Intravitreal Celecoxib for Chronic Uveitis
关键词
抽象
描述
Specific Aims I: Test the safety of intraocular injection of 1mg and 4mg celecoxib in patients who have chronic inflammation or macular edema who are unable to tolerate corticosteroids due to their side effects.
II: Test the efficacy of intraocular 1mg and 4mg celecoxib in treating inflammation or structural complications of inflammation (macular edema) in patients who are unable to tolerate corticosteroids due to their side effects.
After investigational new drug application and Vanderbilt Institutional Review Board approval, celecoxib will be compounded by the Investigational Drug Service of the Vanderbilt Medical Center and packaged in individual sterile single use syringes for intraocular injection within 2 hours of preparation. Pharmaceutical grade celecoxib will be obtained from the drug manufacturer (Pfizer) with certificate analysis and compounded in sterile dimethyl sulfoxide following strict sterile technique.
日期
| 最后验证: | 01/31/2017 |
| 首次提交: | 04/30/2014 |
| 提交的预估入学人数: | 04/30/2014 |
| 首次发布: | 05/05/2014 |
| 上次提交的更新: | 02/19/2017 |
| 最近更新发布: | 02/22/2017 |
| 实际学习开始日期: | 05/31/2015 |
| 预计主要完成日期: | 10/31/2016 |
| 预计完成日期: | 10/31/2016 |
状况或疾病
干预/治疗
Drug: Celecoxib
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Celecoxib 1-4 mg intravitreal injection ofCelecoxib | Drug: Celecoxib 1-4 mg intravitreal celecoxib |
资格标准
| 有资格学习的年龄 | 15 Years 至 15 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Chronic inflammation and/or macular edema despite maximal medical treatment Unable to tolerate corticosteroids due to side effects Aphakic or Pseudophakic subjects Exclusion Criteria: - 15 years or younger Have active ocular infection Pregnancy Phakic subjects |
结果
主要结果指标
1. Safety [12 weeks]
次要成果指标
1. Efficacy [12 weeks]
