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A Study of Denufosol Tetrasodium Intravitreal Injection in Subjects With Post Cataract Extraction Macular Edema

Primary Purpose

Macular Edema, Cystoid

Status
Withdrawn
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 Macular Edema, Cystoid focused on measuring macular edema, post cataract extraction, cystoid macular edema, post cataract extraction macular edema

Eligibility Criteria

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

Inclusion Criteria: Have persistent post cataract extraction macular edema whose condition is stable Have no change in medication regimen of immunosuppressive or anti-inflammatory agents; steroidal or non-steroidal agents for a specified period of time prior to randomization Have at least one eligible eye to be treated in the study Have an optical coherence tomography (OCT) scan with a qualifying retinal thickness in the study eye Have macular edema confirmed by fluorescein angiography Exclusion Criteria: Have proliferative vitreoretinopathy greater than grade B in either eye Have ocular disorders in the study eye that may confound interpretation of study results Have ophthalmic disorders in the study eye that may influence final visual acuity and/or fluorescein angiography interpretation Have had cataract surgery in the study eye in the past 2 months, YAG laser capsulotomy within the past 1 month, or any other intraocular surgery within the past 90 days Have uncontrollable elevated intraocular pressure (IOP) or advanced glaucoma Have had any periocular or intravitreal injection of corticosteroids in the study eye within 3 months Have had any ocular implant device for the delivery of therapeutic agents Be taking any excluded medications that could obscure or confound study results

Sites / Locations

    Outcomes

    Primary Outcome Measures

    safety
    tolerability
    retinal thickness
    visual acuity

    Secondary Outcome Measures

    Full Information

    First Posted
    August 24, 2005
    Last Updated
    May 20, 2013
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00135655
    Brief Title
    A Study of Denufosol Tetrasodium Intravitreal Injection in Subjects With Post Cataract Extraction 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 Post Cataract Extraction Macular Edema
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2013
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    August 2005 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to investigate the safety and tolerability of three dose strengths of the study drug in subjects with post cataract extraction macular edema.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Macular Edema, Cystoid
    Keywords
    macular edema, post cataract extraction, cystoid macular edema, post cataract extraction macular edema

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    denufosol tetrasodium (INS37217) Intravitreal Injection
    Primary Outcome Measure Information:
    Title
    safety
    Title
    tolerability
    Title
    retinal thickness
    Title
    visual acuity

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Have persistent post cataract extraction macular edema whose condition is stable Have no change in medication regimen of immunosuppressive or anti-inflammatory agents; steroidal or non-steroidal agents for a specified period of time prior to randomization Have at least one eligible eye to be treated in the study Have an optical coherence tomography (OCT) scan with a qualifying retinal thickness in the study eye Have macular edema confirmed by fluorescein angiography Exclusion Criteria: Have proliferative vitreoretinopathy greater than grade B in either eye Have ocular disorders in the study eye that may confound interpretation of study results Have ophthalmic disorders in the study eye that may influence final visual acuity and/or fluorescein angiography interpretation Have had cataract surgery in the study eye in the past 2 months, YAG laser capsulotomy within the past 1 month, or any other intraocular surgery within the past 90 days Have uncontrollable elevated intraocular pressure (IOP) or advanced glaucoma Have had any periocular or intravitreal injection of corticosteroids in the study eye within 3 months Have had any ocular implant device for the delivery of therapeutic agents 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
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    A Study of Denufosol Tetrasodium Intravitreal Injection in Subjects With Post Cataract Extraction Macular Edema

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