RGX-314 Gene Therapy Administered in the Suprachoroidal Space for Participants With Neovascular Age-Related Macular Degeneration (nAMD) (AAVIATE)

Study Identifier
RGX-314-2102
CT.gov Identifier
NCT04514653
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

Recruiting
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Study Details

Medical Condition
  • Macular Degeneration - Other
    • Study Drug
  • Ranibizumab
  • Local Steroid
  • Topical Steroid
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    50 - 89 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Age \>/= 50 and \
    Exclusion Criteria:
    * CNV or macular edema in the study eye secondary to any causes other than AMD. * Subfoveal fibrosis or atrophy in study eye. * Participants who have had a prior vitrectomy. * Active or history of retinal detachment in the study eye. * History of intravitreal therapy in the study eye, such as intravitreal steroid injection or investigational product (IP), other than anti-VEGF therapy, in the 6 months prior to study entry. * Received any gene therapy. * Any condition preventing visualization of the fundus or VA improvement in the study eye, eg, cataract. * History of intraocular surgery in the study eye within 12 weeks of study entry. * Receipt of any IP within 30 days of study entry or 5 half-lives of the IP. * Myocardial infarction, cerebrovascular accident, or transient ischemic attacks within 6 months of study entry. * Cohorts 1 - 5 only: Uncontrolled glaucoma in the study eye. COHORT 6 ONLY: * Active or history of glaucoma or ocular hypertension in the study eye. * Certain OCT characteristics including: Large Pigment Epithelial Detachments (PED), clinically significant Epiretinal Membrane (ERM) in the study eye at Visit 1. Note: Other inclusion/exclusion criteria apply.

    Protocol Summary

    RGX-314 is being developed as a potential novel one-time gene therapy treatment for the treatment of neovascular (wet) age related macular degeneration (wet AMD). 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-VEGF therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to prevent progression of vision loss in the majority of patients. These therapies, however, require life-long intraocular injections, typically repeated every four to twelve weeks in frequency, to maintain efficacy. Due to the burden of treatment, patients often experience a decline in vision with reduced frequency of treatment over time.

    Study Locations

    Location
    Status
    Location
    Poway Location
    Poway, California, United States, 92064
    19.7 miles (31.5 km) away from your location
    Status
    Recruiting