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Pivotal 1 Study of ABBV-RGX-314 (Also Known as RGX-314) Gene Therapy Administered Via Subretinal Delivery One Time in Participants With nAMD
NCT04704921 · View on ClinicalTrials.gov ↗
Study Summary
ABBV-RGX-314 (also known as RGX-314) is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD or nAMD). Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina. Wet AMD is a significant cause of vision loss in the United States, Europe and Japan, with up to 2 million people living with wet AMD in these geographies alone. Current anti-vascular endothelial growth factor (anti-VEGF) therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to maintain or prevent progression of vision loss in the majority of patients. These therapies, however, require life-long intraocular injections, typically repeated every 4 to 16 weeks in frequency, to maintain efficacy. Due to the burden of these treatments, patients often experience a decline in vision with reduced frequency of treatment over time.
Conditions Studied
Interventions
- GENETIC ABBV-RGX-314
- BIOLOGICAL Ranibizumab (LUCENTIS®)
Study Locations (20)
California
- Retina Vitreous Assoc Med Grp /ID# 256299 — Beverly Hills
- Retinal Diagnostic Center /ID# 256137 — Campbell
- The Retina Partners - Encino /ID# 256054 — Encino
- Retina Consultants of Orange County /ID# 256152 — Fullerton
- Salehi Retina Institute /ID# 263485 — Huntington Beach
- UC Irvine/Gavin Herbert Eye Institute /ID# 256145 — Irvine
- Northern California Retina Vitreous Associates Medical Group, Inc /ID# 256298 — Mountain View
- UCLA Doheny Eye Center /ID# 256120 — Pasadena
- California Eye Specialists Medical Group Inc. /ID# 256079 — Pasadena
- Retina Consultants of San Diego /ID# 256021 — Poway
- Retinal Consultants Medical Group /ID# 256047 — Sacramento
- West Coast Retina /ID# 256448 — San Francisco
- University of California, San Francisco /ID# 256130 — San Francisco
- Orange County Retina Medical Group /ID# 256073 — Santa Ana
- California Retina Consultants - Santa Barbara /ID# 256017 — Santa Barbara
Arizona
- Retinal Research Institute /ID# 256019 — Phoenix
- Barnet Dulaney Perkins Eye Center - Sun City /ID# 256055 — Sun City
Colorado
- Retina Consultants of Southern Colorado /ID# 256069 — Colorado Springs
- Southwest Retina Research Center /ID# 256136 — Durango
Arkansas
- University of Arkansas for Medical Sciences /ID# 271290 — Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 630 participants |
| Start Date | 2020-12-29 |
| Est. Completion | 2027-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04704921
The ClinicalTrials.gov registry entry for NCT04704921 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 630 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 9 conditions, with Neovascular Age-related Macular Degeneration appearing as the primary indexed condition, and to 2 interventions — of which ABBV-RGX-314 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04704921 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Arizona, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04704921 about?
NCT04704921 is a clinical study titled "Pivotal 1 Study of ABBV-RGX-314 (Also Known as RGX-314) Gene Therapy Administered Via Subretinal Delivery One Time in Participants With nAMD". ABBV-RGX-314 (also known as RGX-314) is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD or nAMD). Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina. Wet AMD is a signific...
What is the current status of trial NCT04704921?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 630 participants. The study started on 2020-12-29. Estimated completion is 2027-11.
What conditions does trial NCT04704921 study?
This clinical trial studies the following conditions: Neovascular Age-related Macular Degeneration, Choroidal Neovascularization, AMD, Wet Age-related Macular Degeneration, wAMD. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04704921?
The interventions under investigation include: ABBV-RGX-314 (GENETIC), Ranibizumab (LUCENTIS®) (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04704921?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04704921 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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