Intravitreal Celecoxib for Chronic Uveitis

Phase 1

Terminated

• Conditions: Inflammation
• Interventions: Drug: Intravitreal Celecoxib

• Registration Number: NCT02131012
• Lead Sponsor: Vanderbilt University

Brief 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.

Study Timeline

• Study First Submitted: 2014-05-01
• Study First Submitted QC: 2014-05-01
• Study First Posted: 2014-05-06
• Study Start: 2015-06
• Primary Completion: 2016-11-01
• Study Completion: 2016-11-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-20
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Celecoxib	Intravitreal Celecoxib	1-4 mg intravitreal injection ofCelecoxib

Primary Outcome Measures

Name	Time	Method
Safety	12 weeks	Participant will receive an intravitreal injection of the Celecoxib and be followed for any possible adverse events

Secondary Outcome Measures

Name	Time	Method
Efficacy	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