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Clinical Trials in the USA / NCT05296447
Enrolling by invitation Phase 2

Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy

NCT05296447 · tracked via the Priya Life Science USA tracker
Sponsor
AbbVie
Phase
Phase 2
Started
2022-04-04
Last updated
2026-08-05

Condition(s) studied

Diabetic Retinopathy, DR

Investigational drug(s) / intervention(s)

Standard of CareAflibercept →

Standard of Care: Standard of Care

Aflibercept: Injection

Study summary

This is a prospective study designed to evaluate the long-term safety and efficacy of ABBV-RGX-314. Eligible participants are those who were previously enrolled in a clinical study of DR with and without center involved-diabetic macular edema (CI-DME) in which they received suprachoroidal space (SCS) administration of ABBV-RGX-314. Enrollment of each participant in the current study should occur after the participant has completed either the end of study or early discontinuation visit in the previous (parent) clinical study. Participants will be followed for a total of 5 years post-ABBV-RGX-314 administration (inclusive of the parent study). As such, the total study duration for each participant may vary depending on when they enroll in the current study following ABBV-RGX-314 administration in the parent study.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Must provide written, signed informed consent for this study * Must have been enrolled in a previous clinical study of ABBV-RGX-314 for the treatment of DR with or without CI-DME and must have received an SCS injection of ABBV-RGX-314 in that study * Must be willing and able to comply with all study procedures Exclusion Criteria: * None

Primary outcome measure(s)

  • Incidence of ocular adverse events (AEs) and any serious adverse events (SAEs) — 5 years inclusive of the parent study
    To evaluate the long-term safety of ABBV-RGX-314

Trial sites (20)

FacilityCityRegionStatus
Retinal Research Institute, LLC Phoenix Arizona
California Retina Consultants Bakersfield California
Retina-Vitreous Associates Medical Group Beverly Hills California
Retinal Diagnostic Center Los Angeles California
Northern California Retina Vitreous Associates Medical Group Inc Mountain View California
California Eye Specialists Medical Group, Inc Pasadena California
Retina Consultants San Diego Poway California
California Retina Consultants CRC Santa Barbara California
Southeast Retina Center, PC Augusta Georgia
University Retina and Macula Associates, PC Oak Forest Illinois
Cumberland Valley Retina Consultants Hagerstown Maryland
Ophthalmic Consultants of Boston Boston Massachusetts
Sierra eye Associates Reno Nevada
New Jersey Retina Teaneck New Jersey
Vision Research Center Eye Associates of New Mexico Albuquerque New Mexico
Duke University Durham North Carolina
Mid Atlantic Retina Philadelphia Pennsylvania
Charles Retina Institute, P.C Germantown Tennessee
Austin Clinical Research Austin Texas
Retina Consultants of Texas The Woodlands Texas

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05296447 on ClinicalTrials.gov ↗ ← All trials in the USA