Safety and Efficacy of Brimonidine Tartrate Posterior Segment Drug Delivery System in Improving Visual Function

Study Identifier
190342-031D
CT.gov Identifier
NCT00972374
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 ug Brimonidine Implant
  • 200 ug Brimonidine Implant
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * The macula-off retinal detachment must have been caused by a rupture (rhegmatogenous in etiology) * The repair of the macula-off retinal detachment must have occurred at least 6 months before the Day 1 visit in the study eye * The repair must have been deemed an anatomic success and required no more than one macular re-attachment procedure * The visual acuity score must be between 20/50 and 20/320 in the study eye
    Exclusion Criteria:
    * Any sight-threatening ocular condition in the study eye other than the ruptured retinal detachment * Anticipated need for ocular surgery during the 12-month study period * Any injectable, periocular, or intravitreal corticosteroid treatment to study eye within 6 months prior to screening (eg, triamcinolone acetonide) * Any injectable, periocular, or intravitreal anti-VEGF treatment to the study eye within 3 months prior to screening (eg, Avastin or Lucentis) * Any infectious condition in the study eye

    Protocol Summary

    This study will evaluate the efficacy and safety of the Brimo PS DDS® Applicator System (200 μg and 400 μg brimonidine tartrate) on visual function in patients with previous rhegmatogenous macula-off retinal detachment.

    Study Locations

    Location
    Status
    Location
    Abilene, Texas, United States
    Status
    Not applicable
    Location
    New Delhi, India
    Status
    Not applicable
    Location
    Tel Aviv, Israel
    Status
    Not applicable
    Location
    Makati, Philippines
    Status
    Not applicable
    Location
    Seoul, Republic of Korea
    Status
    Not applicable
    Location
    London, United Kingdom
    Status
    Not applicable