NCT04514653Active, not recruitingPhase 2
RGX-314 Gene Therapy Administered in the Suprachoroidal Space for Participants With Neovascular Age-Related Macular Degeneration (nAMD)
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)
Source: ClinicalTrials.gov · Last updated 27 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 146 (actual)
- First submitted
- 4 Aug 2020
- Start date
- 25 Aug 2020
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- AbbVie
- Diseases
- Macular degeneration
- NCT number
- NCT04514653
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 146
- From 25 Aug 2020 to the primary completion date, 31 Aug 2026
- 18 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants who have had a prior vitrectomy.
- 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.
Other illness
- Active or history of retinal detachment in the study eye.
- 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.
- Myocardial infarction, cerebrovascular accident, or transient ischemic attacks within 6 months of study entry.
- Active or history of glaucoma or ocular hypertension (steroid-induced ocular hypertension (Cohort 7 only)) in the study eye.
Other
- CNV or macular edema in the study eye secondary to any causes other than AMD.
- Subfoveal fibrosis or atrophy in study eye.
- Receipt of any IP within 30 days of study entry or 5 half-lives of the IP.
- Cohorts 1 - 5 only: Uncontrolled glaucoma in the study eye.
- COHORT 6 AND 7 ONLY:
- 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.
Who the study is looking for
- 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.
Age in the registry: 50 years to 89 years · Sex: All · Does not accept healthy volunteers
Sites (18)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Eye Associates of New Mexico /ID# 255915 Coordinator of this site? Confirm its status | Albuquerque | United States | Unknown status |
| Southeast Retina Center /ID# 255912 Coordinator of this site? Confirm its status | Augusta | United States | Unknown status |
| California Retina Consultants - Bakersfield /ID# 255910 Coordinator of this site? Confirm its status | Bakersfield | United States | Unknown status |
| Johns Hopkins Hospital /ID# 255919 Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Retina Vitreous Assoc Med Grp /ID# 255921 Coordinator of this site? Confirm its status | Beverly Hills | United States | Unknown status |
| Ophthalmic Consultants of Boston /ID# 255917 Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Retinal Diagnostic Center /ID# 272275 Coordinator of this site? Confirm its status | Campbell | United States | Unknown status |
| Duke University Medical Center /ID# 267646 Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Charles Retina Institute /ID# 255922 Coordinator of this site? Confirm its status | Germantown | United States | Unknown status |
| Northern California Retina Vitreous Associates Medical Group, Inc /ID# 255920 Coordinator of this site? Confirm its status | Mountain View | United States | Unknown status |
| Tennessee Retina - Nashville /ID# 255918 Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Mid Atlantic Retina /ID# 255906 Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Retinal Research Institute /ID# 255925 Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Retina Consultants of San Diego /ID# 255911 Coordinator of this site? Confirm its status | Poway | United States | Unknown status |
| Sierra Eye Associates /ID# 255908 Coordinator of this site? Confirm its status | Reno | United States | Unknown status |
| California Retina Consultants - Santa Barbara /ID# 255923 Coordinator of this site? Confirm its status | Santa Barbara | United States | Unknown status |
| Springfield Clinic - First /ID# 272274 Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Retina Consultants - The Woodlands /ID# 255924 Coordinator of this site? Confirm its status | The Woodlands | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.