NCT00333814已完成2 期
A Study of the Safety and Efficacy of a New Treatment for Non-Infectious Intermediate or Posterior Uveitis
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
- Allergan
- 入组人数
- 229
- 主要终点
- Percentage of Patients With Vitreous Haze (Ocular Inflammation) Score of Zero
研究概览
简要总结
This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of non-infectious intermediate or posterior uveitis.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older with a diagnosis of chronic intermediate uveitis in at least one eye
排除标准
- •Uncontrolled systemic disease
- •Any active ocular infections
研究组 & 干预措施
1
Active Comparator
Dexamethasone 350 µg
干预措施: dexamethasone (Drug)
2
Active Comparator
Dexamethasone 700 µg
干预措施: dexamethasone (Drug)
3
Sham Comparator
Sham
干预措施: Sham injection (Drug)
结局指标
主要结局
Percentage of Patients With Vitreous Haze (Ocular Inflammation) Score of Zero
时间窗: Week 8
Percentage of patients with Vitreous Haze Score of Zero at Week 8. Score is based on standardized scale of 0 to +4 where 0 equals no inflammation and +4 equals optic nerve head not visible (severe).
次要结局
未报告次要终点
研究者
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