A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema

Study Identifier
206207-010
CT.gov Identifier
NCT00168389
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Macular Edema
    • Study Drug
  • Dexamethasone
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * 18 years of age or older with diabetic macular edema; * Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse); * Visual acuity in other eye no worse than 20/200
    Exclusion Criteria:
    * Known anticipated need for ocular surgery within first 12 months of study; * History of glaucoma or current high eye pressure requiring more than 1 medication; * Uncontrolled systemic disease; * Known steroid-responder; * Use of systemic steroids * Use of Warfarin/Heparin

    Protocol Summary

    This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of diabetic macular edema.

    Study Locations

    Location
    Status
    Location
    Inglewood, California, United States
    Status
    Not applicable
    Location
    Westmead, New South Wales, Australia
    Status
    Not applicable
    Location
    Toronto, Ontario, Canada
    Status
    Not applicable
    Location
    Prague, Czech Republic
    Status
    Not applicable
    Location
    Hamburg, Germany
    Status
    Not applicable
    Location
    Tel Aviv, Israel
    Status
    Not applicable
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