Long-term Follow-Up Study of RGX-314 and Fellow Eye Substudy

Study Identifier
RGX-314-5101
CT.gov Identifier
NCT03999801
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

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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+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    Main Observational Study: Inclusion Criteria: 1. Able and willing to provide written consent 2. Previously enrolled in a clinical study of RGX-314 and received a single subretinal administration of RGX-314 Exclusions Criteria: 1\. None Fellow Eye Substudy: Inclusion Criteria 1. Age ≤ 93 years 2. Currently or previously enrolled in the main observational study 3. Diagnosis of bilateral choroidal neovascularization secondary to age-related macular degeneration 4. Active nAMD in the fellow eye 5. BCVA between ≤ 80 and ≥ 20 letters in the fellow eye Exclusion Criteria: 1. CNV or macular edema in the fellow eye secondary to causes other than nAMD 2. Subfoveal fibrosis or atrophy in the fellow eye 3. Advanced glaucoma or history of secondary glaucoma in the fellow eye or any invasive procedure to treat glaucoma 4. Myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months 5. History of intraocular surgery in the fellow eye within 12 weeks of screening 6. History of intravitreal therapy, such as intravitreal steroid injection or investigational product, other than an intravitreal therapy for nAMD, in the fellow eye within 6 months of screening

    Protocol Summary

    This is a prospective, observational study designed to evaluate the long-term safety and efficacy of RGX-314. Eligible participants are those who were previously enrolled in a clinical study in which they received a single subretinal administration of RGX-314 in their study eye. Enrollment of each participant in the current study should occur after the participant has completed either the end of study or early termination visit in the previous (parent) clinical study. Participants will be followed for up to 5 years post-RGX-314 administration (inclusive of the parent study). After enrollment and a 6-month follow-up visit, participants will attend at least annual study visits through the end of the 5-year post-RGX-314 administration follow-up period.

    Additionally, an interventional fellow eye treatment substudy will evaluate the safety, efficacy, and immunogenicity of subretinal RGX-314 administration in the fellow eye of participants having bilateral disease who previously received a subretinal injection of RGX-314 in their study eye. Participants who qualify for the substudy will receive subretinal administration of RGX-314 in their fellow eye and complete 13 study visits in a 54-week period. Following completion of the substudy participants will continue in the observational portion of the study for up to 5 years post RGX-314 administration in their fellow eye.

    Study Locations

    Location
    Status
    Location
    Retinal Research Institute, LCC
    Phoenix, Arizona, United States, 85053
    Status
    Not applicable
    Location
    California Retina Consultants CRC
    Santa Barbara, California, United States, 93103
    Status
    Not applicable
    Location
    Johns Hopkins University
    Baltimore, Maryland, United States, 21287
    Status
    Not applicable
    Location
    Ophthalmic Consultants of Boston
    Boston, Massachusetts, United States, 02114
    Status
    Not applicable
    Location
    Sierra Eye Associates
    Reno, Nevada, United States, 89502
    Status
    Not applicable
    Location
    University of Pennsylvania Department of Ophthalmology
    Philadelphia, Pennsylvania, United States, 19104
    Status
    Not applicable
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