Gene Therapy Trial for Vestibular Schwannoma

This study is testing a new gene therapy called AAVAnc80-antiVEGF, delivered using the Akouos Delivery Device, for people with vestibular schwannoma. Vestibular schwannoma is a non-cancerous tumor that grows on the nerve connecting the ear to the brain. The therapy aims to target VEGF, a protein involved in blood vessel growth, which may contribute to tumor growth. We are looking for people aged 18 and older who have a progressive vestibular schwannoma larger than 2 mm in one ear and profound hearing loss in that same ear. The main goal is to see how safe the AAVAnc80-antiVEGF therapy is and if the delivery device works as intended. The study is currently recruiting 27 participants.

Study design
This is an interventional study with a planned enrollment of 27 participants. It will evaluate three different dose levels of the AAVAnc80-antiVEGF therapy.
What's involved
You would receive a single dose of AAVAnc80-antiVEGF delivered to one ear using the Akouos Delivery Device. You would also need to comply with all trial requirements, including participating in a separate long-term follow-up study.
Compensation
Not stated in the trial record.
Follow-up
The study will measure adverse events through trial completion, which is approximately one year. You will also participate in a separate long-term follow-up study after the trial ends.

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NCT06517888

Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma

Recruiting
PHASE1Ages 18+InterventionalTreatment
Akouos, Inc.
~27 participants
Updated 2026-04-06 on ClinicalTrials.gov
What's tested:AAVAnc80-antiVEGF via Akouos Delivery Device

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Frequency of Adverse Events (AEs)
Measured over through trial completion, approximately one year
Vestibular Schwannoma
4 sites across 4 states
Maryland1
Minnesota1
Tennessee1
Texas1
  • Aaron Tward, MD · STUDY_DIRECTOR · Eli Lilly and Company

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  • Frequency of Adverse Events (AEs)through trial completion, approximately one year

    AEs with relationship to the investigational medicinal product and/or to the administration procedure (including the delivery device)