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

NCT04514653 · tracked via the Priya Life Science USA tracker

Sponsor

AbbVie

Phase

Phase 2

Started

2020-08-25

Last updated

2026-02-27

Condition(s) studied

Neovascular Age-Related Macular Degeneration (nAMD)

Investigational drug(s) / intervention(s)

RanibizumabABBV-RGX-314 Dose 1ABBV-RGX-314 Dose 2ABBV-RGX-314 Dose 3Local SteroidTopical SteroidABBV-RGX-314 Dose 4

Ranibizumab: Ranibizumab (anti-VEGF agent)

ABBV-RGX-314 Dose 1: AAV8 vector containing a transgene for anti-VEGF fab (Dose 1)

ABBV-RGX-314 Dose 2: AAV8 vector containing a transgene for anti-VEGF fab (Dose 2)

ABBV-RGX-314 Dose 3: AAV8 vector containing a transgene for anti-VEGF fab (Dose 3)

Local Steroid: Local steroid

Topical Steroid: Topical steroid

ABBV-RGX-314 Dose 4: AAV8 vector containing a transgene for anti-VEGF fab (Dose 4)

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

Sex

ALL

Min age

50 Years

Max age

89 Years

Healthy volunteers

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 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 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.

Primary outcome measure(s)

Mean change from baseline in BCVA to Week 40 based on the Early Treatment Diabetic Retinopathy Study (ETDRS) score — 40 weeks
The scale used is the early treatment diabetic retinopathy study (ETDRS) letter score from 0-100 and higher score being better vision.

Trial sites (18)

Facility	City	Region
Retinal Research Institute /ID# 255925	Phoenix	Arizona
California Retina Consultants - Bakersfield /ID# 255910	Bakersfield	California
Retina Vitreous Assoc Med Grp /ID# 255921	Beverly Hills	California
Retinal Diagnostic Center /ID# 272275	Campbell	California
Northern California Retina Vitreous Associates Medical Group, Inc /ID# 255920	Mountain View	California
Retina Consultants of San Diego /ID# 255911	Poway	California
California Retina Consultants - Santa Barbara /ID# 255923	Santa Barbara	California
Southeast Retina Center /ID# 255912	Augusta	Georgia
Springfield Clinic - First /ID# 272274	Springfield	Illinois
Johns Hopkins Hospital /ID# 255919	Baltimore	Maryland
Ophthalmic Consultants of Boston /ID# 255917	Boston	Massachusetts
Sierra Eye Associates /ID# 255908	Reno	Nevada
Eye Associates of New Mexico /ID# 255915	Albuquerque	New Mexico
Duke University Medical Center /ID# 267646	Durham	North Carolina
Mid Atlantic Retina /ID# 255906	Philadelphia	Pennsylvania
Charles Retina Institute /ID# 255922	Germantown	Tennessee
Tennessee Retina - Nashville /ID# 255918	Nashville	Tennessee
Retina Consultants - The Woodlands /ID# 255924	The Woodlands	Texas

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04514653 on ClinicalTrials.gov ↗ ← All trials in the USA