NCT01301443已完成1 期
A Phase I Dose Escalation Safety Study of Subretinally Injected RetinoStat, a Lentiviral Vector Expressing Endostatin and Angiostatin, in Patients With Advanced Neovascular Age-Related Macular Degeneration
Oxford BioMedica3 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2011年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 3
- 主要终点
- The incidence of adverse events
研究概览
简要总结
The purpose of this first in man study is to examine the safety of an experimental gene transfer agent, RetinoStat, designed to treat neovascular age-related macular degeneration.
详细描述
There are two parts to the study. A dose-escalation phase looking at three doses of RetinoStat starting with the lowest dose, three patients will be recruited at each dose level. The escalation phase will be followed by a dose confirmation phase where the highest dose that is safe and well tolerated will be examined in 9 patients.
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
- •Clinical diagnosis of AMD with active CNV that shows evidence of leakage.
- •BCVA less than or equal to 20/200 in the study eye for dose escalation phase.
- •BCVA less than or equal to 20/80 in the study eye for maximum tolerated dose phase.
排除标准
- •Significant ocular abnormalities that prevent retinal assessment.
- •Treatment with steroids within three months of screening.
- •Treatment with anti-VEGF therapy to either eye within one month of screening.
- •Clinically significant intercurrent illnesses, laboratory, ECG or chest XRay abnormalities.
研究组 & 干预措施
Subretinally Injected RetinoStat
Experimental
Subretinally injected RetinoStat
干预措施: Subretinally injected RetinoStat (Drug)
结局指标
主要结局
The incidence of adverse events
时间窗: 24 weeks
The number and percentage of patients with treatment emergent adverse events.
次要结局
- Change from baseline in subretinal and intraretinal fluid as measured by OCT(24 weeks)
研究者
研究点 (3)
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