Intravitreal Celecoxib for Chronic Uveitis
키워드
요약
기술
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.
날짜
| 마지막 확인: | 01/31/2017 |
| 처음 제출: | 04/30/2014 |
| 제출 된 예상 등록: | 04/30/2014 |
| 처음 게시 됨: | 05/05/2014 |
| 제출 된 마지막 업데이트: | 02/19/2017 |
| 마지막 업데이트 게시: | 02/22/2017 |
| 실제 연구 시작 날짜: | 05/31/2015 |
| 예상 기본 완료 날짜: | 10/31/2016 |
| 예상 연구 완료 날짜: | 10/31/2016 |
상태 또는 질병
개입 / 치료
Drug: Celecoxib
단계
팔 그룹
| 팔 | 개입 / 치료 |
|---|---|
| Experimental: Celecoxib 1-4 mg intravitreal injection ofCelecoxib | Drug: Celecoxib 1-4 mg intravitreal celecoxib |
자격 기준
| 공부할 수있는 연령 | 15 Years 에 15 Years |
| 공부할 수있는 성별 | All |
| 건강한 자원 봉사자를 받아들입니다 | 예 |
| 기준 | 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 |
결과
1 차 결과 측정
1. Safety [12 weeks]
2 차 결과 측정
1. Efficacy [12 weeks]
