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NCT02131012 Clinical Trial

Intravitreal Celecoxib for Chronic Uveitis

Inflammation Clinical Trial

— Celecoxib  

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02131012
Other study ID # IND for Celecoxib
Secondary ID
Status Terminated
Phase Phase 1
First received May 1, 2014
Last updated February 20, 2017
Start date June 2015
Est. completion date November 1, 2016

Study information
Verified date February 2017
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 4
Est. completion date November 1, 2016
Est. primary completion date November 1, 2016
Accepts healthy volunteers No
Gender All
Age group 15 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Intravitreal Celecoxib
1-4 mg intravitreal celecoxib

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Vanderbilt University Pfizer

Outcome
Type Measure Description Time frame Safety issue
Primary Safety Participant will receive an intravitreal injection of the Celecoxib and be followed for any possible adverse events 12 weeks
Secondary Efficacy 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 12 weeks
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