Intravitreal Celecoxib for Chronic Uveitis

NCT ID: NCT02131012

Last Updated: 2017-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-11-01

Brief Summary

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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

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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

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Inflammation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Celecoxib

1-4 mg intravitreal injection ofCelecoxib

Group Type EXPERIMENTAL

Intravitreal Celecoxib

Intervention Type DRUG

1-4 mg intravitreal celecoxib

Interventions

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Intravitreal Celecoxib

1-4 mg intravitreal celecoxib

Intervention Type DRUG

Other Intervention Names

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Celebrex NSAIDS

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Stephen J. Kim, MD

Assistant Professor of Ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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IND for Celecoxib

Identifier Type: -

Identifier Source: org_study_id

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