Safety and Efficacy of a New Therapy as Adjunctive Therapy to Anti-vascular Endothelial Growth Factor (Anti-VEGF) in Subjects With Wet Age-Related Macular Degeneration (AMD)

Study Identifier
206207-019
CT.gov Identifier
NCT00775411
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
  • Macular Degeneration - Other
    • Study Drug
  • dexamethasone
  • ranibizumab
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    50+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * 50 years of age or older with active subfoveal choroidal neovascularization (CNV) secondary to AMD * Central retinal thickness ≥ 300 µm * Visual acuity between 20/400 and 20/32 * Eligible for Anti-VEGF therapy
    Exclusion Criteria:
    * Previous treatment for CNV due to AMD * High eye pressure * Glaucoma * Uncontrolled systemic disease * Known allergy to the study medications * Recent eye surgery or injections in the eye * Female subjects that are of childbearing potential

    Protocol Summary

    The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant as adjunctive therapy to Anti-VEGF treatment in the study eye of treatment naïve subjects with choroidal neovascularization secondary to age-related macular degeneration. Subjects will be followed for 26 weeks.

    Study Locations

    Location
    Status
    Location
    San Antonio, Texas, United States
    Status
    Not applicable
    Location
    Sydney, New South Wales, Australia
    Status
    Not applicable
    Location
    Manila, Philippines
    Status
    Not applicable