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Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD
NCT05407636 · 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). 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 (VEGF) therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to prevent progression of vision loss in the majority of patients. These therapies, however, require life-long intraocular injections, typically repeated every four to 12 weeks in frequency, to maintain efficacy. Due to the burden of treatment, patients often experience a decline in vision with reduced frequency of treatment over time. ABBV-RGX-314 is being developed as a potential one-time treatment for wet AMD.
Interventions
- GENETIC ABBV-RGX-314 Dose 1
- GENETIC ABBV-RGX-314 Dose 2
- BIOLOGICAL Aflibercept (EYLEA®)
Study Locations (20)
California
- California Retina Consultants - Bakersfield /ID# 256240 — Bakersfield
- Retina Vitreous Assoc Med Grp /ID# 256246 — Beverly Hills
- Retinal Diagnostic Center /ID# 256262 — Campbell
- The Retina Partners - Encino /ID# 259660 — Encino
- Retina Consultants of Orange County /ID# 256267 — Fullerton
- Hamilton Glaucoma Center Shiley Eye Center UCSD /ID# 256320 — La Jolla
- California Retina Consultants - Oxnard - North Ventura Road /ID# 262883 — Oxnard
- Byers Eye Institute Stanford /ID# 262853 — Palo Alto
- Retina Consultants of San Diego /ID# 256258 — Poway
- Kaiser Permanente - Riverside Medical Center /ID# 262413 — Riverside
- University of California Davis Health /ID# 256317 — Sacramento
- Retinal Consultants Medical Group, Inc. - Greenback /ID# 256353 — Sacramento
- Orange County Retina Medical Group /ID# 256286 — Santa Ana
- Macula Retina Vitreous Center - Torrance /ID# 270247 — Torrance
- Bay Area Retina Associates - Walnut Creek - Lennon Lane /ID# 268513 — Walnut Creek
Arizona
- Barnet Dulaney Eye Center-Phoenix /ID# 256340 — Phoenix
- Retinal Research Institute /ID# 256238 — Phoenix
- Retina Macula Institute of Arizona /ID# 271026 — Scottsdale
Colorado
- Retina Consultants of Southern Colorado /ID# 256285 — Colorado Springs
- Southwest Retina Research Center /ID# 256261 — Durango
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 660 participants |
| Start Date | 2022-01-13 |
| Est. Completion | 2027-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05407636
The ClinicalTrials.gov registry entry for NCT05407636 describes a study currently listed as recruiting. It is categorized as Phase 3, 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 660 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 6 conditions, with AMD appearing as the primary indexed condition, and to 3 interventions — of which ABBV-RGX-314 Dose 1 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: NCT05407636 reports 20 study locations spanning 3 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 NCT05407636 about?
NCT05407636 is a clinical study titled "Pivotal 2 Study of RGX-314 Gene Therapy 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). Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina. Wet AMD is a significant caus...
What is the current status of trial NCT05407636?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 660 participants. The study started on 2022-01-13. Estimated completion is 2027-11.
What conditions does trial NCT05407636 study?
This clinical trial studies the following conditions: AMD, Wet Age-related Macular Degeneration, wAMD, nAMD, CNV. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05407636?
The interventions under investigation include: ABBV-RGX-314 Dose 1 (GENETIC), ABBV-RGX-314 Dose 2 (GENETIC), Aflibercept (EYLEA®) (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05407636?
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 NCT05407636 being conducted?
This trial has 20 study locations across Arizona, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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