Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT04514653
PHASE2

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

Sponsor: AbbVie

View on ClinicalTrials.gov

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

BIOLOGICAL

Ranibizumab

Ranibizumab (anti-VEGF agent)

GENETIC

ABBV-RGX-314 Dose 1

AAV8 vector containing a transgene for anti-VEGF fab (Dose 1)

GENETIC

ABBV-RGX-314 Dose 2

AAV8 vector containing a transgene for anti-VEGF fab (Dose 2)

GENETIC

ABBV-RGX-314 Dose 3

AAV8 vector containing a transgene for anti-VEGF fab (Dose 3)

DRUG

Local Steroid

Local steroid

DRUG

Topical Steroid

Topical steroid

GENETIC

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