The primary objective of the study is to determine if the pre-filled syringe (PFS) supports successful preparation and accurate administration of an aflibercept injection. The secondary objective of the study is to assess ocular safety in the study eye.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
65
IAI prepared and administered with a pre-filled syringe (PFS)
Regeneron Study Site
Houston, Texas, United States
Regeneron Study Site
The Woodlands, Texas, United States
Number of Aflibercept Injections Successfully Administered Utilizing the Prefilled Syringe (PFS)
Participants received a single dose of study drug, administered in the selected study eye with the PFS by a retina specialist. Physician assessed successful aflibercept preparation and administration with the PFS.
Time frame: At Day 1
Incidence of Ocular Treatment-Emergent Adverse Events (TEAEs) of Study Eye Through Day 29
A treatment emergent AE (TEAE) is an adverse event starting after study eye injection and no later than 28 days after administration of study medication.
Time frame: Baseline through Day 29
Incidence of Ocular Serious TEAEs of Study Eye Through Day 29
A serious treatment emergent AE (TEAE) is a serious adverse event starting after study eye injection and no later than 28 days after administration of study medication.
Time frame: Baseline through Day 29
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