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ENROLLING BY INVITATION
NCT05296447

Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With Diabetic Retinopathy

Sponsor: AbbVie

View on ClinicalTrials.gov

Summary

This is a prospective, observational study designed to evaluate the long-term safety and efficacy of RGX-314. Eligible participants are those who were previously enrolled in a clinical study of DR without center involved-diabetic macular edema (CI-DME) in which they received SCS administration of 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-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 RGX-314 administration in the parent study.

Official title: A Long-term Follow-Up Study to Evaluate the Safety and Efficacy of Suprachoroidal Administration of RGX-314 for Diabetic Retinopathy Without Center Involved-Diabetic Macular Edema

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2022-04-04

Completion Date

2028-05

Last Updated

2025-06-18

Healthy Volunteers

No

Interventions

OTHER

No Intervention

All subjects that previously received RGX-314 in a parent study

Locations (19)

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

American Institute of Research

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

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

Retinovitreous Associates, LTD

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