Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to Age-related Macular Degeneration (AMD)

Study Identifier
190342-032D
CT.gov Identifier
NCT00658619
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 Degeneration - Other
    • Study Drug
  • 400 µg Brimonidine Tartrate Implant
  • 200 µg Brimonidine Tartrate Implant
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    50+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Geographic atrophy in both eyes due to age-related macular degeneration * Visual acuity between 20/40 to 20/320
    Exclusion Criteria:
    * Known allergy to brimonidine * 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

    Stage 1 is a patient-masked, dose-escalation, safety evaluation of brimonidine intravitreal implant. Patients will receive implant in one eye and "sham" treatment (meaning no treatment) in the fellow eye. Stage 2 will begin after 1 month of safety has been evaluated for Stage 1. Stage 2 is a randomized, double-masked, dose-response, sham-controlled evaluation of the safety and efficacy of brimonidine intravitreal implant in patients with geographic atrophy from age-related macular degeneration. Patients will be followed for up to 2 years.

    Study Locations

    Location
    Status
    Location
    Abilene, Texas, United States
    Status
    Not applicable
    Location
    Sydney, New South Wales, Australia
    Status
    Not applicable
    Location
    Karlsruhe, Germany
    Status
    Not applicable
    Location
    Udine, Italy
    Status
    Not applicable
    Location
    Makati City, Philippines
    Status
    Not applicable
    Location
    Coimbra, Portugal
    Status
    Not applicable
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