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)

Description

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)

Study Overview

Study Details

Study overview

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.

A Phase 2, Randomized, Controlled, Dose-escalation Study to Evaluate the Efficacy, Safety, and Tolerability of RGX-314 Gene Therapy Delivered Via a Single Suprachoroidal Space (SCS) Injections in Participants With Diabetic Retinopathy (DR) With and Without Center Involved-Diabetic Macular Edema (CI-DME)(ALTITUDE)

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)

Condition
Diabetic Retinopathy (DR)
Intervention / Treatment

-

Contacts and Locations

Phoenix

Retinal Research Institute, LLC, Phoenix, Arizona, United States, 85014

Phoenix

Barnet Dulaney Perkins Eye Center, Phoenix, Arizona, United States, 85016

Bakersfield

California Retina Consultants, Bakersfield, California, United States, 93309

Beverly Hills

Retina-Vitreous Associates Medical Group, Beverly Hills, California, United States, 90017

Campbell

Retinal Diagnostic Center, Campbell, California, United States, 95008

Mountain View

Northern California Retina Vitreous Associates Medical Group, Inc., Mountain View, California, United States, 94040

Pasadena

California Eye Specialists Medical Group, Inc, Pasadena, California, United States, 91107

Poway

Retinal Consultants San Diego, Poway, California, United States, 92064

Santa Barbara

California Retina Consultants, Santa Barbara, California, United States, 93103

Augusta

Southeast Retina Center, PC, Augusta, Georgia, United States, 30909

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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.

Ages Eligible for Study

25 Years to 89 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AbbVie,

Study Record Dates

2026-09