Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD (ASCENT)
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, Aflibercept, 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
- Barnet Dulaney Perkins Eye CenterRecruiting
- Retinal Consultants of ArizonaRecruiting
- Retinal Research InstituteRecruiting
- California Retina ConsultantsRecruiting
- Retina Vitreous Associates Medical GroupRecruiting
- Retinal Diagnostic CenterRecruiting
- The Retina PartnersRecruiting
- UC San DiegoRecruiting
- Retina Consultants of San DiegoRecruiting
- Retinal Consultants Medical Group, IncRecruiting
- UC DavisRecruiting
- Orange County Retina Medical GroupRecruiting
- Retina Consultants of Southern Colorado P.C.Recruiting
- Southwest Retina ConsultantsRecruiting
- Colorado Retina AssociatesRecruiting
- Eye Care Center of Northern ColoradoRecruiting
- National Ophthalmic Research InstituteRecruiting
- Vitreo Retinal Associates PARecruiting
- Florida Retina ConsultantsRecruiting
- Florida Retina InstituteRecruiting
- Retina Specialty InstituteRecruiting
- Rand Eye InstituteRecruiting
- Retina Vitreous Associates of Florida - Saint PetersburgRecruiting
- Center for Retina and Macular DiseaseRecruiting
- Georgia Retina PCRecruiting
- Retina Consultants of HawaiiRecruiting
- University Retina and Macula Associates, P.C.Recruiting
- University Retina and Macula Associates, P.C.Recruiting
- Illinois Retina AssociatesRecruiting
- Springfield ClinicRecruiting
- MidWest Eye InstituteRecruiting
- John-Kenyon American Eye InstituteRecruiting
- Wolfe Eye ClinicRecruiting
- Maine Eye CenterRecruiting
- Retina SpecialistsRecruiting
- Johns Hopkins UniversityRecruiting
- Wilmer Eye InstituteRecruiting
- Mid Atlantic Reina SpecialistsRecruiting
- Massachusetts Eye and Ear InfirmaryRecruiting
- Ophthalmic Consultants of Boston, IncRecruiting
- Retina Associates of MichiganRecruiting
- Associated Retinal ConsultantsRecruiting
- Vitreo Retinal Surgery, PARecruiting
- Sierra Eye AssociatesRecruiting
- Envision Ocular, LLCRecruiting
- Columbia University Irving Medical Center - Harness Eye InstituteRecruiting
- Retina Associates of Western New YorkRecruiting
- Western Carolina Retina Associates P.A.Recruiting
- Duke Eye CenterRecruiting
- Greystone EyeRecruiting
- Cincinnati Eye InstituteRecruiting
- Retina Associates of Cleveland, Inc.Recruiting
- Cleveland ClinicRecruiting
- The Ohio State University Eye & Ear InstituteRecruiting
- Retina Vitreous Center ResearchRecruiting
- Scheie Eye InstituteRecruiting
- Mid Atlantic RetinaRecruiting
- University of Pittsburgh Medical CenterRecruiting
- Retina Consultants of CharlestonRecruiting
- Retina Consulants of CharlestonRecruiting
- Palmetto Retina Center LLCRecruiting
- Retina Consultants of CharlestonRecruiting
- Southeastern Retina AssociatesRecruiting
- Charles Retina InstituteRecruiting
- Southeastern Retina AssociatesRecruiting
- Tennessee Retina Center MurfreesboroRecruiting
- Vanderbilt University Medical CenterRecruiting
- Retina Research Institute of TexasRecruiting
- West Texas Retina Consultants - AbileneRecruiting
- Texas Retina AssociatesRecruiting
- Retina Consultants of AustinRecruiting
- Austin Clinical Research, LLCRecruiting
- Retina Consultants of TexasRecruiting
- Star RetinaRecruiting
- Ophthalmology Surgery Center of DallasRecruiting
- Texas Retina AssociatesRecruiting
- Austin Retina AssociatesRecruiting
- Retina Associates of South Texas, P.A.Recruiting
- Retina Consultants of TexasRecruiting
- Brown Retina InstituteRecruiting
- Retina Center of Texas - SouthlakeRecruiting
- Rocky Mountain Retina ConsultantsRecruiting
- Piedmont Eye CenterRecruiting
- Wagner Macula & Retina CenterRecruiting
- Retina Institute of VirginiaRecruiting
- Pacific Northwest RetinaRecruiting
- Vitreoretinal Associates of WashingtonRecruiting
- Retina Center NorthwestRecruiting
- Spokane Eye Clinical ResearchRecruiting
- Calgary Retina ConsultantsRecruiting
- Alberta Retina Research CorporationRecruiting
- Retina Centre of OttawaRecruiting
- CHU de Quebec-Universite LavalRecruiting
- Emanuelli Research and Development CenterRecruiting
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.
Aflibercept administered via intravitreal injection approximately every 8 weeks