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Trial Title:
Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma
NCT ID:
NCT06517888
Condition:
Vestibular Schwannoma
Conditions: Official terms:
Neurilemmoma
Neuroma, Acoustic
Conditions: Keywords:
Vestibular schwannoma
Hearing loss
Acoustic neuroma
anti-VEGF
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Combination Product
Intervention name:
AAVAnc80-antiVEGF via Akouos Delivery Device
Description:
AAVAnc80-antiVEGF is a sterile suspension intended to be administered via intracochlear
administration as a single dose using the Akouos Delivery Device
Arm group label:
Cohort 1
Arm group label:
Cohort 2
Arm group label:
Cohort 3
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Amy Tuchscherer
Phone:
507-538-5862
Email:
Tuchscherer.Amy@mayo.edu
Facility:
Name:
University of Texas Southwestern
Address:
City:
Dallas
Zip:
75390
Country:
United States
Status:
Recruiting
Contact:
Phone:
214-648-3626
Email:
OTOResearch@UTSouthwestern.edu
Start date:
September 2024
Completion date:
August 2029
Lead sponsor:
Agency:
Akouos, Inc.
Agency class:
Industry
Collaborator:
Agency:
Eli Lilly and Company
Agency class:
Industry
Source:
Akouos, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06517888
