Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma
A legfontosabb adatok
- Hol
- Baltimore, Dallas, Nashville és Rochester (Egyesült Államok)Mind a 4 helyszín megnézése
- Fázis
- 1/2. fázis
Helyszínek itt: Egyesült Államok
- Johns Hopkins HospitalBaltimore, Egyesült ÁllamokContact: Lilly Clinical TrialsRésztvevőt keres
- University of Texas, SouthwesternDallas, Egyesült ÁllamokContact: Lilly Clinical TrialsRésztvevőt keres
- Vanderbilt Bill Wilkerson CenterNashville, Egyesült ÁllamokContact: Taha Jan, MDRésztvevőt keres
- Mayo ClinicRochester, Egyesült ÁllamokContact: Dan OslandRésztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Eli Lilly and Company
- Azonosító
- NCT06517888
- A regiszteradat frissítve
- 2026. november 4.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
A Phase 1/2 Trial of AAVAnc80-antiVEGF Gene Therapy in Individuals With Unilateral Vestibular Schwannoma
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.
Criteria for Inclusion:; Presence of unilateral, progressive vestibular schwannoma; Vestibular schwannoma larger than 2 mm; Profound hearing loss, defined by pure-tone audiometry thresholds or word recognition score, in the affected ear; 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; Criteria for Exclusion:; Prior diagnosis of NF2 and/or bilateral vestibular schwannoma; Prior surgery or radiation therapy for vestibular schwannoma; Clinical history consistent with endolymphatic hydrops (documented fluctuating sensorineural hearing loss and/or episodic vertigo) in the affected ear; Profound hearing loss, defined by pure-tone audiometry thresholds or word recognition score, in the unaffected ear; 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.