This trial will evaluate the safety and tolerability of a single unilateral administration of one of three dose levels of AAVAnc80-antiVEGF and will evaluate the Akouos delivery device to safely achieve the intended product performance.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
AAVAnc80-antiVEGF is a sterile suspension intended to be administered via intracochlear administration as a single dose using the Akouos Delivery Device
Johns Hopkins Hospital
Baltimore, Maryland, United States
RECRUITINGMayo Clinic
Rochester, Minnesota, United States
RECRUITINGVanderbilt Bill Wilkerson Center
Nashville, Tennessee, United States
RECRUITINGFrequency of Adverse Events (AEs)
AEs with relationship to the investigational medicinal product and/or to the administration procedure (including the delivery device)
Time frame: through trial completion, approximately one year
Tumor Volume
Change from baseline in tumor size via MRI (volumetric analysis)
Time frame: through trial completion, approximately one year
Performance of Akouos Delivery Device
Performance based on the frequency of device deficiencies observed during delivery of AAVAnc80-antiVEGF to the intracochlear space
Time frame: through trial completion, approximately one year
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University of Texas Southwestern
Dallas, Texas, United States
RECRUITING