[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555884":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":103,"collaborators":105,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":28,"eligibilityCriteria":113,"healthyVolunteers":109,"sex":114,"minAge":115,"maxAge":28,"enrollmentInfo":116,"targetDuration":28,"studyType":119,"phases":120,"briefSummary":123,"conditions":124,"keywords":126,"overallStatus":43,"whyStopped":28,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},{"fullName":5,"class":6},"Akouos, Inc.","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Combination Product: AAVAnc80-antiVEGF via Akouos Delivery Device",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2","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.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Cohort 3","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",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"COMBINATION_PRODUCT","AAVAnc80-antiVEGF via Akouos Delivery Device","AAVAnc80-antiVEGF is a sterile suspension intended to be administered via intracochlear administration as a single dose using the Akouos Delivery Device",[9,15,19],null,[30],{"name":31,"affiliation":32,"role":33},"Aaron Tward, MD","Eli Lilly and Company","STUDY_DIRECTOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":28,"email":39},"Akouos Clinical Trials","CONTACT","+1 (857) 410-1816","AkouosClinicalTrials@Lilly.com",[41,59,74,89],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Johns Hopkins Hospital","RECRUITING","Baltimore","Maryland","21205","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-76.61219,39.29038,{"lat":53,"lon":52},[56],{"name":28,"role":37,"phone":57,"phoneExt":28,"email":58},"+1 (410) 955 3157","ototrials@live.johnshopkins.edu",{"facility":60,"status":43,"city":61,"state":62,"zip":63,"country":47,"countryCode":48,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Mayo Clinic","Rochester","Minnesota","55905",{"type":50,"coordinates":65},[66,67],-92.4699,44.02163,{"lat":67,"lon":66},[70],{"name":71,"role":37,"phone":72,"phoneExt":28,"email":73},"Dan Osland","+1 507-266-1470","Osland.daniel@mayo.edu",{"facility":75,"status":43,"city":76,"state":77,"zip":78,"country":47,"countryCode":48,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Vanderbilt Bill Wilkerson Center","Nashville","Tennessee","37232",{"type":50,"coordinates":80},[81,82],-86.78444,36.16589,{"lat":82,"lon":81},[85],{"name":86,"role":37,"phone":87,"phoneExt":28,"email":88},"Taha Jan, MD","+1 (615) 322-4386","Taha.a.jan@vumc.org",{"facility":90,"status":43,"city":91,"state":92,"zip":93,"country":47,"countryCode":48,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"University of Texas Southwestern","Dallas","Texas","75390",{"type":50,"coordinates":95},[96,97],-96.80667,32.78306,{"lat":97,"lon":96},[100],{"name":28,"role":37,"phone":101,"phoneExt":28,"email":102},"+1 (214) 648-3626","OTOResearch@UTSouthwestern.edu",{"type":104,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[106],{"name":32,"class":6},"100555884","phase-1-anti-vegf-gene-therapy-trial-for-vestibular-schwannoma-100555884",false,"NCT06517888","Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma","A Phase 1\u002F2 Trial of AAVAnc80-antiVEGF Gene Therapy in Individuals With Unilateral Vestibular Schwannoma","Criteria for Inclusion:\n\n1. Presence of unilateral, progressive vestibular schwannoma.\n2. Vestibular schwannoma larger than 2 mm.\n3. Profound hearing loss, defined by pure-tone audiometry thresholds or word recognition score, in the affected ear.\n4. Able and willing to comply with all trial requirements, including willingness to participate in a separate long term follow-up study after completion of this trial.\n\nCriteria for Exclusion:\n\n1. Prior diagnosis of NF2 and\u002For bilateral vestibular schwannoma.\n2. Prior surgery or radiation therapy for vestibular schwannoma.\n3. Clinical history consistent with endolymphatic hydrops (documented fluctuating sensorineural hearing loss and\u002For episodic vertigo) in the affected ear.\n4. Profound hearing loss, defined by pure-tone audiometry thresholds or word recognition score, in the unaffected ear.\n5. Prior participation in a clinical trial with an investigational drug within six months prior to administration (Day 0), or any prior participation in a gene therapy clinical trial.","ALL","18 Years",{"count":117,"type":118},27,"ESTIMATED","INTERVENTIONAL",[121,122],"PHASE1","PHASE2","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.",[125],"Vestibular Schwannoma",[127,128,129,130],"Vestibular schwannoma","Hearing loss","Acoustic neuroma","anti-VEGF","2026-04-01",{"date":133,"type":134},"2026-04-06","ACTUAL",{"date":136,"type":134},"2025-01-17",{"date":138,"type":118},"2029-08",{"name":5,"class":6},4]