The was a 64-week randomized, double-masked, multi-center, active-controlled, two-arm study in patients with neovascular age related macular degeneration (nAMD) who have not previously received anti- vascular endothelial growth factor (VEGF) treatment.~At the baseline Visit, subjects who met the eligibility criteria were randomized in a 1:1 ratio to receive either: -Brolucizumab 6 mg: 3 × 4-week injections and one 8-week injection, followed by Treat-to- Control treatment from Week 16 up to Week 60/62~-Aflibercept 2 mg: 3 × 4-week injections and one 8-week injection, followed by Treat-to-Control treatment from Week 16 up to Week 60/62.~For all subjects, the last potential study treatment was at the Week 60 visit (or at the Week 62 visit for subjects whose actual treatment interval would require a treatment at Week 62). The initiation phase starts on Day 1 and ends on Week 16. Treat to Control regimen starts on Week 16 until end of treatment (Week 60/62).~In both treatment arms, treatment intervals after the initiation phase were either 8 weeks, 12 weeks, or 16 weeks. Per the original protocol, if it was determined that a patient required more frequent injections than q8w, he/she would be moved to a q4w treatment interval. However, this option was removed per Protocol amendment 02, after which, dosing intervals shorter than q8w were not permitted.~At the investigator's discretion, an inspection visit 6 weeks after the last injection could be performed when the injection interval was extended from 4 weeks to 8 weeks, i.e., after the 3rd injection at Week 8. If there was no disease activity in the study eye at the inspection visit, as assessed by the masked investigator, no treatment should be administered and the next visit and injection should take place 2 weeks later, i.e., 8 weeks after the previous study treatment. If disease activity was observed by the masked investigator in the study eye at the inspection visit at Week 14, the study treatment should be administered by the unmasked investigator, and the subject should be discontinued from further study treatment at the next visit. Inspection visits 10 weeks and 14 weeks after the last injection could have been performed when the injection interval was extended from 8 weeks to 12 weeks, and from 12 weeks to 16 weeks, respectively.
The was a 64-week randomized, double-masked, multi-center, active-controlled, two-arm study in patients with neovascular age related macular degeneration (nAMD) who have not previously received anti- vascular endothelial growth factor (VEGF) treatment.