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

Last updated: February 25, 2026
Sponsor: AbbVie
Overall Status: Active - Not Recruiting

Phase

2

Condition

Macular Degeneration

Geographic Atrophy

Treatment

ABBV-RGX-314 Dose 1

ABBV-RGX-314 Dose 4

ABBV-RGX-314 Dose 2

Clinical Study ID

NCT04514653
RGX-314-2102 (M23-411)
M23-411
  • Ages 50-89
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • 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.

Exclusion

Exclusion Criteria:

  • CNV or macular edema in the study eye secondary to any causes other than AMD.

  • Subfoveal fibrosis or atrophy in study eye.

  • Participants who have had a prior vitrectomy.

  • Active or history of retinal detachment in the study eye.

  • History of intravitreal therapy in the study eye, such as intravitreal steroidinjection or investigational product (IP), other than anti-VEGF therapy, in the 6months prior to study entry.

  • Received any gene therapy.

  • Any condition preventing visualization of the fundus or VA improvement in the studyeye, eg, cataract.

  • History of intraocular surgery in the study eye within 12 weeks of study entry.

  • Receipt of any IP within 30 days of study entry or 5 half-lives of the IP.

  • Myocardial infarction, cerebrovascular accident, or transient ischemic attackswithin 6 months of study entry.

  • Cohorts 1 - 5 only: Uncontrolled glaucoma in the study eye.

COHORT 6 AND 7 ONLY:

  • Active or history of glaucoma or ocular hypertension (steroid-induced ocularhypertension (Cohort 7 only)) in the study eye.

  • Certain OCT characteristics including: Large Pigment Epithelial Detachments (PED),clinically significant Epiretinal Membrane (ERM) in the study eye at Visit 1.

Note: Other inclusion/exclusion criteria apply.

Study Design

Total Participants: 146
Treatment Group(s): 12
Primary Treatment: ABBV-RGX-314 Dose 1
Phase: 2
Study Start date:
August 25, 2020
Estimated Completion Date:
February 28, 2027

Study Description

This phase 2, randomized, dose-escalation study is designed to evaluate the efficacy, safety and tolerability of ABBV-RGX-314 gene therapy in subjects with nAMD.

ABBV-RGX-314 will be injected into the SCS part of the eye. Approximately 140 participants who meet the inclusion/exclusion criteria will be enrolled into one of 7 cohorts. Participants will be randomized in Cohorts 1 and 2 to receive ABBV-RGX-314 or the intravitreal ranibizumab control. Participants enrolled in Cohorts 3 through 5 will receive ABBV-RGX-314. Participants enrolled in Cohort 6 will receive ABBV-RGX-314 and will be randomized to one of two different post-procedural steroid regimens. Participants randomized in Cohort 7 will receive ABBV-RGX-314 with a protocol mandated steroid regimen or the intravitreal ranibizumab control. Cohort 1 will evaluate ABBV-RGX-314 Dose 1, Cohorts 2 and 3 will evaluate ABBV-RGX-314 Dose 2, Cohorts 4, 5, and 6 will evaluate ABBV-RGX-314 Dose 3, and Cohort 7 will evaluate ABBV-RGX-314 Dose 4.

The duration of the study will be up to 52 weeks or for ranibizumab control participants who cross over to ABBV-RGX-314, up to 80 weeks post-randomization.

Connect with a study center

  • Phoenix Location

    Phoenix, Arizona 85014
    United States

    Site Not Available

  • Retinal Research Institute /ID# 255925

    Phoenix 5308655, Arizona 5551752 85053
    United States

    Site Not Available

  • Bakersfield Location

    Bakersfield, California 93309
    United States

    Site Not Available

  • Beverly Hills Location

    Beverly Hills, California 90211
    United States

    Site Not Available

  • Mountain View Location

    Mountain View, California 94040
    United States

    Site Not Available

  • Poway Location

    Poway, California 92064
    United States

    Site Not Available

  • Santa Barbara Location

    Santa Barbara, California 93103
    United States

    Site Not Available

  • California Retina Consultants - Bakersfield /ID# 255910

    Bakersfield 5325738, California 5332921 93309-1677
    United States

    Site Not Available

  • Retina Vitreous Assoc Med Grp /ID# 255921

    Beverly Hills 5328041, California 5332921 90211
    United States

    Site Not Available

  • Retinal Diagnostic Center /ID# 272275

    Campbell 5333689, California 5332921 95008
    United States

    Site Not Available

  • Northern California Retina Vitreous Associates Medical Group, Inc /ID# 255920

    Mountain View 5375480, California 5332921 94040-4101
    United States

    Site Not Available

  • Retina Consultants of San Diego /ID# 255911

    Poway 5384690, California 5332921 92064-2530
    United States

    Site Not Available

  • California Retina Consultants - Santa Barbara /ID# 255923

    Santa Barbara 5392952, California 5332921 93103
    United States

    Site Not Available

  • Augusta Location

    Augusta, Georgia 30909
    United States

    Site Not Available

  • Southeast Retina Center /ID# 255912

    Augusta 4180531, Georgia 4197000 30909
    United States

    Site Not Available

  • Springfield Clinic - First /ID# 272274

    Springfield 4250542, Illinois 4896861 62702
    United States

    Site Not Available

  • Baltimore Location

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Johns Hopkins Hospital /ID# 255919

    Baltimore 4347778, Maryland 4361885 21287
    United States

    Site Not Available

  • Boston Location

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Ophthalmic Consultants of Boston /ID# 255917

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Site Not Available

  • Reno Location

    Reno, Nevada 89502
    United States

    Site Not Available

  • Sierra Eye Associates /ID# 255908

    Reno 5511077, Nevada 5509151 89502
    United States

    Site Not Available

  • Albuquerque Location

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • Eye Associates of New Mexico /ID# 255915

    Albuquerque 5454711, New Mexico 5481136 87109
    United States

    Site Not Available

  • Duke University Medical Center /ID# 267646

    Durham 4464368, North Carolina 4482348 27710
    United States

    Site Not Available

  • Philadelphia Location

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Mid Atlantic Retina /ID# 255906

    Philadelphia 4560349, Pennsylvania 6254927 19107
    United States

    Site Not Available

  • Germantown Location

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Nashville Location

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Charles Retina Institute /ID# 255922

    Germantown 4624601, Tennessee 4662168 38138
    United States

    Site Not Available

  • Tennessee Retina - Nashville /ID# 255918

    Nashville 4644585, Tennessee 4662168 37203-1513
    United States

    Site Not Available

  • Woodlands Location

    The Woodlands, Texas 77384
    United States

    Site Not Available

  • Retina Consultants - The Woodlands /ID# 255924

    The Woodlands 4736476, Texas 4736286 77384
    United States

    Site Not Available

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