Safety and Efficacy of Dexamethasone as Adjunctive Therapy to Ranibizumab in Subjects With Choroidal Neovascularization and Age-Related Macular Degeneration

Study Identifier
206207-021
CT.gov Identifier
NCT01122511
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Details

Medical Condition
  • Eye Disease
  • Macular Degeneration - Other
    • Study Drug
  • 700 ug dexamethasone
  • ranibizumab
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    50+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Received at least 2 and no more than 3 monthly Lucentis or Avastin injections * Last Lucentis or Avastin was injected approximately 4 weeks prior to screening * Visual acuity between 20/320 and 20/40
    Exclusion Criteria:
    * Active ocular infection * Contraindication to pupil dilation in either eye * Eye surgery including cataract surgery and/or laser of any type within 3 months

    Protocol Summary

    This study will evaluate the safety and efficacy of dexamethasone (OZURDEX®) as adjunctive therapy to ranibizumab (LUCENTIS®) compared with ranibizumab alone in the treatment of patients with choroidal neovascularization secondary to age-related macular degeneration

    Study Locations

    Location
    Status
    Location
    Fort Myers, Florida, United States
    Status
    Not applicable
    Location
    Abilene, Texas, United States
    Status
    Not applicable