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Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Sponsor: AbbVie
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.
Official title: A Long-term Follow-Up Study to Evaluate the Safety and Efficacy of Suprachoroidal Administration of RGX-314 for Diabetic Retinopathy With and Without Center Involved-Diabetic Macular Edema
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2022-04-04
Completion Date
2031-06
Last Updated
2026-08-05
Healthy Volunteers
No
Conditions
Interventions
Standard of Care
Standard of Care
Aflibercept
Injection
Locations (20)
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