Long Term Follow-up Study of AAVAnc80-antiVEGF Gene Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Vestibular Schwannoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Evaluation of the Long Term Safety and Efficacy of AAVAnc80-antiVEGF Gene Therapy in Individuals With Vestibular Schwannoma
Overview
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
Primary outcome measures
- Long term safety of AAVAnc80-antiVEGF, including late-occurring adverse events (AEs [Time frame: Through study completion, approximately four years.]
Secondary outcome measures (4)
- Tumor Volume [Time frame: Through study completion, approximately four years.]
- Pure-tone audiometry [Time frame: Through study completion, approximately four years.]
- Word recognition testing [Time frame: Through study completion, approximately four years.]
- Otologic questionnaires [Time frame: Through study completion, approximately four years.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
United States · 1 center
- University of Texas Southwestern — Dallas
Identifiers
NCT: NCT07503613 · AK-antiVegf-LTFU