Vestibular Schwannoma
Conditions
Keywords
Vestibular schwannoma, Hearing loss, Acoustic neuroma, anti-VEGF
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 achieve the intended product performance.
Interventions
COMBINATION_PRODUCTAAVAnc80-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
Sponsors
Akouos, Inc.
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Volume | through trial completion, approximately one year | Change from baseline in tumor size via MRI (volumetric analysis) |
| Performance of Akouos Delivery Device | through trial completion, approximately one year | Performance based on the frequency of device deficiencies observed during delivery of AAVAnc80-antiVEGF to the intracochlear space |
Countries
United States
Contacts
CONTACTAkouos Clinical Trials
STUDY_DIRECTORAaron Tward, MD
Eli Lilly and Company
Outcome results
None listed