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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
AbbVie
Study ID
NCT04514653
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Neovascular Age-Related Macular Degeneration (nAMD)

Eligibility Criteria

Sex
ALL
Age
50 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Ranibizumab — BIOLOGICAL
    Ranibizumab (anti-VEGF agent)
  • ABBV-RGX-314 Dose 1 — GENETIC
    AAV8 vector containing a transgene for anti-VEGF fab (Dose 1)
  • ABBV-RGX-314 Dose 2 — GENETIC
    AAV8 vector containing a transgene for anti-VEGF fab (Dose 2)
  • ABBV-RGX-314 Dose 3 — GENETIC
    AAV8 vector containing a transgene for anti-VEGF fab (Dose 3)
  • Local Steroid — DRUG
    Local steroid
  • Topical Steroid — DRUG
    Topical steroid
  • ABBV-RGX-314 Dose 4 — GENETIC
    AAV8 vector containing a transgene for anti-VEGF fab (Dose 4)

Study Details

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.

Key Dates

Start date
Aug 25, 2020
Status verified
Feb 2026
Primary completion
Aug 31, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
146 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Mean change from baseline in BCVA to Week 40 based on the Early Treatment Diabetic Retinopathy Study (ETDRS) score [ Time Frame: 40 weeks ]

Locations (18)

FacilityCityStateZIPSite coordinators
Retinal Research Institute /ID# 255925PhoenixArizona85053-
California Retina Consultants - Bakersfield /ID# 255910BakersfieldCalifornia93309-1677-
Retina Vitreous Assoc Med Grp /ID# 255921Beverly HillsCalifornia90211-
Retinal Diagnostic Center /ID# 272275CampbellCalifornia95008-
Northern California Retina Vitreous Associates Medical Group, Inc /ID# 255920Mountain ViewCalifornia94040-4101-
Retina Consultants of San Diego /ID# 255911PowayCalifornia92064-2530-
California Retina Consultants - Santa Barbara /ID# 255923Santa BarbaraCalifornia93103-
Southeast Retina Center /ID# 255912AugustaGeorgia30909-
Springfield Clinic - First /ID# 272274SpringfieldIllinois62702-
Johns Hopkins Hospital /ID# 255919BaltimoreMaryland21287-
Ophthalmic Consultants of Boston /ID# 255917BostonMassachusetts02114-
Sierra Eye Associates /ID# 255908RenoNevada89502-
Eye Associates of New Mexico /ID# 255915AlbuquerqueNew Mexico87109-
Duke University Medical Center /ID# 267646DurhamNorth Carolina27710-
Mid Atlantic Retina /ID# 255906PhiladelphiaPennsylvania19107-
Charles Retina Institute /ID# 255922GermantownTennessee38138-
Tennessee Retina - Nashville /ID# 255918NashvilleTennessee37203-1513-
Retina Consultants - The Woodlands /ID# 255924The WoodlandsTexas77384-

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Retinal Research Institute· Phoenix, AZCalifornia Retina Consultants - Bakersfield· Bakersfield, CARetina Vitreous Assoc Med Grp· Beverly Hills, CARetinal Diagnostic Center· Campbell, CANorthern California Retina Vitreous Associates Medical Group, Inc· Mountain View, CARetina Consultants of San Diego· Poway, CA

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