Study Results
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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TERMINATED
PHASE1
4 participants
INTERVENTIONAL
2015-06-30
2016-11-01
Brief Summary
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Detailed Description
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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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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Celecoxib
1-4 mg intravitreal injection ofCelecoxib
Intravitreal Celecoxib
1-4 mg intravitreal celecoxib
Interventions
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Intravitreal Celecoxib
1-4 mg intravitreal celecoxib
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
15 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Vanderbilt University
OTHER
Responsible Party
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Stephen J. Kim, MD
Assistant Professor of Ophthalmology
Other Identifiers
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IND for Celecoxib
Identifier Type: -
Identifier Source: org_study_id
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