Status:
RECRUITING
Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma
Lead Sponsor:
Akouos, Inc.
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Vestibular Schwannoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 achie...
Eligibility Criteria
Inclusion
- Criteria for Inclusion:
- Presence of unilateral, progressive vestibular schwannoma.
- Vestibular schwannoma larger than 2 mm.
- Profound hearing loss, defined by pure-tone audiometry thresholds or word recognition score, in the affected ear.
- Able and willing to comply with all trial requirements, including willingness to participate in a separate long term follow-up study after completion of this trial.
- Criteria for Exclusion:
- Prior diagnosis of NF2 and/or bilateral vestibular schwannoma.
- Prior surgery or radiation therapy for vestibular schwannoma.
- Clinical history consistent with endolymphatic hydrops (documented fluctuating sensorineural hearing loss and/or episodic vertigo) in the affected ear.
- Profound hearing loss, defined by pure-tone audiometry thresholds or word recognition score, in the unaffected ear.
- Prior participation in a clinical trial with an investigational drug within six months prior to administration (Day 0), or any prior participation in a gene therapy clinical trial.
Exclusion
Key Trial Info
Start Date :
January 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2029
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT06517888
Start Date
January 17 2025
End Date
August 1 2029
Last Update
October 14 2025
Active Locations (4)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
3
Vanderbilt Bill Wilkerson Center
Nashville, Tennessee, United States, 37232
4
University of Texas Southwestern
Dallas, Texas, United States, 75390