To determine safety, pharmacokinetics, and duration of effect of intravitreally administered AIV007 gel suspension in subjects with neovascular age-related macular degeneration
AIV007 is a multiple kinase inhibitor of vascular endothelial growth factor receptors (VEGFR 1, -2 \& -3); fibroblast growth factor receptors (FGFR-1, -2, -3 \& -4); and platelet-derived growth factor receptors (PDGFR-α \& β)1. Lenvatinib is the active pharmaceutical ingredient in AIV007 formulation that is FDA-approved for oral administration for patients with advanced renal cell carcinoma (RCC), differentiated thyroid cancer (DTC), unresectable hepatocellular carcinoma (HCC), and advanced endometrial carcinoma (Lenvima USPI 2021; NDA 206947). AIV007 is a novel, thermoresponsive gel suspension for intravitreal administration proposed to form a durable depot inside the eye. This monotherapy is being evaluated for the treatment of retinal and choroidal vascular disease. A single intravitreal treatment in 3 subjects was evaluated using 2 doses to evaluate depot formation, safety and biological activity by measuring visual acuity, reduction in retinal fluids associated with vision and effects of fibrosis.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
intravitreal
Salehi Retina Institute
Huntington Beach, California, United States
Retina Research Institute of Texas
Abilene, Texas, United States
Adverse Events
Incidence of adverse events
Time frame: approximately 224 days
Mean change from baseline in BCVA
Number of ETDRS letters
Time frame: approximately 224 days
Mean change from baseline in central subfield thickness as measured by optical coherence tomography
OCT read by a central reading center
Time frame: approximately 224 days
Mean time to rescue medication (administration of anti-VEGF medication)
Time frame: approximately 224 days
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