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NCT04514653 · ClinicalTrials.gov registry record · Phase 2

RGX-314 Gene Therapy Administered in the Suprachoroidal Space for Participants With Neovascular Age-Related Macular Degeneration (nAMD)

A Phase 2 study of Neovascular Age-related Macular Degeneration (nAMD), sponsored by AbbVie.

Active
Registry status
Phase 2
Development phase
146
Enrollment target
18
Study locations

NCT04514653: Active Phase 2 study of Neovascular Age-related Macular Degeneration (nAMD), sponsored by AbbVie.

NCT04514653 is a Phase 2 study of Neovascular Age-related Macular Degeneration (nAMD) that is active but no longer recruiting, run by AbbVie. The registered enrollment target is 146 participants, below the 192-participant average among 9 other Neovascular Age-related Macular Degeneration (nAMD) trials with a reported enrollment target (24% lower). The trial reports 18 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04514653, a Phase 2 study of Neovascular Age-related Macular Degeneration (nAMD), is active but no longer recruiting, sponsored by AbbVie.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
146 participants
Enrollment target
18
Study locations

Study Summary

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.

Primary Outcome

The scale used is the early treatment diabetic retinopathy study (ETDRS) letter score from 0-100 and higher score being better vision.

Conditions Studied

Neovascular Age-related Macular Degeneration (nAMD)

Interventions

  • GENETIC ABBV-RGX-314 Dose 1
  • GENETIC ABBV-RGX-314 Dose 2
  • BIOLOGICAL Ranibizumab
  • GENETIC ABBV-RGX-314 Dose 3
  • DRUG Local Steroid

Study Locations (18)

California

  • California Retina Consultants - Bakersfield /ID# 255910 - Bakersfield
  • Retina Vitreous Assoc Med Grp /ID# 255921 - Beverly Hills
  • Retinal Diagnostic Center /ID# 272275 - Campbell
  • Northern California Retina Vitreous Associates Medical Group, Inc /ID# 255920 - Mountain View
  • Retina Consultants of San Diego /ID# 255911 - Poway
  • California Retina Consultants - Santa Barbara /ID# 255923 - Santa Barbara

Tennessee

  • Charles Retina Institute /ID# 255922 - Germantown
  • Tennessee Retina - Nashville /ID# 255918 - Nashville

Arizona

  • Retinal Research Institute /ID# 255925 - Phoenix

Georgia

  • Southeast Retina Center /ID# 255912 - Augusta

Illinois

  • Springfield Clinic - First /ID# 272274 - Springfield

Maryland

  • Johns Hopkins Hospital /ID# 255919 - Baltimore

Massachusetts

  • Ophthalmic Consultants of Boston /ID# 255917 - Boston

Nevada

  • Sierra Eye Associates /ID# 255908 - Reno

Trial Details

FieldValue
Enrollment Target 146 participants
Start Date 2020-08-25
Est. Completion 2027-02
Phase Phase 2
AbbVie

526 total trials

What the registry record for NCT04514653 still lists

NCT04514653 is an interventional study that assigns participants to a tested intervention. The registered 146 participants enrollment target is mid-sized for trials with a published cap, below the 192-participant average among 9 other Neovascular Age-related Macular Degeneration (nAMD) trials with a reported enrollment target (24% lower).

The record links to 1 condition, with Neovascular Age-related Macular Degeneration (nAMD) appearing as the primary indexed condition, and to 5 interventions - of which ABBV-RGX-314 Dose 1 is the first listed.

NCT04514653 lists 18 locations in 12 states (California, Tennessee, Arizona).

Frequently Asked Questions

What is clinical trial NCT04514653 about?

NCT04514653 is a clinical study titled "RGX-314 Gene Therapy Administered in the Suprachoroidal Space for Participants With Neovascular Age-Related Macular Degeneration (nAMD)". 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 treatmen...

What is the current status of trial NCT04514653?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 146 participants. The study started on 2020-08-25. Estimated completion is 2027-02.

What conditions does trial NCT04514653 study?

This clinical trial studies the following conditions: Neovascular Age-related Macular Degeneration (nAMD).

What interventions are being tested in trial NCT04514653?

The interventions under investigation include: ABBV-RGX-314 Dose 1 (GENETIC), ABBV-RGX-314 Dose 2 (GENETIC), Ranibizumab (BIOLOGICAL), ABBV-RGX-314 Dose 3 (GENETIC), Local Steroid (DRUG).

Who is sponsoring clinical trial NCT04514653?

This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04514653 being conducted?

This trial has 18 study locations across Arizona, California, Georgia, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Neovascular Age-related Macular Degeneration (nAMD)

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04514653's enrollment target sits among peer trials

146 6th of 9 higher than 4 of 9 other Neovascular Age-related Macular Degeneration (nAMD) trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Neovascular Age-related Macular Degeneration (nAMD) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT04514653, the US trial registry maintained by the National Library of Medicine. NCT04514653 (mid enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.