NCT02131012

Intravitreal Celecoxib for Chronic Uveitis

Intravitreal Celecoxib for Chronic Uveitis: A Phase I Investigational Safety Study

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

Intraocular delivery of celecoxib will be an effective means to treat inflammation and macular edema and prevent structural complications and vision loss in patients with chronic inflammation or macular edema who are unable to tolerate corticosteroids due to their side effects.

Detailed description

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.

Conditions

• Inflammation

Interventions

Type	Name	Description
DRUG	Intravitreal Celecoxib	1-4 mg intravitreal celecoxib

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2014-05-06
• Last updated: 2017-02-23