Intravitreal Ketorolac for Chronic Uveitis:A Phase I Investigational Safety Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
Intraocular delivery of ketorolac will be an effective means to treat inflammation and macular edema and prevent structural complications and vision loss in patients with uveitis who are unable to tolerate corticosteroids due to their side effects.
详细描述
A Phase I safety study of intravitreal ketorolac in patients with chronic inflammation and complications due to inflammation who have either failed medical therapy or who cannot tolerate corticosteroids due to side effects.
Specific Aims
- Test the safety of intraocular injection of 4mg of ketorolac in patients who have intractable uveitis or complications of uveitis such as chronic macular edema who are unable to tolerate corticosteroids due to their side effects.
- Test the efficacy of intraocular 4m ketorolac of treating inflammation or structural complications of inflammation in patients with uveitis who are unable to tolerate corticosteroids due to their side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult volunteers
- •Chronic intractable uveitis or chronic complications of uveitis (macular edema)despite maximal medical treatment
- •Unable to tolerate corticosteroids due to side effects
排除标准
- •18 years or younger
- •Have active ocular infection
- •Pregnancy
研究组 & 干预措施
Ketorolac
4mg intravitreal injection of ketorolac
干预措施: Intravitreal Ketorolac (Drug)
结局指标
主要结局
Safety
时间窗: 90 days
Baseline and 90 day electroretinogram and goldmann visual fields will be compared to assess for retinal toxicity.
次要结局
未报告次要终点
研究者
Stephen J. Kim, MD
Principal Investigator
Vanderbilt University