A Dose Escalation Trial of an Intravitreal Injection of Sirna-027 in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)

Study Identifier
SIRNA 0401
CT.gov Identifier
NCT00363714
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 Degeneration - Other
  • Eye Disease
    • Study Drug
  • AGN211745
    • Phase
    Phase 1/Phase 2
    Sex
    Female & Male
    Age
    50+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Active AMD with Subfoveal CNV (classic and/or occult CNV) * CNV lesion thickness \>/= 250um by OCT assessment * Visual acuity in study eye of \
    Exclusion Criteria:
    * Females of childbearing potential * Other causes of CNV including pathologic myopia, the ocular histoplasmosis syndrome, angioid streaks, choroidal rupture and multifocal choroiditis * Any intraocular surgery or treatment of AMD with Visudyne within 3 months of study entry * CNV lesion \>/= 12 MPS disc area

    Protocol Summary

    The purpose of this study will be to assess the safety and tolerability and dose-limiting toxicity of a single intravitreal injection of Sirna-027 (AGN211745) and to assess the anatomical changes in the retina, changes in CNV, and changes in visual acuity. Escalation to the next dose cohort will be completed following minimum of 2 weeks follow-up. Patients will be monitored intensively for three months, and then followed-up for safety up to 24 months post-injection.

    Study Locations

    Location
    Status
    Location
    Baltimore, Maryland, United States
    Status
    Not applicable
    Location
    Cleveland, Ohio, United States
    Status
    Not applicable