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 nAMD 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 up to 5 years after 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
116
Standard of Care
Injection
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
Incidences of ocular Adverse Events and any Serious Adverse Events
To evaluate the long-term safety of ABBV-RGX-314
Time frame: 5 years inclusive of parent study
Incidences of non-ocular Adverse Events and any Adverse Events of Special Interest
To evaluate the long-term safety of ABBV-RGX-314
Time frame: 5 years inclusive of parent study
Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in BCVA based on ETDRS score in the study eye at assessed timepoints
To evaluate the persistence of effect of ABBV-RGX-314 on best corrected visual acuity (BCVA)
Time frame: 5 years inclusive of parent study
Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in CRT as measured by SD-OCT in the study eye at assessed timepoints
To evaluate the persistence of effect of ABBV-RGX-314 on central retinal thickness (CRT), as measured by spectral domain-optical coherence tomography (SD-OCT)
Time frame: 5 years inclusive of parent study
Mean number of supplemental anti-VEGF injections through years 2, 3, 4 and 5
To assess the need for supplemental anti-vascular endothelial growth factor (anti-VEGF) therapy
Time frame: 5 years inclusive of parent study
Mean number of supplemental anti-VEGF injections in years 2, 3, 4, and 5
To assess the need for supplemental anti-vascular endothelial growth factor (anti-VEGF) therapy
Time frame: 5 years inclusive of parent study
Mean supplemental anti-VEGF injection annualized rate through years 2, 3, 4, and 5
To assess the need for supplemental anti-vascular endothelial growth factor (anti-VEGF) therapy
Time frame: 5 years inclusive of parent study
Mean supplemental anti-VEGF injection annualized rate in years 2, 3, 4, and 5
To assess the need for supplemental anti-vascular endothelial growth factor (anti-VEGF) therapy
Time frame: 5 years inclusive of parent study
Mean number of retina specialist visits attended for nAMD through years 2, 3, 4, and 5
To assess the need of clinic visits for management of nAMD
Time frame: 5 years inclusive of parent study
Mean number of retina specialist visits attended for nAMD in years 2, 3, 4, and 5
To assess the need of clinic visits for management of nAMD
Time frame: 5 years inclusive of parent study
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