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
• 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
• 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

Related Conditions & MeSH terms

• Inflammation
• Uveitis

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