Actively Recruiting
Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma
Led by Akouos, Inc. · Updated on 2026-04-06
27
Participants Needed
4
Research Sites
236 weeks
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 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.
CONDITIONS
Official 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, based on hearing tests
- Able and willing to follow all trial requirements, including joining a long-term follow-up study after this trial
You will not qualify if you...
- Prior diagnosis of neurofibromatosis type 2 or bilateral vestibular schwannoma
- Previous surgery or radiation therapy for vestibular schwannoma
- History suggesting endolymphatic hydrops in the affected ear, such as fluctuating hearing loss or episodic vertigo
- Profound hearing loss in the unaffected ear
- Participation in a clinical trial with an investigational drug within six months before treatment, or any prior gene therapy trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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