Safety and Efficacy of AGN208397 in the Treatment of Macular Edema Associated With Retinal Vein Occlusion (RVO)

Study Identifier
208397-001
CT.gov Identifier
NCT01027650
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 Edema
    • Study Drug
  • AGN208397 intravitreal injection
  • dexamethasone intravitreal implant
    • Phase
    Phase 1/Phase 2
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * macular edema due to retinal vein occlusion * visual acuity in the study eye between 20/320 to 20/40
    Exclusion Criteria:
    * cataract surgery or Lasik within 3 months prior to study Day 1 or anticipated need for cataract surgery during study period (12 months) * use of injectable drugs in the study eye within 2 months prior to day 1 * active eye infection in either eye * visual acuity in the non-study eye of 20/200 or worse

    Protocol Summary

    This study will evaluate the safety and efficacy of a single intravitreal injection of AGN208397 to treat Macular Edema associated with Retinal Vein Occlusion. This study is being conducted in two stages: Stage 1 will enroll approximately 21 subjects who will receive a single open label intravitreal injection of either 75 ug, 300 ug, 600 ug or 900 ug of AGN208397 and be followed for 12 months post treatment; based on Stage 1 results, Stage 2 will enroll approximately 96 subjects who will receive a single masked intravitreal injection of one of three doses of AGN208397 or Ozurdex® and be followed for 12 months post treatment.

    Study Locations

    Location
    Status
    Location
    Phoenix, Arizona, United States
    Status
    Not applicable
    Location
    East Melbourne, Victoria, Australia
    Status
    Not applicable
    Location
    London, Ontario, Canada
    Status
    Not applicable
    Location
    Tel Aviv, Israel
    Status
    Not applicable
    Location
    Cape Town, South Africa
    Status
    Not applicable