Neovascular age-related macular degeneration
Conditions
Brief summary
Mean change from baseline in BCVA to Week 54 based on the ETDRS score (noninferiority to the active control).
Detailed description
Proportion of participants with ≤2 supplemental anti-VEGF injections through Week 54 (ABBV-RGX-314 randomized participants), Proportion of participants with no supplemental anti-VEGF injections through Week 54 (ABBV-RGX-314 randomized participants), Percent reduction in anti-VEGF injection annualized rate through Week 54 compared with the prior yeara (ABBV-RGX-314 randomized participants), Mean change from baseline in BCVA to Week 54 based on the ETDRS score (superiority to the active control)
Interventions
DRUGABBV-RGX-314 or RGX-314
Sponsors
Abbvie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline in BCVA to Week 54 based on the ETDRS score (noninferiority to the active control). | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants with ≤2 supplemental anti-VEGF injections through Week 54 (ABBV-RGX-314 randomized participants), Proportion of participants with no supplemental anti-VEGF injections through Week 54 (ABBV-RGX-314 randomized participants), Percent reduction in anti-VEGF injection annualized rate through Week 54 compared with the prior yeara (ABBV-RGX-314 randomized participants), Mean change from baseline in BCVA to Week 54 based on the ETDRS score (superiority to the active control) | — |
Countries
France, Germany, Hungary, Italy, Spain
Outcome results
None listed