This is a single-arm, open-label study where all patients will receive a single injection of SOK583A1 (40 mg/mL) provided in a vial kit at Baseline. The total study duration for the individual participant is approximately 31 days.
Subjects with nAMD received a single dose of study treatment (2 mg SOK583 in 0.05 mL) in line with the Eylea USPI, which recommends a dose of 2 mg aflibercept (0.05 mL) administered by IVT injection. Only subjects already under IVT Eylea treatment and hence familiar with the IVT procedure were eligible for the study. Administration of the study treatment was embedded into their routine treatment scheme.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
SOK583A1 will be provided in a vial kit, with 40 mg/mL of aflibercept solution for IVT injection (2 mg/0.05 mL)
Sandoz Investigational Site
Poway, California, United States
Sandoz Investigational Site
Marietta, Georgia, United States
Sandoz Investigational Site
Oak Forest, Illinois, United States
Sandoz Investigational Site
Liverpool, New York, United States
Number of Participants With Ocular Treatment Emergent Adverse Events
Number of participants with ocular treatment emergent adverse events were reported.
Time frame: 31 days
Number of Participants With Non-ocular Treatment Emergent Adverse Events
Number of participants with non-ocular treatment emergent adverse events were reported.
Time frame: 31 days
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Sandoz Investigational Site
Lynchburg, Virginia, United States