To determine safety, pharmacokinetics, and duration of effect of periocularly administered AIV007 gel suspension in subjects with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME).
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). AiViva BioPharma, Inc. (AiViva) has developed a novel, thermoresponsive gel suspension of AIV007 for periocular administration to form a durable depot. This monotherapy is in development for the treatment of retinal and choroidal vascular disease (i.e., neovascular age-related macular degeneration (nAMD) \& diabetic macular edema (DME)). For preclinical and clinical (AIV007-E02) studies using periocular administration, AIV007 is injected outside the eyeball and the depot forms a soft mass, referred to as posterior juxtascleral depot (PJD) placement.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Periocular injection
Retina-Vitreous Associates
Beverly Hills, California, United States
Orange County Retina
Santa Ana, California, United States
Verum Research
Eugene, Oregon, United States
Valley Retina Institute
McAllen, Texas, United States
Adverse Events
Incidence of adverse events and serious adverse events
Time frame: Approximately 168 days
Mean change from baseline in best-corrected visual acuity (BCVA)
Number of Early Treatment Diabetic Retinopathy Study (ETDRS) letters
Time frame: Approximately 168 days
Mean change from baseline in central subfield thickness as measured by spectral domain optical coherence tomography (SD-OCT)
SD-OCT read by a central reading center
Time frame: Approximately 168 days
Mean time to rescue medication
number of days to receive rescue medication
Time frame: Approximately 168 days
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Texas Retina Associates
Plano, Texas, United States
Medical Center Ophthalmology
San Antonio, Texas, United States