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

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

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07503613

Enrollment

100

Registered

2026-03-31

Start date

2026-03-02

Completion date

2040-04-01

Last updated

2026-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vestibular Schwannoma

Keywords

anti-VEGF, Hearing loss, Acoustic neuroma, Vestibular schwannoma

Brief summary

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

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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Long term safety of AAVAnc80-antiVEGF, including late-occurring adverse events (AEs	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

Secondary

Measure	Time frame	Description
Tumor Volume	Through study completion, approximately four years.	Change from baseline in tumor size via MRI (volumetric analysis)
Pure-tone audiometry	Through study completion, approximately four years.	Change from baseline in pure-tone audiometry
Word recognition testing	Through study completion, approximately four years.	Change from baseline in word recognition testing
Otologic questionnaires	Through study completion, approximately four years.	Change from baseline in otologic questionnaire scores

Countries

United States

Contacts

STUDY_DIRECTORAaron Tward, MD

Eli Lilly and Company

Outcome results