Pivotal 1 Study of ABBV-RGX-314 (Also Known as RGX-314) Gene Therapy Administered Via Subretinal Delivery One Time in Participants With nAMD

Study Identifier
RGX-314-2104
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Details

Medical Condition
  • Macular Degeneration - Other
  • Macular Degeneration - Wet Age-Related Macular Degeneration (wAMD)
  • Eye Disease
  • Study Drug
  • Ranibizumab (LUCENTIS®)
  • Phase
    Phase 2/Phase 3
    Sex
    Female & Male
    Age
    50 - 89 Years

    Protocol Summary

    ABBV-RGX-314 (also known as RGX-314) is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD or nAMD). Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina. Wet AMD is a significant cause of vision loss in the United States, Europe and Japan, with up to 2 million people living with wet AMD in these geographies alone. Current anti-vascular endothelial growth factor (anti-VEGF) therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to maintain or prevent progression of vision loss in the majority of patients. These therapies, however, require life-long intraocular injections, typically repeated every 4 to 16 weeks in frequency, to maintain efficacy. Due to the burden of these treatments, patients often experience a decline in vision with reduced frequency of treatment over time.

    Study Locations

    Location
    Status
    Location
    Retinal Research Institute /ID# 256019
    Phoenix, Arizona, United States, 85053
    Status
    Not applicable
    Location
    Barnet Dulaney Perkins Eye Center - Sun City /ID# 256055
    Sun City, Arizona, United States, 85351
    Status
    Not applicable
    Location
    University of Arkansas for Medical Sciences /ID# 271290
    Little Rock, Arkansas, United States, 72205
    Status
    Not applicable
    Location
    Retina Vitreous Assoc Med Grp /ID# 256299
    Beverly Hills, California, United States, 90211
    Status
    Not applicable
    Location
    Retinal Diagnostic Center /ID# 256137
    Campbell, California, United States, 95008
    Status
    Not applicable
    Location
    The Retina Partners - Encino /ID# 256054
    Encino, California, United States, 91436
    Status
    Not applicable
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