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

Study Identifier
RGX-314-2102 (M23-411)
CT.gov Identifier
NCT04514653
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Recruitment Complete
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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 AND 7 ONLY: * Active or history of glaucoma or ocular hypertension (steroid-induced ocular hypertension (Cohort 7 only)) 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

    This interventional study is being conducted with an investigational gene therapy treatment called ABBV-RGX-314 (also known as RGX-314) and is being developed as a potential one-time gene therapy treatment for neovascular (wet) age-related macular degeneration (wet AMD or nAMD). The typical treatment for nAMD is frequent injections of anti-VEGF therapy. Researchers are testing ABBV-RGX-314 to see if it has similar effects as the current approved standard of care, such as Lucentis® or Eylea® injections.

    The duration of this study will be up to 52 weeks or for ranibizumab control participants who cross over to ABBV-RGX-314 after week 52, up to 80 weeks post-randomization.

    The primary outcome measure for this investigational study is to evaluate the mean change in best-corrected visual acuity (BCVA) for ABBV-RGX-314 compared with ranibizumab monthly at the Week 40 visit.

    Study Locations

    Location
    Status
    Location
    Retinal Research Institute /ID# 255925
    Phoenix, Arizona, United States, 85053
    Status
    Not applicable
    Location
    California Retina Consultants - Bakersfield /ID# 255910
    Bakersfield, California, United States, 93309-1677
    Status
    Not applicable
    Location
    Retina Vitreous Assoc Med Grp /ID# 255921
    Beverly Hills, California, United States, 90211
    Status
    Not applicable
    Location
    Retinal Diagnostic Center /ID# 272275
    Campbell, California, United States, 95008
    Status
    Not applicable
    Location
    Northern California Retina Vitreous Associates Medical Group, Inc /ID# 255920
    Mountain View, California, United States, 94040-4101
    Status
    Not applicable
    Location
    Retina Consultants of San Diego /ID# 255911
    Poway, California, United States, 92064-2530
    Status
    Not applicable
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