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NCT04567550 · ClinicalTrials.gov registry record · Phase 2

RGX-314 Gene Therapy Administered in the Suprachoroidal Space for Participants With Diabetic Retinopathy (DR) With and Without Center Involved-Diabetic Macular Edema (CI-DME)

A Phase 2 study of Diabetic Retinopathy (DR) and Center-Involved Diabetic Macular Edema (CI-DME), sponsored by AbbVie.

Active
Registry status
Phase 2
Development phase
139
Enrollment target
20
Study locations

NCT04567550 is a Phase 2 study of Diabetic Retinopathy (DR) and Center-Involved Diabetic Macular Edema (CI-DME) that is active but no longer recruiting, run by AbbVie. The registered enrollment target is 139 participants, below the 482-participant average among 5 other Diabetic Retinopathy (DR) trials with a reported enrollment target (71% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT04567550, a Phase 2 study of Diabetic Retinopathy (DR) and Center-Involved Diabetic Macular Edema (CI-DME), is active but no longer recruiting, sponsored by AbbVie.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
139 participants
Enrollment target
20
Study locations

Study Summary

ABBV-RGX-314 is being developed as a novel, potential one-time gene therapy treatment for the treatment of Diabetic Retinopathy (DR) with and without Center-Involved Diabetic Macular Edema (CI-DME). DR is a chronic and progressive complication of diabetes mellitus. It is a sight-threatening disease characterized in the early stages by neuronal and vascular dysfunction in the retina, and later by neovascularization that leads to further deterioration of functional vision. Despite the availability of current treatments, diabetic retinopathy remains the leading cause of vision loss in working-age adults, those between the ages of 20 and 74. Existing treatment with anti-VEGF agents, although shown to be effective, are limited by short therapeutic half-lives, which then require frequent intravitreal injections over the patient's lifetime, resulting in increased risk of associated adverse events and significant treatment burden. Due to the burden of treatment, patients often do not closely adhere to treatment regimens and experience sub-optimal outcomes and a decline in vision.

Conditions Studied

Diabetic Retinopathy (DR) Center-Involved Diabetic Macular Edema (CI-DME)

Interventions

  • GENETIC ABBV-RGX-314 Dose 1
  • GENETIC ABBV-RGX-314 Dose 2
  • GENETIC ABBV-RGX-314 Dose 3
  • DRUG Topical Steroid
  • GENETIC ABBV-RGX-314 Dose 4

Study Locations (20)

California

  • California Retina Consultants - Bakersfield
  • Retina-Vitreous Associates Medical Group - Beverly Hills
  • Retinal Diagnostic Center - Campbell
  • Northern California Retina Vitreous Associates Medical Group, Inc. - Mountain View
  • California Eye Specialists Medical Group, Inc - Pasadena
  • Retinal Consultants San Diego - Poway
  • California Retina Consultants - Santa Barbara

Arizona

  • Retinal Research Institute, LLC - Phoenix
  • Barnet Dulaney Perkins Eye Center - Phoenix

Illinois

  • University Retina and Macula Associates, PC - Oak Forest
  • Springfield Clinic - Springfield

Maryland

  • Wilmer Eye Institute/Johns Hopkins University School of Medicine - Baltimore
  • Cumberland Valley Retina Consultants - Hagerstown

Georgia

  • Southeast Retina Center, PC - Augusta

Massachusetts

  • Ophthalmic Consultants of Boston - Boston

Nevada

  • Sierra Eye Associates - Reno

New Jersey

  • NJ Retina - Teaneck

Trial Details

FieldValue
Enrollment Target 139 participants
Start Date 2020-11-20
Est. Completion 2026-12
Phase Phase 2

Sponsor

AbbVie

526 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04567550

The ClinicalTrials.gov registry entry for NCT04567550 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 139 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 482-participant average among 5 other Diabetic Retinopathy (DR) trials with a reported enrollment target (71% lower). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Diabetic Retinopathy (DR) appearing as the primary indexed condition, and to 5 interventions - of which ABBV-RGX-314 Dose 1 is the first listed.

NCT04567550 reports 20 study locations spanning 11 distinct geographic areas - top geographies include California, Arizona, Illinois.

Frequently Asked Questions

What is clinical trial NCT04567550 about?

NCT04567550 is a clinical study titled "RGX-314 Gene Therapy Administered in the Suprachoroidal Space for Participants With Diabetic Retinopathy (DR) With and Without Center Involved-Diabetic Macular Edema (CI-DME)". ABBV-RGX-314 is being developed as a novel, potential one-time gene therapy treatment for the treatment of Diabetic Retinopathy (DR) with and without Center-Involved Diabetic Macular Edema (CI-DME). DR is a chronic and progressive complication of diabetes mellitus. It is a sight-threatening disease ...

What is the current status of trial NCT04567550?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 139 participants. The study started on 2020-11-20. Estimated completion is 2026-12.

What conditions does trial NCT04567550 study?

This clinical trial studies the following conditions: Diabetic Retinopathy (DR), Center-Involved Diabetic Macular Edema (CI-DME).

What interventions are being tested in trial NCT04567550?

The interventions under investigation include: ABBV-RGX-314 Dose 1 (GENETIC), ABBV-RGX-314 Dose 2 (GENETIC), ABBV-RGX-314 Dose 3 (GENETIC), Topical Steroid (DRUG), ABBV-RGX-314 Dose 4 (GENETIC).

Who is sponsoring clinical trial NCT04567550?

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

Where is trial NCT04567550 being conducted?

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

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.