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Study to Treat Uveitis Associated Macular Edema

Primary Purpose

Cystoid Macular Edema, Uveitis

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
denufosol tetrasodium (INS37217) Intravitreal Injection
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystoid Macular Edema focused on measuring uveitis, macular edema, uveitis associated macular edema

Eligibility Criteria

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

Inclusion Criteria: Have anterior uveitis, intermediate uveitis, posterior uveitis or panuveitis in at least one eye Have persistent macular edema and uveitis whose conditions are stable Have no change in medication regimen for at least 3 months prior to randomization if currently taking medications such as immunosuppressive or anti-inflammatory agents; steroidal or non-steroidal agents (drops, oral or injected) Have an OCT scan with a qualifying retinal thickness in the study eye Have evidence of macular edema on OCT scan Have at lease one eligible eye to be treated in the study based on visual acuity. Exclusion Criteria: Have proliferative vitreoretinopathy greater than grade B Have subretinal or vitreous hemorrhage, corneal opacity, or other conditions, which limit the view of the retina or obscure FA Have uncontrollable elevated IOP, advanced, previous filtration surgery, or any current evidence of endophthalmitis in the study eye Have ocular disorders in the study eye that may confound interpretation of study results Have had cataract surgery in the study eye within 3 months, YAG laser capsulotomy within the past 1 month, or any other intraocular surgery within the past 90 days Have pre-operative spherical equivalent refractive error of more than -10 diopters of myopia in the study eye Have had any intravitreal or periocular injection or corticosteroids in the study eye during the 3 months prior to screening Have any ocular implant device for the delivery of therapeutic agents to the eye Be taking any excluded medications that could obscure or confound study results

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Evaluate the safety and tolerability of denufosol in subjects presenting with uveitis associated macular edema.
    Assess the utility of denufosol in treating uveitis associated macular edema.

    Secondary Outcome Measures

    Pilot study - not specified

    Full Information

    First Posted
    June 13, 2005
    Last Updated
    November 28, 2016
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00114062
    Brief Title
    Study to Treat Uveitis Associated Macular Edema
    Official Title
    A Randomized, Double-Masked, Parallel Group, Multi-Center, Dose Ranging Pilot Study of Denufosol Tetrasodium (INS37217) Intravitreal Injection in Subjects With Uveitis Associated Macular Edema
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Terminated
    Study Start Date
    September 2005 (undefined)
    Primary Completion Date
    December 2006 (Actual)
    Study Completion Date
    December 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether denufosol tetrasodium (INS37217) Intravitreal Injection is well tolerated and has the potential to treat uveitis associated macular edema.
    Detailed Description
    Denufosol tetrasodium (INS37217) Intravitreal Injection may provide clinical benefit in treatment of uveitis associated macular edema (UME) by reducing retinal thickness as measured by OCT and possibly enabling recovery of vision loss associated with UME. Denufosol tetrasodium may also reverse the fluid accumulation of UME.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cystoid Macular Edema, Uveitis
    Keywords
    uveitis, macular edema, uveitis associated macular edema

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    15 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    denufosol tetrasodium (INS37217) Intravitreal Injection
    Primary Outcome Measure Information:
    Title
    Evaluate the safety and tolerability of denufosol in subjects presenting with uveitis associated macular edema.
    Title
    Assess the utility of denufosol in treating uveitis associated macular edema.
    Secondary Outcome Measure Information:
    Title
    Pilot study - not specified

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Have anterior uveitis, intermediate uveitis, posterior uveitis or panuveitis in at least one eye Have persistent macular edema and uveitis whose conditions are stable Have no change in medication regimen for at least 3 months prior to randomization if currently taking medications such as immunosuppressive or anti-inflammatory agents; steroidal or non-steroidal agents (drops, oral or injected) Have an OCT scan with a qualifying retinal thickness in the study eye Have evidence of macular edema on OCT scan Have at lease one eligible eye to be treated in the study based on visual acuity. Exclusion Criteria: Have proliferative vitreoretinopathy greater than grade B Have subretinal or vitreous hemorrhage, corneal opacity, or other conditions, which limit the view of the retina or obscure FA Have uncontrollable elevated IOP, advanced, previous filtration surgery, or any current evidence of endophthalmitis in the study eye Have ocular disorders in the study eye that may confound interpretation of study results Have had cataract surgery in the study eye within 3 months, YAG laser capsulotomy within the past 1 month, or any other intraocular surgery within the past 90 days Have pre-operative spherical equivalent refractive error of more than -10 diopters of myopia in the study eye Have had any intravitreal or periocular injection or corticosteroids in the study eye during the 3 months prior to screening Have any ocular implant device for the delivery of therapeutic agents to the eye Be taking any excluded medications that could obscure or confound study results
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Amy Schaberg, BSN
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Study to Treat Uveitis Associated Macular Edema

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