Long Term Follow-up Study of AAVAnc80-antiVEGF Gene Therapy

April 1, 2026 updated by: Akouos, Inc.

An Evaluation of the Long Term Safety and Efficacy of AAVAnc80-antiVEGF Gene Therapy in Individuals With Vestibular Schwannoma

This multi-center, observational, post-intervention LTFU study will monitor for safety and efficacy of AAVAnc80- antiVEGF in individuals with vestibular schwannoma who have previously received an intracochlear administration of AAVAnc80-antiVEGF in an interventional clinical trial

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

After completing one year of initial safety and efficacy assessments following an intracochlear administration of AAVAnc80-antiVEGF, participants will continue to be observed for an additional approximately four years of safety and efficacy follow-up in this LTFU study, for a total of approximately five years observations after product administration. For each participant, evaluations in the LTFU study will occur at annual visits through Year 5; with the aim to characterize long-term safety, including potential delayed adverse events, as well as characterizing the durability of effect of AAVAnc80-antiVEGF

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Individuals with vestibular schwannoma who received an intracochlear administration of AAVAnc80-antiVEGF in an interventional clinical trial.

Description

Inclusion Criteria:

-Individual with vestibular schwannoma who received an intracochlear administration of

AAVAnc80-antiVEGF in an interventional clinical trial.

-Participant willingness to comply with all study requirements as evidenced by successful completion of the informed consent process.

Exclusion Criteria:

-Any condition that would not allow the potential participant to complete follow-up examinations during the course of the study and/or, in the opinion of the Investigator, makes the potential participant unsuitable for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Study Participants
Individuals with vestibular schwannoma who received an intracochlear administration of AAVAnc80-antiVEGF in an interventional clinical trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long term safety of AAVAnc80-antiVEGF, including late-occurring adverse events (AEs
Time Frame: Through study completion, approximately four years.
  1. the development of new or exacerbation of malignancies (oncologic), neurologic, rheumatologic or other autoimmune, hematologic disorders, or new infections (if the infection is potentially related to AAVAnc80-antiVEGF)
  2. AEs that are related to the IMP and/or the administration procedure
  3. AEs of special interest
  4. all serious adverse events, regardless of severity
Through study completion, approximately four years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor Volume
Time Frame: Through study completion, approximately four years.
Change from baseline in tumor size via MRI (volumetric analysis)
Through study completion, approximately four years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akouos, Inc.

Collaborators

Eli Lilly and Company

Investigators

  • Study Director: Aaron Tward, MD, Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2026

Primary Completion (Estimated)

April 1, 2040

Study Completion (Estimated)

April 1, 2040

Study Registration Dates

First Submitted

March 26, 2026

First Submitted That Met QC Criteria

March 26, 2026

First Posted (Actual)

March 31, 2026

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AK-antiVegf-LTFU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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