Study to Evaluate an 8 mg Aflibercept (EYLEA®) Prefilled Syringe (PFS)
Status:
Active, not recruiting
Trial end date:
2024-05-29
Target enrollment:
Participant gender:
Summary
Regeneron Pharmaceuticals developed a single-dose pre-filled syringe (PFS) to deliver 8 mg
aflibercept. The PFS is a convenient device that contains the study medication that will be
injected in your study eye. A PFS offers a sterile, single dose of study drug within the
syringe; this eliminates the need for the retina specialist to prepare the injection syringe
from a separate vial.
This Phase IIIb study is focused on patients with diabetic macular edema (DME) and
neovascular (wet) age-related macular degeneration (nAMD).
The main aim of the study is to evaluate if the 8 mg aflibercept PFS allows for successful
preparation and administration of 8 mg aflibercept by retina specialists. The study will also
assess the safety of 8 mg aflibercept PFS use. Regeneron will use the information from the
study to better understand if the PFS can be used safely and effectively by retina
specialists to administer 8 mg aflibercept.