NCT06517888

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
39mo left

Started Jan 2025

Longer than P75 for phase_1

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress29%
Jan 2025Aug 2029

First Submitted

Initial submission to the registry

July 19, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 24, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

January 17, 2025

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2029

Last Updated

March 31, 2026

Status Verified

October 1, 2025

Enrollment Period

4.5 years

First QC Date

July 19, 2024

Last Update Submit

March 26, 2026

Conditions

Vestibular Schwannoma

Keywords

Vestibular schwannomaHearing lossAcoustic neuromaanti-VEGF

Outcome Measures

Primary Outcomes (1)

  • Frequency of Adverse Events (AEs)

    AEs with relationship to the investigational medicinal product and/or to the administration procedure (including the delivery device)

    through trial completion, approximately one year

Secondary Outcomes (2)

  • Tumor Volume

    through trial completion, approximately one year

  • Performance of Akouos Delivery Device

    through trial completion, approximately one year

Study Arms (3)

Cohort 1

EXPERIMENTAL

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

Cohort 2

EXPERIMENTAL

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

Cohort 3

EXPERIMENTAL

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

Interventions

AAVAnc80-antiVEGF via Akouos Delivery DeviceCOMBINATION_PRODUCT

AAVAnc80-antiVEGF is a sterile suspension intended to be administered via intracochlear administration as a single dose using the Akouos Delivery Device

Cohort 1Cohort 2Cohort 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Vanderbilt Bill Wilkerson Center

Nashville, Tennessee, 37232, United States

RECRUITING

University of Texas Southwestern

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Neuroma, AcousticHearing Loss

Condition Hierarchy (Ancestors)

NeurilemmomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeuromaNerve Sheath NeoplasmsNeoplasms, Nerve TissueCranial Nerve NeoplasmsNervous System NeoplasmsNeoplasms by SitePeripheral Nervous System NeoplasmsVestibulocochlear Nerve DiseasesRetrocochlear DiseasesEar DiseasesOtorhinolaryngologic DiseasesOtorhinolaryngologic NeoplasmsCranial Nerve DiseasesNervous System DiseasesHearing DisordersSensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Aaron Tward, MD

    Eli Lilly and Company

    STUDY DIRECTOR

Central Study Contacts

Aaron Akouos Clinical Trials, MD

CONTACT

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

Aaron Tward

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2024

First Posted

July 24, 2024

Study Start

January 17, 2025

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

August 1, 2029

Last Updated

March 31, 2026

Record last verified: 2025-10

Locations

US(4)