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 (18) locations...
Intervention Type: Genetic, Drug, Biological
Study Type: Interventional
Study Phase: Phase 2
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.

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
Retinal Research Institute /ID# 255925
RECRUITING
Phoenix
California
California Retina Consultants - Bakersfield /ID# 255910
RECRUITING
Bakersfield
Retina Vitreous Assoc Med Grp /ID# 255921
RECRUITING
Beverly Hills
Retinal Diagnostic Center /ID# 272275
RECRUITING
Campbell
Northern California Retina Vitreous Associates Medical Group, Inc /ID# 255920
RECRUITING
Mountain View
Retina Consultants of San Diego /ID# 255911
RECRUITING
Poway
California Retina Consultants - Santa Barbara /ID# 255923
COMPLETED
Santa Barbara
Georgia
Southeast Retina Center /ID# 255912
RECRUITING
Augusta
Illinois
Springfield Clinic - First /ID# 272274
RECRUITING
Springfield
Massachusetts
Ophthalmic Consultants of Boston /ID# 255917
RECRUITING
Boston
Maryland
Johns Hopkins Hospital /ID# 255919
RECRUITING
Baltimore
North Carolina
Duke University Medical Center /ID# 267646
RECRUITING
Durham
New Mexico
Eye Associates of New Mexico /ID# 255915
RECRUITING
Albuquerque
Nevada
Sierra Eye Associates /ID# 255908
RECRUITING
Reno
Pennsylvania
Mid Atlantic Retina /ID# 255906
RECRUITING
Philadelphia
Tennessee
Charles Retina Institute /ID# 255922
COMPLETED
Germantown
Tennessee Retina - Nashville /ID# 255918
COMPLETED
Nashville
Texas
Retina Consultants - The Woodlands /ID# 255924
RECRUITING
The Woodlands
Contact Information
Primary
Patient Advocacy
patientadvocacy@regenxbio.com
1-866-860-0117
Time Frame
Start Date: 2020-08-25
Estimated Completion Date: 2027-02
Participants
Target number of participants: 140
Treatments
Active_comparator: Ranibizumab control
Control treatment arm
Experimental: ABBV-RGX-314 Treatment Arm (Dose 1)
ABBV-RGX-314 Dose 1
Experimental: ABBV-RGX-314 Treatment Arm (Dose 2)
ABBV-RGX-314 Dose 2
Experimental: ABBV-RGX-314 Treatment Arm (Dose 3)
ABBV-RGX-314 Dose 3
Experimental: ABBV-RGX-314 Treatment Arm (Dose 3) and Local Steroid
ABBV-RGX-314 Dose 3 and Local Steroid
Experimental: ABBV-RGX-314 Treatment Arm (Dose 3) and Topical Steroid
ABBV-RGX-314 Dose 3 and Topical Steroid
Experimental: ABBV-RGX-314 Treatment Arm (Dose 4) and Topical Steroid
ABBV-RGX-314 Dose 4 and Topical Steroid
Sponsors
Leads: AbbVie
Collaborators: REGENXBIO Inc.

This content was sourced from clinicaltrials.gov

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