Safety and Efficacy Study of Dexamethasone Versus Ranibizumab in Patients With Diabetic Macular Edema

Study Identifier
206207-024
CT.gov Identifier
NCT01492400
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 Intravitreal Implant
  • ranibizumab
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Diagnosis of type 1 or 2 diabetes mellitus * Diagnosis of macular edema * Visual acuity between 20/200 to 20/40
    Exclusion Criteria:
    * Eye surgery to the study eye within 3 months * Use of Ozurdex® within 9 months * Any active ocular inflammation and infection * Diagnosis of glaucoma * Use of anti-VEGF treatment (e.g., Lucentis®) within 3 months in the eye or systemic use (e.g., Avastin®) within 6 months

    Protocol Summary

    This study will compare the safety and efficacy of the 700 ug dexamethasone intravitreal implant with ranibizumab 0.5 mg intravitreal injections in patients with diabetic macular edema (DME).

    Study Locations

    Location
    Status
    Location
    Arlington, Texas, United States
    Status
    Not applicable
    Location
    Brussels, Belgium
    Status
    Not applicable
    Location
    Copenhagen, Denmark
    Status
    Not applicable
    Location
    Glostrup Municipality, Denmark
    Status
    Not applicable
    Location
    Paris, France
    Status
    Not applicable
    Location
    Ahaus, Germany
    Status
    Not applicable
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