Actively Recruiting
A Phase 1/2 Trial of AAVAnc80-antiVEGF Gene Therapy in Individuals With Unilateral Vestibular Schwannoma
Led by Akouos, Inc. · Updated on 2026-04-06
27
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Akouos, Inc.
Lead Sponsor
E
Eli Lilly and Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and tolerability of a single unilateral administration of one of three dose levels of AAVAnc80-antiVEGF gene therapy in adults with unilateral vestibular schwannoma, a type of tumor affecting the ear. The trial also assesses the performance of the Akouos delivery device designed to safely deliver the gene therapy to the inner ear. This is a Phase 1/2 interventional trial sponsored by Akouos, Inc.
CONDITIONS
Brief Title
Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Presence of unilateral, progressive vestibular schwannoma
- Vestibular schwannoma larger than 2 mm
- Profound hearing loss in the affected ear confirmed by pure-tone audiometry or word recognition score
- Able and willing to comply with all trial requirements, including participation in a long-term follow-up study after trial completion
You will not qualify if you...
- Prior diagnosis of NF2 and/or bilateral vestibular schwannoma
- Prior surgery or radiation therapy for vestibular schwannoma
- History of endolymphatic hydrops with fluctuating sensorineural hearing loss or episodic vertigo in the affected ear
- Profound hearing loss in the unaffected ear
- Prior participation in a clinical trial with an investigational drug within six months before administration or any prior gene therapy trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single administration with follow-up through approximately one year
Participants receive a single unilateral intracochlear administration of AAVAnc80-antiVEGF via the Akouos Delivery Device.
Multiple follow-up visits over approximately one year
Trial Site Locations
Total: 4 locations
1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
Actively Recruiting
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
3
Vanderbilt Bill Wilkerson Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
4
University of Texas Southwestern
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
A
Akouos Clinical Trials
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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