A Phase 2, Randomized, Dose-escalation, Ranibizumab-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of RGX-314 Gene Therapy Delivered Via One or Two Suprachoroidal Space (SCS) Injections in Participants With Neovascular Age-Related Macular Degeneration (nAMD) (AAVIATE)
Who is this study for? Patients with Neovascular Age-Related Macular Degeneration (nAMD)
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Genetic, Drug, Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
RGX-314 is being developed as a potential novel one-time gene therapy treatment for the treatment of neovascular (wet) age related macular degeneration (wet AMD). Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina. Wet AMD is a significant cause of vision loss in the United States, Europe and Japan, with up to 2 million people living with wet AMD in these geographies alone. Current anti-VEGF therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to prevent progression of vision loss in the majority of patients. These therapies, however, require life-long intraocular injections, typically repeated every four to twelve weeks in frequency, to maintain efficacy. Due to the burden of treatment, patients often experience a decline in vision with reduced frequency of treatment over time.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 89
Healthy Volunteers: f
View:
• Age \>/= 50 and \</= 89
• Diagnosis of CNV secondary to age-related macular degeneration in the study eye.
• Participants must have demonstrated a meaningful response to anti-VEGF therapy.
• Willing and able to provide written, signed informed consent for this study.
Locations
United States
Arizona
Phoenix Location
RECRUITING
Phoenix
California
Bakersfield Location
ACTIVE_NOT_RECRUITING
Bakersfield
Beverly Hills Location
RECRUITING
Beverly Hills
Mountain View Location
RECRUITING
Mountain View
Poway Location
RECRUITING
Poway
Santa Barbara Location
ACTIVE_NOT_RECRUITING
Santa Barbara
Georgia
Augusta Location
RECRUITING
Augusta
Massachusetts
Boston Location
RECRUITING
Boston
Maryland
Baltimore Location
RECRUITING
Baltimore
New Mexico
Albuquerque Location
RECRUITING
Albuquerque
Nevada
Reno Location
RECRUITING
Reno
Pennsylvania
Philadelphia Location
RECRUITING
Philadelphia
Tennessee
Germantown Location
ACTIVE_NOT_RECRUITING
Germantown
Nashville Location
ACTIVE_NOT_RECRUITING
Nashville
Texas
Woodlands Location
ACTIVE_NOT_RECRUITING
The Woodlands
Contact Information
Primary
Patient Advocacy
patientadvocacy@regenxbio.com
1-833-711-0349
Time Frame
Start Date:2020-08-25
Estimated Completion Date:2026-08-01
Participants
Target number of participants:115
Treatments
Active_comparator: Ranibizumab control
Control treatment arm
Experimental: RGX-314 Treatment Arm (Dose 1)
RGX-314 Dose 1
Experimental: RGX-314 Treatment Arm (Dose 2)
RGX-314 Dose 2
Experimental: RGX-314 Treatment Arm (Dose 3)
RGX-314 Dose 3
Experimental: RGX-314 Treatment Arm (Dose 3) and Local Steroid
RGX-314 Dose 3 and Local Steroid
Experimental: RGX-314 Treatment Arm (Dose 3) and Topical Steroid