- Evaluate the change in the area of branching vascular network of PCV on ICGA from baseline to Day 8(baseline to Day 8)
- Examine effects of fosbretabulin on choroidal neovasculariztion (CNV) and total lesion size using fluorescein angiography (FA)(Day 29)
研究者
研究点 (1)
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