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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 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.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 146 participants |
| Start Date | 2020-08-25 |
| Est. Completion | 2027-02 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04514653
The ClinicalTrials.gov registry entry for NCT04514653 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 146 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 192-participant average among 9 other Neovascular Age-related Macular Degeneration (nAMD) trials with a reported enrollment target (24% lower). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
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 reports 18 study locations spanning 12 distinct geographic areas - top geographies include 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.
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