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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma
At a glance
Conditions
Where it's being run
4 sites across 4 statesStudy leadership
- Aaron Tward, MD · STUDY_DIRECTOR · Eli Lilly and Company
Who to contact
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What this trial measures
- 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)