RGX-314 Gene Therapy Administered in the Suprachoroidal Space for Participants With Neovascular Age-Related Macular Degeneration (nAMD)

Incidence of overall and ocular adverse events (AEs) and serious adverse events (SAEs)

Incidence of overall and ocular adverse events (AEs) and serious adverse events (SAEs)

Time frame: 52 weeks

Vector shedding analysis in serum, urine, and tears

Evaluate the safety and tolerability of ABBV-RGX-314

Time frame: 52 Weeks

Proportion of participants who experience ocular inflammation following SCS ABBV-RGX-314 administration

To evaluate the incidences of ocular inflammation following SCS ABBV-RGX-314 administration

Time frame: 52 weeks

Mean change from baseline in choroidal neovascularization (CNV) lesion size and leakage area based on fluorescein angiography (FA)

To evaluate the effect of ABBV-RGX-314 on CNV lesion growth and leakage as measured by FA

Time frame: Up to Week 80

Mean change from baseline in BCVA based on ETDRS score

Evaluate the effect of ABBV-RGX-314 on BCVA

Time frame: Up to Week 80

Proportion of participants (1) gaining ≥ 15, ≥ 10, ≥ 5, or ≥ 0 letters; (2) losing ≥ 15, ≥ 10, ≥ 5, or > 0 letters (3) maintaining vision (not losing ≥ 15 letters) compared with baseline as per BCVA

To evaluate the effect of ABBV-RGX-314 on BCVA

Time frame: Up to Week 52

Mean change from baseline in CRT as measured by SD-OCT

To evaluate the effect of ABBV-RGX-314 on CRT, as measured by SD-OCT

Time frame: Up to Week 80

Mean supplemental anti-VEGF injection annualized rate in the ABBV-RGX-314 treatment arms

To assess the need for supplemental anti-VEGF therapy in participants who receive ABBV-RGX-314 treatment

Time frame: Up to Week 80

Proportion of participants who have a reduction of ≥ 50% and ≥ 75% in supplemental anti-VEGF- injection annualized rate

Proportion of participants who have a reduction of ≥ 50% and ≥ 75% in supplemental anti-VEGF- injection annualized rate through Week 40 and Week 52 compared with the prior 52 weeks preceding the first intravitreal ranibizumab injection received as part of the Screening Period (ABBV-RGX-314 administered participants)

Time frame: 52 Weeks

Proportion of participants with 0, ≤ 1, and ≤ 2 supplemental injections

To assess the need for supplemental anti-VEGF therapy in participants who receive ABBV-RGX-314 treatment

Time frame: Up to Week 80

Mean percent reduction in supplemental anti-VEGF injection annualized rate

To assess the need for supplemental anti-VEGF therapy in participants who receive ABBV-RGX-314 treatment

Time frame: Up to Week 80

Time from ABBV-RGX-314 administration to first supplemental anti-VEGF injection

To assess the need for supplemental anti-VEGF therapy in participants who receive ABBV-RGX-314 treatment

Time frame: 80 Weeks

Aqueous humor ABBV-RGX- 314 TP concentration over time

To evaluate the concentration of ABBV-RGX-314 TP in aqueous humor and serum

Time frame: 52 Weeks

Mean change from baseline in serum ABBV-RGX-314 TP concentration over time

To evaluate the concentration of ABBV-RGX-314 TP in aqueous humor and serum

Time frame: 80 Weeks