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

Running, not enrolling · Phase 2

Conditions studied: Neovascular Age-Related Macular Degeneration (nAMD)

In brief

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 facts

Study ID

NCT04514653

Run by

AbbVie

People needed

146

Starts

2020-08-25

Expected to finish

2027-02-01

Last updated by the study team

2026-02-27

Who can join

Age: 50 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 steroid injection or investigational product (IP), other than anti-VEGF therapy, in the 6 months prior to study entry.
• Received any gene therapy.
• Any condition preventing visualization of the fundus or VA improvement in the study eye, 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 attacks within 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 ocular hypertension (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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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