Post-Marketing Safety and Effectiveness Study of Brolucizumab Beovu Injection and Prefilled Syringe for Neovascular Age-related Macular Degeneration

What this Trial Is About

This research aims to gather safety and effectiveness information for patients with neovascular age-related macular degeneration nAMD who are prescribed brolucizumab. It is an open-label, multicenter, single-arm, observational post-marketing surveillance study conducted by Novartis Pharmaceuticals to monitor patients receiving this treatment in real-world settings. Participants prescribed brolucizumab according to approved local guidelines will be enrolled. The study observes patients over 12 weeks initially, with additional data collected at 24 weeks and optionally at 36 weeks. There is no randomization or placebo group, as this is an observational study focusing on those already receiving brolucizumab. During the study, researchers will collect safety information, including adverse events up to 12 weeks and beyond. They will also evaluate vision-related outcomes such as changes in visual acuity and retinal thickness at baseline and follow-up visits. Other data include treatment history, injection numbers, and disease activity. Participants will be monitored through clinical assessments over the study period, which may last up to 36 weeks.

Regulatory Post-Marketing Surveillance Study for Brolucizumab