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

Enrolling by invitation · Phase 2

Conditions studied: Diabetic Retinopathy, DR

In brief

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.

Key facts

Study ID

NCT05296447

Run by

AbbVie

People needed

100

Starts

2022-04-04

Expected to finish

2031-06-01

Last updated by the study team

2026-08-05

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• None

Where it is running

• Retinal Research Institute, LLC — Phoenix, Arizona, United States
• California Retina Consultants — Bakersfield, California, United States
• Retina-Vitreous Associates Medical Group — Beverly Hills, California, United States
• Retinal Diagnostic Center — Los Angeles, 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
• Retina Consultants San Diego — Poway, California, United States
• California Retina Consultants CRC — Santa Barbara, California, United States
• Southeast Retina Center, PC — Augusta, Georgia, United States
• University Retina and Macula Associates, PC — Oak Forest, Illinois, 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
• New Jersey Retina — Teaneck, New Jersey, United States
• Vision Research Center Eye Associates of New Mexico — Albuquerque, New Mexico, United States
• Duke University — Durham, North Carolina, United States
• Mid Atlantic Retina — Philadelphia, Pennsylvania, United States
• Charles Retina Institute, P.C — Germantown, Tennessee, United States
• Austin Clinical Research — Austin, Texas, United States
• Retina Consultants of Texas — The Woodlands, Texas, United States

Full record on ClinicalTrials.gov

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