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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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This trial will evaluate the safety and tolerability of a single unilateral administration of one of three dose levels of AAVAnc80-antiVEGF and will evaluate the Akouos delivery device to safely achieve the intended product performance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Adult participants to receive a single unilateral intracochlear administration of AAVAnc80-antiVEGF (dose level 1) in the study ear using a sterile, one-time use investigational medical device. |
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| Cohort 2 | Experimental | Adult participants to receive a single unilateral intracochlear administration of AAVAnc80-antiVEGF (dose level 2) in the study ear using a sterile, one-time use investigational medical device. |
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| Cohort 3 | Experimental | Adult participants to receive a single unilateral intracochlear administration of AAVAnc80-antiVEGF (dose level 3) in the study ear using a sterile, one-time use investigational medical device |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AAVAnc80-antiVEGF via Akouos Delivery Device | Combination Product | AAVAnc80-antiVEGF is a sterile suspension intended to be administered via intracochlear administration as a single dose using the Akouos Delivery Device |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Adverse Events (AEs) | AEs with relationship to the investigational medicinal product and/or to the administration procedure (including the delivery device) | through trial completion, approximately one year |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Volume | Change from baseline in tumor size via MRI (volumetric analysis) | through trial completion, approximately one year |
| Performance of Akouos Delivery Device | Performance based on the frequency of device deficiencies observed during delivery of AAVAnc80-antiVEGF to the intracochlear space |
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Criteria for Inclusion:
Criteria for Exclusion:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Akouos Clinical Trials | Contact | +1 (857) 410-1816 | AkouosClinicalTrials@Lilly.com |
| Name | Affiliation | Role |
|---|---|---|
| Aaron Tward, MD | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Recruiting | Baltimore | Maryland | 21205 | 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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| through trial completion, approximately one year |
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Vanderbilt Bill Wilkerson Center | Recruiting | Nashville | Tennessee | 37232 | United States |
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| University of Texas Southwestern | Recruiting | Dallas | Texas | 75390 | United States |
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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 |