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RGX-314 Gene Therapy Administered in the Suprachoroidal Space for Participants With Neovascular Age-Related Macular Degeneration (nAMD)
Sponsor: AbbVie
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.
Official title: 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)
Key Details
Gender
All
Age Range
50 Years - 89 Years
Study Type
INTERVENTIONAL
Enrollment
146
Start Date
2020-08-25
Completion Date
2027-02
Last Updated
2026-02-27
Healthy Volunteers
No
Interventions
Ranibizumab
Ranibizumab (anti-VEGF agent)
ABBV-RGX-314 Dose 1
AAV8 vector containing a transgene for anti-VEGF fab (Dose 1)
ABBV-RGX-314 Dose 2
AAV8 vector containing a transgene for anti-VEGF fab (Dose 2)
ABBV-RGX-314 Dose 3
AAV8 vector containing a transgene for anti-VEGF fab (Dose 3)
Local Steroid
Local steroid
Topical Steroid
Topical steroid
ABBV-RGX-314 Dose 4
AAV8 vector containing a transgene for anti-VEGF fab (Dose 4)
Locations (18)
Retinal Research Institute /ID# 255925
Phoenix, Arizona, United States
California Retina Consultants - Bakersfield /ID# 255910
Bakersfield, California, United States
Retina Vitreous Assoc Med Grp /ID# 255921
Beverly Hills, California, United States
Retinal Diagnostic Center /ID# 272275
Campbell, California, United States
Northern California Retina Vitreous Associates Medical Group, Inc /ID# 255920
Mountain View, California, United States
Retina Consultants of San Diego /ID# 255911
Poway, California, United States
California Retina Consultants - Santa Barbara /ID# 255923
Santa Barbara, California, United States
Southeast Retina Center /ID# 255912
Augusta, Georgia, United States
Springfield Clinic - First /ID# 272274
Springfield, Illinois, United States
Johns Hopkins Hospital /ID# 255919
Baltimore, Maryland, United States
Ophthalmic Consultants of Boston /ID# 255917
Boston, Massachusetts, United States
Sierra Eye Associates /ID# 255908
Reno, Nevada, United States
Eye Associates of New Mexico /ID# 255915
Albuquerque, New Mexico, United States
Duke University Medical Center /ID# 267646
Durham, North Carolina, United States
Mid Atlantic Retina /ID# 255906
Philadelphia, Pennsylvania, United States
Charles Retina Institute /ID# 255922
Germantown, Tennessee, United States
Tennessee Retina - Nashville /ID# 255918
Nashville, Tennessee, United States
Retina Consultants - The Woodlands /ID# 255924
The Woodlands, Texas, United States