The primary objective of the study is to investigate the safety and tolerability of intravitreal (IVT) REGN910-3 and IVT REGN910 in patients with neovascular age-related macular degeneration (AMD), and separately in patients with diabetic macular edema (DME).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
20
Unnamed facility
Beverly Hills, California, United States
Unnamed facility
Winter Haven, Florida, United States
Unnamed facility
Boston, Massachusetts, United States
Unnamed facility
West Columbia, South Carolina, United States
Unnamed facility
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of TEAEs through week 24 in patients treated with IVT REGN910-3 and IVT REGN910 TEAEs through week 24 in patients treated with IVT REGN910-3 and IVT REGN910
Time frame: Change from baseline to week 24
Pharmacokinetic (PK) profile
PK profile may include, but is not limited to, the following: * AUCall - area under the curve (AUC) computed from time zero to the time of the last concentration * AUCall/Dose - AUCall-to-dose ratio * AUClast - AUC computed from time zero to the time of the last positive concentration * AUClast/Dose - AUClast-to-dose ratio * Cmax - the peak concentration * Cmax/Dose - Cmax-to-dose ratio
Time frame: Baseline to week 24
Development of Anti-drug antibodies (ADA) after IVT injection of REGN910-3
Time frame: Baseline to week 24
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Abilene, Texas, United States