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Intravitreal Celecoxib for Chronic Uveitis (Celecoxib)

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ClinicalTrials.gov Identifier: NCT02131012
Recruitment Status : Terminated (Difficulty recruiting)
First Posted : May 6, 2014
Last Update Posted : February 23, 2017
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Stephen J. Kim, MD, Vanderbilt University

Brief 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.

Condition or disease Intervention/treatment Phase
Inflammation Drug: Intravitreal Celecoxib Phase 1

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 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravitreal Celecoxib for Chronic Uveitis: A Phase I Investigational Safety Study
Actual Study Start Date : June 2015
Actual Primary Completion Date : November 1, 2016
Actual Study Completion Date : November 1, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib

Arm Intervention/treatment
Experimental: Celecoxib
1-4 mg intravitreal injection ofCelecoxib
Drug: Intravitreal Celecoxib
1-4 mg intravitreal celecoxib
Other Names:
  • Celebrex
  • NSAIDS




Primary Outcome Measures :
  1. Safety [ Time Frame: 12 weeks ]
    Participant will receive an intravitreal injection of the Celecoxib and be followed for any possible adverse events


Secondary Outcome Measures :
  1. Efficacy [ Time Frame: 12 weeks ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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Responsible Party: Stephen J. Kim, MD, Assistant Professor of Ophthalmology, Vanderbilt University
ClinicalTrials.gov Identifier: NCT02131012     History of Changes
Other Study ID Numbers: IND for Celecoxib
First Posted: May 6, 2014    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Keywords provided by Stephen J. Kim, MD, Vanderbilt University:
Macular edema
Additional relevant MeSH terms:
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Celecoxib
Uveitis
Inflammation
Pathologic Processes
Uveal Diseases
Eye Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action