Intravitreal Celecoxib for Chronic Uveitis (Celecoxib)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02131012|
Recruitment Status : Terminated (Difficulty recruiting)
First Posted : May 6, 2014
Last Update Posted : February 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Inflammation||Drug: Intravitreal Celecoxib||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intravitreal Celecoxib for Chronic Uveitis: A Phase I Investigational Safety Study|
|Actual Study Start Date :||June 2015|
|Actual Primary Completion Date :||November 1, 2016|
|Actual Study Completion Date :||November 1, 2016|
1-4 mg intravitreal injection ofCelecoxib
Drug: Intravitreal Celecoxib
1-4 mg intravitreal celecoxib
- Safety [ Time Frame: 12 weeks ]Participant will receive an intravitreal injection of the Celecoxib and be followed for any possible adverse events
- Efficacy [ Time Frame: 12 weeks ]Participant will receive the intravitreal injection of celecoxib day 1 and be followed for efficacy. The efficacy will be determined from the ophthalmic exams and aqueous samples