ClinicalTrials.gg
Enrolling by invitationNCT07503613Updated Nov 4, 2026

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

An observational study in Vestibular Schwannoma, sponsored by Eli Lilly and Company. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Eli Lilly and Company · Observational

Updated Nov 4, 2026Sponsor changedGo to Updates ↓
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
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Study 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

Read the 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

02

Conditions studied

  • Vestibular Schwannoma

Keywords

  • anti-VEGF
  • Hearing loss
  • Acoustic neuroma
  • Vestibular schwannoma
03

In context

Neuroma, Acoustic

100 studies on the registry are indexed under Neuroma, Acoustic; 28 are open to participants now.

This study's planned enrollment of 100 is above the median of 61 across 26 observational studies indexed under Neuroma, Acoustic.

Browse Neuroma, Acoustic studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.

Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 process.

Exclusion criteria

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.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Study Participants

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

06

What researchers measure

Primary outcomes

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

    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

    Time frame: Through study completion, approximately four years.

Secondary outcomes

  1. Tumor Volume

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

    Time frame: Through study completion, approximately four years.

  2. Pure-tone audiometry

    Change from baseline in pure-tone audiometry

    Time frame: Through study completion, approximately four years.

  3. Word recognition testing

    Change from baseline in word recognition testing

    Time frame: Through study completion, approximately four years.

  4. Otologic questionnaires

    Change from baseline in otologic questionnaire scores

    Time frame: Through study completion, approximately four years.

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Study locations

1 site
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Sponsor
Akouos, Inc.→Eli Lilly and Company
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    Sponsor Akouos, Inc.→Eli Lilly and Company
    + 1 other change: identifiers

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07503613
Responsible party
Sponsor
First posted
Mar 31, 2026
Start date
Mar 2, 2026
Primary completion
Apr 2040 (estimated)
Completion
Apr 2040 (estimated)
Last update
Nov 4, 2026

Study contacts

Aaron Tward, MD
study director · Eli Lilly and Company

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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