AAVAnc80-antiVEGF via Akouos Delivery Device: AAVAnc80-antiVEGF is a sterile suspension intended to be administered via intracochlear administration as a single dose using the Akouos Delivery Device
Study 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 achieve the intended product performance.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Criteria for Inclusion:
1. Presence of unilateral, progressive vestibular schwannoma.
2. Vestibular schwannoma larger than 2 mm.
3. Profound hearing loss, defined by pure-tone audiometry thresholds or word recognition score, in the affected ear.
4. 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:
1. Prior diagnosis of NF2 and/or bilateral vestibular schwannoma.
2. Prior surgery or radiation therapy for vestibular schwannoma.
3. Clinical history consistent with endolymphatic hydrops (documented fluctuating sensorineural hearing loss and/or episodic vertigo) in the affected ear.
4. Profound hearing loss, defined by pure-tone audiometry thresholds or word recognition score, in the unaffected ear.
5. 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.
Primary outcome measure(s)
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)
Trial sites (4)
Facility
City
Region
Status
Johns Hopkins Hospital
Baltimore
Maryland
Recruiting
Mayo Clinic
Rochester
Minnesota
Recruiting
Vanderbilt Bill Wilkerson Center
Nashville
Tennessee
Recruiting
University of Texas Southwestern
Dallas
Texas
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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