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)

Conditions

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

Eligibility Criteria

Sex

ALL

Age

25 Years - 89 Years

Healthy Volunteers

Not accepted

Interventions

• ABBV-RGX-314 Dose 1 — GENETIC
  AAV8 vector containing a transgene for anti-VEGF fab (Dose 1)
• ABBV-RGX-314 Dose 2 — GENETIC
  AAV8 vector containing a transgene for anti-VEGF fab (Dose 2)
• ABBV-RGX-314 Dose 3 — GENETIC
  AAV8 vector containing a transgene for anti-VEGF fab (Dose 3)
• Topical Steroid — DRUG
  Topical Steroid
• ABBV-RGX-314 Dose 4 — GENETIC
  AAV8 vector containing a transgene for anti-VEGF fab (Dose 4)
• Aflibercept — BIOLOGICAL
  Aflibercept

Study Details

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.

Key Dates

Start date

Nov 20, 2020

Status verified

Sep 2025

Primary completion

Jun 30, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

139 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• No Intervention: Part 1: Observation Control Arm
  Observation Control
• Experimental: Part 1: ABBV-RGX-314 Treatment Arm (Dose 1)
  ABBV-RGX-314 Dose 1
• Experimental: Part 1: ABBV-RGX-314 Treatment Arm (Dose 2)
  ABBV-RGX-314 Dose 2
• Experimental: Part 1: ABBV-RGX-314 Treatment Arm (Dose 3) and Topical Steroid
  ABBV-RGX-314 Dose 3 and Topical Steroid
• Experimental: Part 2: ABBV-RGX-314 Treatment Arm (Dose 4) and Topical Steroid
  ABBV-RGX-314 Dose 4 and Topical Steroid
• Active Comparator: Part 2: Aflibercept Control
  Control treatment arm

Primary Outcome Measure

Part 1: Proportion of participants achieving a 2-step or greater improvement in DR in the study eye per the ETDRS-DRSS on 4 widefield digital stereoscopic fundus photography at Week 48 [ Time Frame: At Week 48 ]

Locations (25)

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