A Phase 1/2 interventional study of AAVAnc80-antiVEGF via Akouos Delivery Device in Vestibular Schwannoma, sponsored by Akouos, Inc.. Recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-06.
Sponsored by Akouos, Inc. · Phase 1/2, Interventional, and Treatment
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.
98 studies on the registry are indexed under Neuroma, Acoustic; 27 are open to participants now.
This study's planned enrollment of 27 is close to the median of 27 across 66 interventional studies indexed under Neuroma, Acoustic.
Browse Neuroma, Acoustic studies →Akouos, Inc. is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Criteria for Inclusion:
Criteria for Exclusion:
Adult participants to receive a single unilateral intracochlear administration of AAVAnc80-antiVEGF (dose level 1) in the study ear using a sterile, one-time use investigational medical device.
Combination Product: AAVAnc80-antiVEGF via Akouos Delivery Device
Adult participants to receive a single unilateral intracochlear administration of AAVAnc80-antiVEGF (dose level 2) in the study ear using a sterile, one-time use investigational medical device.
Combination Product: AAVAnc80-antiVEGF via Akouos Delivery Device
Adult participants to receive a single unilateral intracochlear administration of AAVAnc80-antiVEGF (dose level 3) in the study ear using a sterile, one-time use investigational medical device
Combination Product: AAVAnc80-antiVEGF via Akouos Delivery Device
AAVAnc80-antiVEGF is a sterile suspension intended to be administered via intracochlear administration as a single dose using the Akouos Delivery Device
Frequency 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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Akouos, Inc.