Safety and Efficacy Study of Ozurdex® Compared to Lucentis® in Patients With Branch Retinal Vein Occlusion

Study Identifier
MAF-AGN-OPH-RET-004
CT.gov Identifier
NCT01427751
EudraCT Identifier
2010-023900-29
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
  • dexamethasone intravitreal implant
  • ranibizumab
    • Phase
    Phase 4
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Diagnosis of branch retinal vein occlusion in at least one eye * Visual acuity between 20/400 to 20/40
    Exclusion Criteria:
    * Active eye infection * Ocular hypertension which is not controlled on monotherapy (one medication) * Anticipated need for eye surgery during the study * Cataract surgery in either eye within 3 months * Eye surgery including laser of any type within 6 months * Anti-VEGF treatment in either eye (eg, Lucentis®) within 3 months or systemic anti-VEGF treatment (eg, Avastin) within 6 months * Use of ocular steroids within 3 months * Use of steroids (except for inhaled or intranasal) within 1 month or anticipated use during the study

    Protocol Summary

    This study will evaluate the safety and efficacy of dexamethasone intravitreal implant (Ozurdex®) compared to ranibizumab (Lucentis®) in patients with branch retinal vein occlusion (BRVO).

    Study Locations

    Location
    Status
    Location
    Paris, France
    Status
    Not applicable
    Location
    Munich, Germany
    Status
    Not applicable
    Location
    Tel Aviv, Israel
    Status
    Not applicable
    Location
    Milan, Italy
    Status
    Not applicable
    Location
    Madrid, Spain
    Status
    Not applicable
    Location
    London, United Kingdom
    Status
    Not applicable