NCT02771340已完成1 期
A Phase 1, Open-label, Multicenter Study Evaluating the Safety and Tolerability, Biologic Activity, Pharmacodynamics, and Pharmacokinetics of Single and Repeated Escalating Intravitreal Doses of ICON-1 in Patients With Uveal Melanoma Who Are Planned to Undergo Enucleation or Brachytherapy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 8
- 主要终点
- Occurrence of Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, biological activity, pharmacokinetics and pharmacodynamic activity of single and repeated escalating intravitreal doses of ICON-1 in patients with primary uveal melanoma who are planned to undergo enucleation or brachytherapy of the affected eye.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females of any race at least 18 years of age
- •Clinical diagnosis of primary uveal melanoma involving the posterior uveal tract in the study eye
- •Planned enucleation or brachytherapy of the study eye due to uveal melanoma
排除标准
- •Uveal melanoma in the study eye originating in the anterior uveal tract (iris)
- •Hereditary or chronic hemorrhagic or coagulopathy conditions (i.e., hemophilia)
- •Woman who is pregnant or lactating
结局指标
主要结局
Occurrence of Adverse Events
时间窗: 30 days (plus or minus 5 days) after surgical procedure
次要结局
- Changes in Plasma Levels of ICON-1.(Baseline to 1 day after last dose of ICON-1)
- Change in Best Corrected Visual Acuity (BCVA) From Baseline to End of Study(Baseline to on or 1 day prior to surgical procedure day)
研究者
研究点 (8)
Loading locations...
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