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Intravitreal Celecoxib for Chronic Uveitis (Celecoxib)

Primary Purpose

Inflammation

Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Intravitreal Celecoxib
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammation focused on measuring Macular edema

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Celecoxib

    Arm Description

    1-4 mg intravitreal injection ofCelecoxib

    Outcomes

    Primary Outcome Measures

    Safety
    Participant will receive an intravitreal injection of the Celecoxib and be followed for any possible adverse events

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    May 1, 2014
    Last Updated
    February 20, 2017
    Sponsor
    Vanderbilt University
    Collaborators
    Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02131012
    Brief Title
    Intravitreal Celecoxib for Chronic Uveitis
    Acronym
    Celecoxib
    Official Title
    Intravitreal Celecoxib for Chronic Uveitis: A Phase I Investigational Safety Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Terminated
    Why Stopped
    Difficulty recruiting
    Study Start Date
    June 2015 (Actual)
    Primary Completion Date
    November 1, 2016 (Actual)
    Study Completion Date
    November 1, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Vanderbilt University
    Collaborators
    Pfizer

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Inflammation
    Keywords
    Macular edema

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    4 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Celecoxib
    Arm Type
    Experimental
    Arm Description
    1-4 mg intravitreal injection ofCelecoxib
    Intervention Type
    Drug
    Intervention Name(s)
    Intravitreal Celecoxib
    Other Intervention Name(s)
    Celebrex, NSAIDS
    Intervention Description
    1-4 mg intravitreal celecoxib
    Primary Outcome Measure Information:
    Title
    Safety
    Description
    Participant will receive an intravitreal injection of the Celecoxib and be followed for any possible adverse events
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Efficacy
    Description
    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
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

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