Safety and Efficacy of a New Treatment in Vitrectomized Subjects With Diabetic Macular Edema

Study Identifier
206207-018
CT.gov Identifier
NCT00799227
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
  • Eye Care - Other
    • Study Drug
  • Dexamethasone
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * 18 years of age or older with diabetic macular edema * History of vitrectomy * Central retinal thickness ≥ 275 µm * Visual acuity between 20/320 and 20/40 in the study eye and no worse than 20/200 in the other eye
    Exclusion Criteria:
    * Known anticipated need for ocular surgery during the study period * History of glaucoma or current high eye pressure requiring more than 1 medication * Uncontrolled systemic disease * Known allergy to the study medication * Known steroid-responder * Use of systemic steroids * Female subjects that are pregnant, nursing or planning a pregnancy

    Protocol Summary

    The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant in the study eye of vitrectomized subjects with diabetic macular edema. Subjects will be followed for 26 weeks.

    Study Locations

    Location
    Status
    Location
    Charlotte, North Carolina, United States
    Status
    Not applicable
    Location
    Sydney, New South Wales, Australia
    Status
    Not applicable