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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 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- GENETIC ABBV-RGX-314 Dose 1
- GENETIC ABBV-RGX-314 Dose 2
- GENETIC ABBV-RGX-314 Dose 3
- DRUG Topical Steroid
- GENETIC ABBV-RGX-314 Dose 4
Study Locations (20)
California
- California Retina Consultants — Bakersfield
- Retina-Vitreous Associates Medical Group — Beverly Hills
- Retinal Diagnostic Center — Campbell
- Northern California Retina Vitreous Associates Medical Group, Inc. — Mountain View
- California Eye Specialists Medical Group, Inc — Pasadena
- Retinal Consultants San Diego — Poway
- California Retina Consultants — Santa Barbara
Arizona
- Retinal Research Institute, LLC — Phoenix
- Barnet Dulaney Perkins Eye Center — Phoenix
Illinois
- University Retina and Macula Associates, PC — Oak Forest
- Springfield Clinic — Springfield
Maryland
- Wilmer Eye Institute/Johns Hopkins University School of Medicine — Baltimore
- Cumberland Valley Retina Consultants — Hagerstown
Georgia
- Southeast Retina Center, PC — Augusta
Massachusetts
- Ophthalmic Consultants of Boston — Boston
Nevada
- Sierra Eye Associates — Reno
New Jersey
- NJ Retina — Teaneck
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 139 participants |
| Start Date | 2020-11-20 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04567550
The ClinicalTrials.gov registry entry for NCT04567550 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 139 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Diabetic Retinopathy (DR) appearing as the primary indexed condition, and to 5 interventions — of which ABBV-RGX-314 Dose 1 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04567550 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Arizona, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04567550 about?
NCT04567550 is a clinical study titled "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)". 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 ...
What is the current status of trial NCT04567550?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 139 participants. The study started on 2020-11-20. Estimated completion is 2026-12.
What conditions does trial NCT04567550 study?
This clinical trial studies the following conditions: Diabetic Retinopathy (DR), Center-Involved Diabetic Macular Edema (CI-DME). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04567550?
The interventions under investigation include: ABBV-RGX-314 Dose 1 (GENETIC), ABBV-RGX-314 Dose 2 (GENETIC), ABBV-RGX-314 Dose 3 (GENETIC), Topical Steroid (DRUG), ABBV-RGX-314 Dose 4 (GENETIC). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04567550?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04567550 being conducted?
This trial has 20 study locations across Arizona, California, Georgia, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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