The primary objectives of the study are to determine the safety of high-dose aflibercept (hereafter referred to as HD) and to determine if HD provides greater intraocular pharmacodynamic (PD) effect and/or longer duration of action compared to intravitreal aflibercept injection (hereafter referred to as IAI).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
106
Intravitreally (IVT) administered as a liquid formulation in a vial
Intravitreally (IVT) administered as a liquid formulation in a vial
Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
Time frame: Up to Week 44
Number of Participants With at Least One Serious TEAE
Time frame: Up to Week 44
Number of Participants Without Retinal Fluid in the Center Subfield of Study Eye
Center subfield=the circular area in 1 millimeter (mm) diameter centered around the center point of the fovea. Without fluid defined as absence of intraretinal fluid (IRF) and/or subretinal fluid (SRF) in the center subfield. Presence of retinal fluid was assessed by spectral domain optical coherence tomography (SD-OCT)
Time frame: At Week 16
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Regeneron Study Site
Phoenix, Arizona, United States
Regeneron Study Site
Sun City, Arizona, United States
Regeneron Study Site
Encino, California, United States
Regeneron Study Site
Fullerton, California, United States
Regeneron Study Site
Mountain View, California, United States
Regeneron Study Site
Palm Desert, California, United States
Regeneron Study Site
Sacramento, California, United States
Regeneron Study Site
Santa Ana, California, United States
Regeneron Study Site
Colorado Springs, Colorado, United States
Regeneron Study Site
Golden, Colorado, United States
...and 36 more locations