RGX-314 Gene Therapy Pharmacodynamic Study for Neovascular Age-related Macular Degeneration (nAMD)

Study Identifier
RGX-314-2103
CT.gov Identifier
NCT04832724
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
  • Macular Degeneration - Wet Age-Related Macular Degeneration (wAMD)
    • Study Drug
    N/A
    Phase
    Phase 2
    Sex
    Female & Male
    Age
    50 - 89 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    1. Males or females, aged ≥ 50 years and ≤ 89 years. 2. An Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA-letter score between ≤ 78 and ≥ 40 in the study eye at Screening. 3. Diagnosis of choroidal neovascularization (CNV) secondary to age-related macular degeneration in the study eye previously treated with anti-VEGF. 4. Participants must have demonstrated a meaningful response to anti-VEGF therapy at study entry. 5. Willing and able to provide written, signed informed consent for this study. 6. Must be pseudophakic (at least 12 weeks postcataract surgery) in the study eye.
    Exclusion Criteria:
    1. CNV or macular edema in the study eye secondary to any causes other than AMD. 2. Subfoveal fibrosis or atrophy in study eye. 3. Any condition in the investigator's opinion that could limit visual acuity improvement in the study eye. 4. Active or history of retinal detachment or retinal tear in the study eye. 5. Advanced glaucoma in the study eye. 6. Prior treatment with gene therapy. 7. Myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months.

    Protocol Summary

    RGX-314 is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (nAMD) also referred to as Wet AMD. Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina. The purpose of this phase 2, open label study is to evaluate whether different doses of RGX-314 from two different formulations (clinical versus eventual commercial formulation) perform the same in humans when delivered by subretinal administration

    Study Locations

    Location
    Status
    Location
    Retinal Consultants of Arizona
    Phoenix, Arizona, United States, 85014
    Status
    Not applicable
    Location
    Barnet Dulaney Perkins Eye Center
    Sun City, Arizona, United States, 85351
    Status
    Not applicable
    Location
    Retina Consultants of San Diego
    San Diego, California, United States, 92064
    Status
    Not applicable
    Location
    California Retina Consultants
    Santa Barbara, California, United States, 93103
    Status
    Not applicable
    Location
    Retina Vitreous Associates of Florida
    St. Petersburg, Florida, United States, 33711
    Status
    Not applicable
    Location
    Wilmer Eye Institute
    Baltimore, Maryland, United States, 21287
    Status
    Not applicable
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