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 nAMD in which they received suprachoroidal space (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 up to 5 years after 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.
Study Type
OBSERVATIONAL
Enrollment
115
All subjects that previously received RGX-314 in a parent study
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
Northern California Retina Vitreous Associates Medical Group Inc
Mountain View, California, United States
Retina Consultants San Diego
Poway, California, United States
California Retina Consultants
Santa Barbara, California, United States
Southeast Retina Center PC
Augusta, Georgia, United States
Johns Hopkins University
Baltimore, Maryland, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States
Vitreoretinal Surgery PLLC
Edina, Minnesota, United States
...and 6 more locations
To evaluate the long-term safety of RGX-314
Incidences of ocular Adverse Events and Serious Adverse Events, and all Adverse Events of Special Interest
Time frame: 5 years inclusive of parent study
• To evaluate the persistence of effect of RGX-314 on best corrected visual acuity (BCVA)
• Mean change from baseline (ie, prior to RGX-314 administration in the parent study) in BCVA
Time frame: 5 years inclusive of parent study
• To evaluate the persistence of effect of RGX-314 on central retinal thickness (CRT), as measured by spectral domain-optical coherence tomography (SD-OCT)
• Mean change from baseline (ie, prior to RGX-314 administration in the parent study) in CRT as measured by SD-OCT
Time frame: 5 years inclusive of parent study
• To assess the need for supplemental anti-vascular endothelial growth factor (anti-VEGF) therapy
• Mean number of supplemental anti-VEGF injections based on chart review
Time frame: 5 years inclusive of parent study
• To assess the need of clinic visits for management of nAMD
• Mean number of retina specialist visits attended for nAMD based on chart review
Time frame: 5 years inclusive of parent study
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