Neovascular Age-Related Macular Degeneration (nAMD)
Conditions
Keywords
Gene Therapy, AMD, wet AMD, wAMD, nAMD
Brief 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 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.
Interventions
DRUGStandard of Care
Standard of Care
DRUGRanibizumab
Injection
Sponsors
AbbVie
REGENXBIO Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Must provide written, signed informed consent for this study. 2. Must have been enrolled in a previous clinical study of ABBV-RGX-314 in the treatment of nAMD and must have received an SCS injection of ABBV-RGX-314 in that study. 3. Must be willing and able to comply with all study procedures.
Exclusion criteria
1\. None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidences of ocular Adverse Events and any Serious Adverse Events | 5 years inclusive of parent study | To evaluate the long-term safety of ABBV-RGX-314 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidences of non-ocular Adverse Events and any Adverse Events of Special Interest | 5 years inclusive of parent study | To evaluate the long-term safety of ABBV-RGX-314 |
| 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 | 5 years inclusive of parent study | To evaluate the persistence of effect of ABBV-RGX-314 on best corrected visual acuity (BCVA) |
| 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 | 5 years inclusive of parent study | 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) |
| Mean number of supplemental anti-VEGF injections through years 2, 3, 4 and 5 | 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 in years 2, 3, 4, and 5 | 5 years inclusive of parent study | To assess the need for supplemental anti-vascular endothelial growth factor (anti-VEGF) therapy |
| Mean supplemental anti-VEGF injection annualized rate through years 2, 3, 4, and 5 | 5 years inclusive of parent study | To assess the need for supplemental anti-vascular endothelial growth factor (anti-VEGF) therapy |
| Mean supplemental anti-VEGF injection annualized rate in years 2, 3, 4, and 5 | 5 years inclusive of parent study | To assess the need for supplemental anti-vascular endothelial growth factor (anti-VEGF) therapy |
| Mean number of retina specialist visits attended for nAMD through years 2, 3, 4, and 5 | 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 in years 2, 3, 4, and 5 | 5 years inclusive of parent study | To assess the need of clinic visits for management of nAMD |
Countries
United States
Outcome results
None listed