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NCT04704921 · ClinicalTrials.gov registry record · Phase 2

Pivotal 1 Study of ABBV-RGX-314 (Also Known as RGX-314) Gene Therapy Administered Via Subretinal Delivery One Time in Participants With nAMD

A Phase 2 study of Neovascular Age-related Macular Degeneration and Wet Age-related Macular Degeneration, sponsored by AbbVie.

Recruiting
Registry status
Phase 2
Development phase
630
Enrollment target
20
Study locations

NCT04704921 is a Phase 2 study of Neovascular Age-related Macular Degeneration and Wet Age-related Macular Degeneration that is actively recruiting participants, run by AbbVie. The registered enrollment target is 630 participants, above the 389-participant average among 33 other Neovascular Age-related Macular Degeneration trials with a reported enrollment target (62% higher). The trial reports 20 study locations across 4 states.

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The verdict

NCT04704921, a Phase 2 study of Neovascular Age-related Macular Degeneration and Wet Age-related Macular Degeneration, is actively recruiting participants, sponsored by AbbVie.

RECRUITING
Registry status
Phase 2
Development phase
630 participants
Enrollment target
20
Study locations

Study Summary

ABBV-RGX-314 (also known as RGX-314) is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD or nAMD). Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina. Wet AMD is a significant cause of vision loss in the United States, Europe and Japan, with up to 2 million people living with wet AMD in these geographies alone. Current anti-vascular endothelial growth factor (anti-VEGF) therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to maintain or prevent progression of vision loss in the majority of patients. These therapies, however, require life-long intraocular injections, typically repeated every 4 to 16 weeks in frequency, to maintain efficacy. Due to the burden of these treatments, patients often experience a decline in vision with reduced frequency of treatment over time.

Conditions Studied

Neovascular Age-related Macular Degeneration Wet Age-related Macular Degeneration Choroidal Neovascularization AMD wAMD Wet AMD nAMD CNV Neovascular AMD

Interventions

  • GENETIC ABBV-RGX-314
  • BIOLOGICAL Ranibizumab (LUCENTIS®)

Study Locations (20)

California

  • Retina Vitreous Assoc Med Grp /ID# 256299 - Beverly Hills
  • Retinal Diagnostic Center /ID# 256137 - Campbell
  • The Retina Partners - Encino /ID# 256054 - Encino
  • Retina Consultants of Orange County /ID# 256152 - Fullerton
  • Salehi Retina Institute /ID# 263485 - Huntington Beach
  • UC Irvine/Gavin Herbert Eye Institute /ID# 256145 - Irvine
  • Northern California Retina Vitreous Associates Medical Group, Inc /ID# 256298 - Mountain View
  • UCLA Doheny Eye Center /ID# 256120 - Pasadena
  • California Eye Specialists Medical Group Inc. /ID# 256079 - Pasadena
  • Retina Consultants of San Diego /ID# 256021 - Poway
  • Retinal Consultants Medical Group /ID# 256047 - Sacramento
  • West Coast Retina /ID# 256448 - San Francisco
  • University of California, San Francisco /ID# 256130 - San Francisco
  • Orange County Retina Medical Group /ID# 256073 - Santa Ana
  • California Retina Consultants - Santa Barbara /ID# 256017 - Santa Barbara

Arizona

  • Retinal Research Institute /ID# 256019 - Phoenix
  • Barnet Dulaney Perkins Eye Center - Sun City /ID# 256055 - Sun City

Colorado

  • Retina Consultants of Southern Colorado /ID# 256069 - Colorado Springs
  • Southwest Retina Research Center /ID# 256136 - Durango

Arkansas

  • University of Arkansas for Medical Sciences /ID# 271290 - Little Rock

Trial Details

FieldValue
Enrollment Target 630 participants
Start Date 2020-12-29
Est. Completion 2027-11
Phase Phase 2

Sponsor

AbbVie

526 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04704921

The ClinicalTrials.gov registry entry for NCT04704921 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 630 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 389-participant average among 33 other Neovascular Age-related Macular Degeneration trials with a reported enrollment target (62% higher). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.

The record links to 9 conditions, with Neovascular Age-related Macular Degeneration appearing as the primary indexed condition, and to 2 interventions - of which ABBV-RGX-314 is the first listed.

NCT04704921 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Arizona, Colorado.

Frequently Asked Questions

What is clinical trial NCT04704921 about?

NCT04704921 is a clinical study titled "Pivotal 1 Study of ABBV-RGX-314 (Also Known as RGX-314) Gene Therapy Administered Via Subretinal Delivery One Time in Participants With nAMD". ABBV-RGX-314 (also known as RGX-314) is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD or nAMD). Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina. Wet AMD is a signific...

What is the current status of trial NCT04704921?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 630 participants. The study started on 2020-12-29. Estimated completion is 2027-11.

What conditions does trial NCT04704921 study?

This clinical trial studies the following conditions: Neovascular Age-related Macular Degeneration, Wet Age-related Macular Degeneration, Choroidal Neovascularization, AMD, wAMD.

What interventions are being tested in trial NCT04704921?

The interventions under investigation include: ABBV-RGX-314 (GENETIC), Ranibizumab (LUCENTIS®) (BIOLOGICAL).

Who is sponsoring clinical trial NCT04704921?

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

Where is trial NCT04704921 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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