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Enrolling by Invitation

NCT Number: NCT07503613

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

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

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Key information

Conditions

Vestibular Schwannoma Cranial Nerve Diseases Cranial Nerve Neoplasms Ear Diseases Hearing Disorders Hearing Loss Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Nerve Sheath Neoplasms Nervous System Diseases Nervous System Neoplasms Neurilemmoma Neuroectodermal Tumors Neuroendocrine Tumors Neurologic Manifestations Neuroma Neuroma, Acoustic Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pathological Conditions, Signs and Symptoms Peripheral Nervous System Neoplasms Retrocochlear Diseases Sensation Disorders Signs and Symptoms Vestibulocochlear Nerve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Texas Southwestern

Dallas, Texas, 75390, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Long term safety of AAVAnc80-antiVEGF, including late-occurring adverse events (AEs

    Time frame: Through study completion, approximately four years.

    • 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)
    • AEs that are related to the IMP and/or the administration procedure
    • AEs of special interest
    • all serious adverse events, regardless of severity

Secondary outcomes

  1. Tumor Volume

    Time frame: Through study completion, approximately four years.

    Change from baseline in tumor size via MRI (volumetric analysis)

  2. Pure-tone audiometry

    Time frame: Through study completion, approximately four years.

    Change from baseline in pure-tone audiometry

  3. Word recognition testing

    Time frame: Through study completion, approximately four years.

    Change from baseline in word recognition testing

  4. Otologic questionnaires

    Time frame: Through study completion, approximately four years.

    Change from baseline in otologic questionnaire scores

Sponsors and collaborators

Lead sponsor

Akouos, Inc.

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2040
Study completion
2040
First posted
Mar 31, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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