NCT00541333暂停1 期
Weekly Vaccination With Copaxone as a Potential Therapy for Dry Age-related Macular Degeneration
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Total drusen area reduction
研究概览
简要总结
The purpose of the project is to investigate in eyes with dry AMD, the efficacy and safety as preventive therapy of the immunomodulatory substance named copaxone which had been proven as safe and effective agent for a neurodegenerative disease, in arresting the progression as well as the conversion of dry AMD to wet AMD. The hypothesis that the immunomodulatory agent copaxone proven for a neurodegenerative disease may work in the eye is revolutionary and may open a new avenue of preventive treatment for the disease which is the major cause of legal blindness in the industrial world
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 (Participant, Outcomes Assessor)
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
- •Dry AMD in one or both eyes
- •Age 50 or above of either gender
- •Signed informed consent.
排除标准
- •Known sensitivity to Mannitol or Copaxone.
- •Skin disease or active infection of skin.
- •Active fever or active treatment for infection.
- •History of other uncontrolled systemic active disease.
- •Premenopausal females not using reliable birth control.
- •Sensitivity to fluorescein or iodine.
- •Inability to comply with study procedures.
研究组 & 干预措施
Copaxone
Active Comparator
干预措施: Copaxone Injection (Drug)
Sham
Sham Comparator
干预措施: Copaxone Injection (Drug)
结局指标
主要结局
Total drusen area reduction
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (1)
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