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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
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

Full criteria on ClinicalTrials.gov

Sites (18)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Eye Associates of New Mexico /ID# 255915
Coordinator of this site? Confirm its status
AlbuquerqueUnited StatesUnknown status
Southeast Retina Center /ID# 255912
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AugustaUnited StatesUnknown status
California Retina Consultants - Bakersfield /ID# 255910
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BakersfieldUnited StatesUnknown status
Johns Hopkins Hospital /ID# 255919
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BaltimoreUnited StatesUnknown status
Retina Vitreous Assoc Med Grp /ID# 255921
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Beverly HillsUnited StatesUnknown status
Ophthalmic Consultants of Boston /ID# 255917
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BostonUnited StatesUnknown status
Retinal Diagnostic Center /ID# 272275
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CampbellUnited StatesUnknown status
Duke University Medical Center /ID# 267646
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DurhamUnited StatesUnknown status
Charles Retina Institute /ID# 255922
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GermantownUnited StatesUnknown status
Northern California Retina Vitreous Associates Medical Group, Inc /ID# 255920
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Mountain ViewUnited StatesUnknown status
Tennessee Retina - Nashville /ID# 255918
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NashvilleUnited StatesUnknown status
Mid Atlantic Retina /ID# 255906
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PhiladelphiaUnited StatesUnknown status
Retinal Research Institute /ID# 255925
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PhoenixUnited StatesUnknown status
Retina Consultants of San Diego /ID# 255911
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PowayUnited StatesUnknown status
Sierra Eye Associates /ID# 255908
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RenoUnited StatesUnknown status
California Retina Consultants - Santa Barbara /ID# 255923
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Santa BarbaraUnited StatesUnknown status
Springfield Clinic - First /ID# 272274
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SpringfieldUnited StatesUnknown status
Retina Consultants - The Woodlands /ID# 255924
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The WoodlandsUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.