RGX-314 Gene Therapy Administered in the Suprachoroidal Space for Participants With Neovascular Age-Related Macular Degeneration (nAMD)
Public ClinicalTrials.gov record NCT04514653. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Randomized, Dose-escalation, Ranibizumab-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of RGX-314 Gene Therapy Delivered Via One or Two Suprachoroidal Space (SCS) Injections in Participants With Neovascular Age-Related Macular Degeneration (nAMD) (AAVIATE)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04514653
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 146 participants
Conditions and interventions
Interventions
- Ranibizumab Biological
- ABBV-RGX-314 Dose 1 Genetic
- ABBV-RGX-314 Dose 2 Genetic
- ABBV-RGX-314 Dose 3 Genetic
- Local Steroid Drug
- Topical Steroid Drug
- ABBV-RGX-314 Dose 4 Genetic
Biological · Genetic · Drug
Eligibility (public fields only)
- Age range
- 50 Years to 89 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 24, 2020
- Primary completion
- Jul 31, 2026
- Completion
- Jan 31, 2027
- Last update posted
- Feb 26, 2026
2020 – 2027
United States locations
- U.S. sites
- 18
- U.S. states
- 12
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Retinal Research Institute /ID# 255925 | Phoenix | Arizona | 85053 | — |
| California Retina Consultants - Bakersfield /ID# 255910 | Bakersfield | California | 93309-1677 | — |
| Retina Vitreous Assoc Med Grp /ID# 255921 | Beverly Hills | California | 90211 | — |
| Retinal Diagnostic Center /ID# 272275 | Campbell | California | 95008 | — |
| Northern California Retina Vitreous Associates Medical Group, Inc /ID# 255920 | Mountain View | California | 94040-4101 | — |
| Retina Consultants of San Diego /ID# 255911 | Poway | California | 92064-2530 | — |
| California Retina Consultants - Santa Barbara /ID# 255923 | Santa Barbara | California | 93103 | — |
| Southeast Retina Center /ID# 255912 | Augusta | Georgia | 30909 | — |
| Springfield Clinic - First /ID# 272274 | Springfield | Illinois | 62702 | — |
| Johns Hopkins Hospital /ID# 255919 | Baltimore | Maryland | 21287 | — |
| Ophthalmic Consultants of Boston /ID# 255917 | Boston | Massachusetts | 02114 | — |
| Sierra Eye Associates /ID# 255908 | Reno | Nevada | 89502 | — |
| Eye Associates of New Mexico /ID# 255915 | Albuquerque | New Mexico | 87109 | — |
| Duke University Medical Center /ID# 267646 | Durham | North Carolina | 27710 | — |
| Mid Atlantic Retina /ID# 255906 | Philadelphia | Pennsylvania | 19107 | — |
| Charles Retina Institute /ID# 255922 | Germantown | Tennessee | 38138 | — |
| Tennessee Retina - Nashville /ID# 255918 | Nashville | Tennessee | 37203-1513 | — |
| Retina Consultants - The Woodlands /ID# 255924 | The Woodlands | Texas | 77384 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04514653, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 26, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04514653 live on ClinicalTrials.gov.