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
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
100
University of Texas Southwestern
Dallas, Texas, United States
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.
Tumor Volume
Change from baseline in tumor size via MRI (volumetric analysis)
Time frame: Through study completion, approximately four years.
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