Pharmacokinetics of the Brimonidine Tartrate Posterior Segment Delivery System in Patients Undergoing Pars Plana Vitrectomy

Study Identifier
190342-036
CT.gov Identifier
NCT01229410
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 Care - Other
    • Study Drug
  • 400 µg Brimonidine Tartrate Implant
  • 200 µg Brimonidine Tartrate Implant
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Plan on having a pars plana vitrectomy for repair of a posterior segment condition (eg, epiretinal membrane, macular hole, vitreomacular traction) * Visual acuity in the non-study eye better than 20/200
    Exclusion Criteria:
    * History of pars plana vitrectomy or retinal detachment surgery in the study eye * Surgery or laser treatment in the study eye within 3 months * Use of brimonidine, apraclonidine or other topical alpha-2-agonist in either eye within 2 weeks * Intraocular infection or inflammation

    Protocol Summary

    This study will evaluate the pharmacokinetics of brimonidine following a single intravitreal administration of the 200 ug or 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery System in patients 2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy.

    Study Locations

    Location
    Status
    Location
    Salt Lake City, Utah, United States
    Status
    Not applicable
    Location
    Prague, Czech Republic
    Status
    Not applicable