Pivotal 1 Study of RGX-314 Gene Therapy in Participants With nAMD (ATMOSPHERE)
AMD, nAMD, Wet Age-related Macular Degeneration
About this trial
This is an interventional treatment trial for AMD focused on measuring Age-Related Macular Degeneration, Neovascular Age-Related Macular Degeneration, Macular Degeneration, Wet Macular Degeneration, Choroidal Neovascularization, Retinal Degeneration, Retinal Diseases, Eye Diseases, Ranibizumab, Angiogenesis Inhibitors, Angiogenesis Modulating Agents, Growth Substances, Physiological Effects of Drugs, Growth Inhibitors, Antineoplastic Agents, Gene therapy, Anti-vascular endothelial grown factory therapy, Anti-VEGF therapy
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 50 years and ≤ 89 years
- An ETDRS BCVA letter score between ≤ 78 and ≥ 40 in the study eye
- Diagnosis of subfoveal CNV secondary to AMD in the study eye previously treated with anti-VEGF
- Must be pseudophakic (at least 12 weeks postcataract surgery) in the study eye.
- Willing and able to provide written, signed informed consent for this study
- Participants must have demonstrated a meaningful response to anti-VEGF therapy at study entry
Exclusion Criteria:
- CNV or macular edema in the study eye secondary to any causes other than AMD
- Subfoveal fibrosis or atrophy in the study eye
- Any condition in the investigator's opinion that could limit VA improvement in the study eye
- Active or history of retinal detachment in the study eye
- Uncontrolled glaucoma in the study eye
- History of intraocular surgery in the study eye within 12 weeks prior to Screening Visit 1
- History of intravitreal therapy in the study eye, such as intravitreal steroid injection or investigational product, other than anti-VEGF therapy, in the 6 months prior to Screening Visit 1.
- Prior treatment with gene therapy.
- Recent myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months.
Sites / Locations
- Retinal Consultants of Arizona, Ltd.Recruiting
- Barnet Dulaney Perkins Eye Center - PhoenixRecruiting
- Retina-Vitreous Associates Medical GroupRecruiting
- Retinal Diagnostic CenterRecruiting
- The Retina Partners - EncinoRecruiting
- Retina Consultants of Orange County - Fullerton OfficeRecruiting
- University of California Irvine - School of Medicine - The Gavin Herbert Eye InstituteRecruiting
- Doheny Eye Institute - Doheny Eye Center - ArcadiaRecruiting
- Northern California Retina Vitreous Associates Medical Group, Inc. - Mountain View OfficeRecruiting
- California Eye Specialists Medical Group Inc. - PasadenaRecruiting
- Retina Consultants San DiegoRecruiting
- Retina ConsultantsRecruiting
- West Coast Retina Medical Group - San Francisco OfficeRecruiting
- UCSF Medical Center - Retina and Vitreous ClinicRecruiting
- Orange County Retina Medical GroupRecruiting
- California Retina ConsultantsRecruiting
- Retina Consultants of Southern Colorado PC- Colorado SpringsRecruiting
- Southwest Retina ConsultantsRecruiting
- Colorado Retina Associates (CRA) - Red Rocks Medical Center LocationRecruiting
- Retina Group of New England - New LondonRecruiting
- Vitreo Retinal Associates PA - The Millennium CenterRecruiting
- Florida Retina Consultants - Lakeland
- Bascom Palmer Eye Institute - University of Miami Health SystemRecruiting
- Retina Specialty Institute - PensacolaRecruiting
- Retina Vitreous Associates of Florida (RVA) - Saint PetersburgRecruiting
- Southern Vitreoretinal Associates, P.L.
- Southeast Retina Center
- Georgia Retina PC - MariettaRecruiting
- Retina Consultants of Hawaii (RCH) - Pali Momi Medical Center LocationRecruiting
- Illinois Eye and Ear Infirmary at UI Health UICRecruiting
- University Retina and Macula Associates, P.C. - Lemont OfficeRecruiting
- University Retina and Macula Associates, PC - Oak ForestRecruiting
- Springfield Clinic
- Springfield Clinic
- Midwest Eye InstituteRecruiting
- John-Kenyon American Eye Institute - New AlbanyRecruiting
- Retina Associates, P.A. - Shawnee MissionRecruiting
- The Retina Care Center, LLCRecruiting
- The Johns Hopkins Hospital - Wilmer Eye Institute - East BaltimoreRecruiting
- Cumberland Valley Retina Consultants (CVRC)Recruiting
- Ophthalmic Consultants of Boston, Inc.Recruiting
- Retina Associates of Michigan - Grand Blanc Office
- Associated Retinal Consultants P.C.Recruiting
- VitreoRetinal Surgery, PA - Edina LocationRecruiting
- Mayo Clinic - MinnesotaRecruiting
- Sierra Eye AssociatesRecruiting
- Eye Associates of New Mexico - Albuquerque - Retina Center LocationRecruiting
- Long Island Vitreoretinal Consultants - Great NeckRecruiting
- Duke Eye Center - Erwin Road - Duke University Medical CenterRecruiting
- Wake Forest Baptist Medical Center
- Cincinnati Eye Institute - Blue AshRecruiting
- Retina Associates of Cleveland, Inc. - Middleburg Heights OfficeRecruiting
- Cleveland ClinicRecruiting
- Retina Vitreous Center (RVC)Recruiting
- Retina Northwest, PCRecruiting
- Erie Retinal Surgery, IncRecruiting
- Mid Atlantic Retina - PhiladelphiaRecruiting
- Charleston Neuroscience InstituteRecruiting
- Black Hills Regional Eye InstituteRecruiting
- Charles Retina InstituteRecruiting
- West Texas Retina Consultants (WTRC) - Abilene LocationRecruiting
- Austin Retina AssociatesRecruiting
- Retina Consultants of AustinRecruiting
- Austin Clinical Research, LLCRecruiting
- Star RetinaRecruiting
- Texas Retina AssociatesRecruiting
- Star Vision Consultants
- Retina Associates of South Texas, PA - San Antonio
- Retinal Consultants of San Antonio (RCSA) - Medical Center
- Retina Center of Texas - SouthlakeRecruiting
- Retina Consultants of Texas - The WoodlandsRecruiting
- Retina Associates of Utah, PCRecruiting
- John A. Moran Eye Center - University of Utah Health CareRecruiting
- Wagner Macula & Retina CenterRecruiting
- Pacific Northwest RetinaRecruiting
- Retina Center Northwest - SilverdaleRecruiting
- University of Wisconsin Health - University Station ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
RGX-314 Dose 1
RGX-314 Dose 2
Control Arm
RGX-314 Dose 1 administered via subretinal delivery one time.
RGX-314 Dose 2 administered via subretinal delivery one time.
Ranibizumab administered via intravitreal injection approximately every 28 days