Safety and Effects of Brimonidine Intravitreal Implant in Patients With Glaucomatous Optic Neuropathy

Study Identifier
190342-030D
CT.gov Identifier
NCT00693485
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
  • Glaucoma - Open Angle
    • Study Drug
  • 400 ug Brimonidine Implant
  • 200 ug Brimonidine Implant
  • Sham (no implant)
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Primary open-angle glaucoma in one eye * Visual acuity 20/80 or better * Intraocular pressure in the study eye ≤ 24 mm Hg * Glaucomatous visual field loss - 7 dB to - 25 dB
    Exclusion Criteria:
    * Known allergy to brimonidine tartrate * Uncontrolled systemic disease or infection of the eye * Recent eye surgery or injections in the eye * Female patients who are pregnant, nursing or planning a pregnancy

    Protocol Summary

    A multicenter, randomized, patient-masked, sham-controlled evaluation of the safety and effects on visual function of brimonidine intravitreal implant in patients with glaucomatous optic neuropathy. Patients will be followed for up to 1 year.

    Study Locations

    Location
    Status
    Location
    Artesia, California, United States
    Status
    Not applicable
    Location
    Tel Aviv, Israel
    Status
    Not applicable