NCT00607750已完成2 期
A Phase 2 Randomized, Double-Masked, Study to Evaluate the Safety and Preliminary Efficacy of ATG003 in Patients With Neovascular Age-Related Macular Degeneration (NV-AMD) Receiving Frequent Maintenance Intravitreal Anti-VEGF Antibody Therapy (Ranibizumab or Bevacizumab)
CoMentis0 个研究点目标入组 60 人开始时间: 2008年5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
- 60
- 主要终点
- To evaluate the safety of ATG003 (mecamylamine HCL ophthalmic solution)
研究概览
简要总结
This study is a double-masked, randomized, placebo-controlled study of the safety and preliminary efficacy of ATG003 (topical mecamylamine) in patients receiving maintenance injections of either ranibizumab or bevacizumab. Study Hypothesis: Mecamylamine could be effective in the treatment of neovascular AMD.
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
- 56 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 55 years of age
- •clinical diagnosis of neovascular AMD
排除标准
- •confounding ocular condition
研究组 & 干预措施
1
Placebo Comparator
干预措施: Placebo (Drug)
ATG003
Experimental
干预措施: ATG003 (mecamylamine) (Drug)
结局指标
主要结局
To evaluate the safety of ATG003 (mecamylamine HCL ophthalmic solution)
时间窗: Day 1 - Week 50
次要结局
- To evaluate the efficacy of ATG003(Day 1 - Week 50)
研究者
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