An Exploratory Study to Evaluate the Safety of Brimonidine Intravitreal Implant in Patients With Retinitis Pigmentosa

Study Identifier
190342-028D
CT.gov Identifier
NCT00661479
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
  • Eye Disease
    • Study Drug
  • 400 µg Brimonidine Tartrate Implant
  • 200 µg Brimonidine Tartrate Implant
  • 100 µg Brimonidine Tartrate Implant
    • Phase
    Phase 1/Phase 2
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Retinitis Pigmentosa in both eyes * Visual acuity between 20/40 to count fingers
    Exclusion Criteria:
    * Growth of new blood vessels in the eye * Any intraocular surgery or laser in either eye in the last 6 months prior to Screening visit or between the Screening visit and Day 1 * Any ocular disease that can interfere with diagnosis and or assessment of disease progression * Significant near-sightedness * HIV * Female patients who are pregnant, nursing, or planning pregnancy

    Protocol Summary

    This exploratory, 12-month, ascending-dose study will evaluate the safety and effects on visual function of a single injection of Brimonidine intravitreal implant in one eye of patients with Retinitis Pigmentosa.

    Study Locations

    Location
    Status
    Location
    Arlington, Texas, United States
    Status
    Not applicable
    Location
    Paris, France
    Status
    Not applicable
    Location
    Tübingen, Germany
    Status
    Not applicable
    Location
    Coimbra, Portugal
    Status
    Not applicable