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Intraviteral Celecoxib for Chronic Uveitis

Information source: Vanderbilt University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Inflammation

Intervention: Intravitreal Celecoxib (Drug)

Phase: Phase 1

Status: Not yet recruiting

Sponsored by: Vanderbilt University

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Safety

Secondary outcome: Efficacy

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 IRB 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.

Eligibility

Minimum age: 15 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Chronic inflammation and/or macular edema despite maximal medical treatment Unable to

tolerate corticosteroids due to side effects Aphakic or Psuedophakic subjects Exclusion Criteria:

- 15 years or younger Have active ocular infection Pregnancy Phakic subjects

Locations and Contacts

Additional Information

Starting date: May 2014
Last updated: May 1, 2014

Page last updated: August 20, 2015

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