This was a multicenter, open label study that is designed to evaluate the safety of brolucizumab 6 mg in a prefilled syringe in subjects with neovascular age related macular degeneration and to support collection of observations of the prefilled syringe use for intravitreal injection.
The primary objective of this study was to evaluate the safety of brolucizumab 6 mg delivered in a pre-filled syringe (PFS) in subjects with neovascular age-related macular degeneration (nAMD) with the primary endpoint being the incidence of ocular and non-ocular adverse events (AEs). There were no other objectives for this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
6 mg in prefilled syringe
Novartis Investigative Site
Altamonte Springs, Florida, United States
Novartis Investigative Site
Pensacola, Florida, United States
Novartis Investigative Site
Richmond, Virginia, United States
The Safety of Brolucizumab 6 mg Delivered in Prefilled Syringe in Patients With Neovascular Age Related Macular Degeneration
The safety is defined as the incidence of ocular and non-ocular adverse events
Time frame: Up to Day 31
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