Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1
Adult participants to receive a single unilateral intracochlear administration of AAVAnc80-antiVEGF (dose level 1) in the study ear using a sterile, one-time use investigational medical device.
  • Combination Product: 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
Experimental
Cohort 2
Adult participants to receive a single unilateral intracochlear administration of AAVAnc80-antiVEGF (dose level 2) in the study ear using a sterile, one-time use investigational medical device.
  • Combination Product: 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
Experimental
Cohort 3
Adult participants to receive a single unilateral intracochlear administration of AAVAnc80-antiVEGF (dose level 3) in the study ear using a sterile, one-time use investigational medical device
  • Combination Product: 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

Recruiting Locations

Vanderbilt Bill Wilkerson Center
Nashville, Tennessee 37232
Contact:
Taha Jan, MD
+1 (615) 322-4386
Taha.a.jan@vumc.org

More Details

Status
Recruiting
Sponsor
Akouos, Inc.

Study Contact

Akouos Clinical Trials
+1 (857) 410-1816
AkouosClinicalTrials@Lilly.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.