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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)

NCT04567550 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 139

Last updated 2025-09-17

No results posted yet for this 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

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

Interventions

GENETIC

ABBV-RGX-314 Dose 1

AAV8 vector containing a transgene for anti-VEGF fab (Dose 1)

GENETIC

ABBV-RGX-314 Dose 2

AAV8 vector containing a transgene for anti-VEGF fab (Dose 2)

GENETIC

ABBV-RGX-314 Dose 3

AAV8 vector containing a transgene for anti-VEGF fab (Dose 3)

DRUG

Topical Steroid

Topical Steroid

GENETIC

ABBV-RGX-314 Dose 4

AAV8 vector containing a transgene for anti-VEGF fab (Dose 4)

BIOLOGICAL

Aflibercept

Aflibercept

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-20
Primary Completion
2026-06-30
Completion
2026-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04567550 on ClinicalTrials.gov