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)

Running, not enrolling · Phase 2

Conditions studied: Diabetic Retinopathy (DR), Center-Involved Diabetic Macular Edema (CI-DME)

In brief

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 facts

Study ID

NCT04567550

Run by

AbbVie

People needed

139

Starts

2020-11-20

Expected to finish

2026-12-01

Last updated by the study team

2025-09-17

Who can join

Age: 25 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients 25-89 years of age with a diabetic retinopathy (DR) diagnosis of nonproliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy (PDR) secondary to diabetes mellitus Type 1 or 2 for which PRP or anti-VEGF injections can be safely deferred for at least 6 months
• HbA1c < 12%.
• Best corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better).
• Prior history of CI-DME in the study eye is acceptable.
• Must be willing and able to provide written, signed informed consent.

You may not qualify if…

• Neovascularization in the study eye from a cause other than DR.
• Presence of any active CI-DME.
• Active or history of retinal detachment in the study eye.
• Any evidence or documented history of PRP or retinal laser in the study eye.
• Patients who had a prior vitrectomy surgery.
• Women of childbearing potential.
• Part 2 (DR with CI-DME):
• Inclusion Criteria:
• Patients 25-89 years of age with diabetic retinopathy secondary to diabetes mellitus Type 1 or 2.
• HbA1c < 12%
• Macular thickening secondary to DME involving the center of the fovea, CST on SD-OCT (≥ 325 μm)
• Best corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye of 78-25 letters (approximate Snellen equivalent of 20/32 to 20/320)
• Participants must have demonstrated a meaningful response to anti-VEGF therapy.
• Must be willing and able to provide written, signed informed consent
• Exclusion Criteria:
• Neovascularization in the study eye from a cause other than DR.
• Active or history of retinal detachment in the study eye.
• Any evidence or documented history of PRP or retinal laser in the study eye.
• Patients who had a prior vitrectomy surgery.
• Women of childbearing potential.
• Note: Other inclusions/exclusions criteria apply.

Where it is running

• Retinal Research Institute, LLC — Phoenix, Arizona, United States
• Barnet Dulaney Perkins Eye Center — Phoenix, Arizona, United States
• California Retina Consultants — Bakersfield, California, United States
• Retina-Vitreous Associates Medical Group — Beverly Hills, California, United States
• Retinal Diagnostic Center — Campbell, California, United States
• Northern California Retina Vitreous Associates Medical Group, Inc. — Mountain View, California, United States
• California Eye Specialists Medical Group, Inc — Pasadena, California, United States
• Retinal Consultants San Diego — Poway, California, United States
• California Retina Consultants — Santa Barbara, California, United States
• Southeast Retina Center, PC — Augusta, Georgia, United States
• University Retina and Macula Associates, PC — Oak Forest, Illinois, United States
• Springfield Clinic — Springfield, Illinois, United States
• Wilmer Eye Institute/Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
• Cumberland Valley Retina Consultants — Hagerstown, Maryland, United States
• Ophthalmic Consultants of Boston — Boston, Massachusetts, United States
• Sierra Eye Associates — Reno, Nevada, United States
• NJ Retina — Teaneck, New Jersey, United States
• Vision Research Center Eye Associates of New Mexico — Albuquerque, New Mexico, United States
• Duke University Eye Center — Durham, North Carolina, United States
• Mid Atlantic Retina — Philadelphia, Pennsylvania, United States
• Charles Retina Institute, P.C. — Germantown, Tennessee, United States
• Retina Research Institute of Texas, LLC — Abilene, Texas, United States
• Austin Clinical Research, LLC — Austin, Texas, United States
• Star Retina — Burleson, Texas, United States
• Retinal Consultants of Texas — The Woodlands, Texas, United States

Full record on ClinicalTrials.gov

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