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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Participants | Individuals with vestibular schwannoma who received an intracochlear administration of AAVAnc80-antiVEGF in an interventional clinical trial. |
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| Measure | Description | Time Frame |
|---|---|---|
| Long term safety of AAVAnc80-antiVEGF, including late-occurring adverse events (AEs |
| Through study completion, approximately four years. |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Volume | Change from baseline in tumor size via MRI (volumetric analysis) | Through study completion, approximately four years. |
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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.
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Individuals with vestibular schwannoma who received an intracochlear administration of AAVAnc80-antiVEGF in an interventional clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Aaron Tward, MD | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern | Dallas | Texas | 75390 | United States |
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| ID | Term |
|---|---|
| D009464 | Neuroma, Acoustic |
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D009442 | Neurilemmoma |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009463 | Neuroma |
| D018317 | Nerve Sheath Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D003390 | Cranial Nerve Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D010524 | Peripheral Nervous System Neoplasms |
| D000160 | Vestibulocochlear Nerve Diseases |
| D012181 | Retrocochlear Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D010039 | Otorhinolaryngologic Neoplasms |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D006311 | Hearing Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |