RGX-314 Gene Therapy for Diabetic Retinopathy
(ALTITUDE® Trial)

Recruiting in Palo Alto (17 mi)

+45 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: REGENXBIO, Inc.

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

This trial is for adults aged 25-89 with diabetic retinopathy, who have good vision (20/40 or better) and can delay other treatments like PRP or anti-VEGF injections for at least 6 months. It's not for those with active macular edema, prior eye surgeries, potential pregnancy, or retinal issues not caused by diabetes.

Inclusion Criteria

Your vision in the study eye is 20/40 or better.

I am 25-89 years old with diabetic retinopathy and can delay certain treatments for 6 months.

It's okay if you have had a certain eye condition in the past in the eye being studied.

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Exclusion Criteria

I have active diabetic macular edema.

I have had PRP or retinal laser treatment in my study eye.

My eye condition is not due to diabetic retinopathy.

See 3 more

Treatment Details

Interventions

RGX-314 (Gene Therapy)

Trial OverviewThe study tests RGX-314 gene therapy as a one-time treatment for diabetic retinopathy. Participants will receive different doses of RGX-314 administered into the suprachoroidal space of the eye to see if it can improve their condition without frequent treatments.

Participant Groups

6Treatment groups

Experimental Treatment

Active Control

Group I: Part 2: ABBV-RGX-314 Treatment Arm (Dose 4) and Topical SteroidExperimental Treatment2 Interventions

ABBV-RGX-314 Dose 4 and Topical Steroid

Group II: Part 1: ABBV-RGX-314 Treatment Arm (Dose 3) and Topical SteroidExperimental Treatment2 Interventions

ABBV-RGX-314 Dose 3 and Topical Steroid

Group III: Part 1: ABBV-RGX-314 Treatment Arm (Dose 2)Experimental Treatment1 Intervention

ABBV-RGX-314 Dose 2

Group IV: Part 1: ABBV-RGX-314 Treatment Arm (Dose 1)Experimental Treatment1 Intervention

ABBV-RGX-314 Dose 1