[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07503613":3,"trial-entities:NCT07503613":81,"trial-summary:NCT07503613":84},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":28,"interventions":31,"primary_outcomes":32,"secondary_outcomes":37,"sex":50,"minimum_age":51,"maximum_age":26,"healthy_volunteers":52,"eligibility_criteria":53,"std_ages":60,"locations":63,"central_contacts":73,"overall_officials":74,"references":79,"see_also_links":80},"NCT07503613","AK-antiVegf-LTFU","Long Term Follow-up Study of AAVAnc80-antiVEGF Gene Therapy","An Evaluation of the Long Term Safety and Efficacy of AAVAnc80-antiVEGF Gene Therapy in Individuals With Vestibular Schwannoma","ENROLLING_BY_INVITATION","2040-04","2026-03","2026-07-16","2026-03-02","Akouos, Inc.","INDUSTRY",true,"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",[19],"Vestibular Schwannoma",[21,22,23,24],"anti-VEGF","Hearing loss","Acoustic neuroma","Vestibular schwannoma","OBSERVATIONAL",null,[],{"count":29,"type":30},100,"ESTIMATED",[],[33],{"measure":34,"description":35,"timeFrame":36},"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)\n2. AEs that are related to the IMP and\u002For the administration procedure\n3. AEs of special interest\n4. all serious adverse events, regardless of severity","Through study completion, approximately four years.",[38,41,44,47],{"measure":39,"description":40,"timeFrame":36},"Tumor Volume","Change from baseline in tumor size via MRI (volumetric analysis)",{"measure":42,"description":43,"timeFrame":36},"Pure-tone audiometry","Change from baseline in pure-tone audiometry",{"measure":45,"description":46,"timeFrame":36},"Word recognition testing","Change from baseline in word recognition testing",{"measure":48,"description":49,"timeFrame":36},"Otologic questionnaires","Change from baseline in otologic questionnaire scores","ALL","18 Years",false,{"inclusion":54,"exclusion":57,"raw_text":59},[55,56],"Individual with vestibular schwannoma who received an intracochlear administration of","Participant willingness to comply with all study requirements as evidenced by successful completion of the informed consent process.",[58],"Any condition that would not allow the potential participant to complete follow-up examinations during the course of the study and\u002For, in the opinion of the Investigator, makes the potential participant unsuitable for the study.","Inclusion Criteria:\n\n-Individual with vestibular schwannoma who received an intracochlear administration of\n\nAAVAnc80-antiVEGF in an interventional clinical trial.\n\n-Participant willingness to comply with all study requirements as evidenced by successful completion of the informed consent process.\n\nExclusion Criteria:\n\n-Any condition that would not allow the potential participant to complete follow-up examinations during the course of the study and\u002For, in the opinion of the Investigator, makes the potential participant unsuitable for the study.",[61,62],"ADULT","OLDER_ADULT",[64],{"facility":65,"city":66,"state":67,"zip":68,"country":69,"geoPoint":70},"University of Texas Southwestern","Dallas","Texas","75390","United States",{"lat":71,"lon":72},32.78306,-96.80667,[],[75],{"name":76,"affiliation":77,"role":78},"Aaron Tward, MD","Eli Lilly and Company","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":82,"biomarkers":83},[19],[],{"nct_id":4,"found":52,"summary":26,"prompt_version":26}]