NCT06517888 Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma
| NCT ID | NCT06517888 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Akouos, Inc. |
| Condition | Vestibular Schwannoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 27 participants |
| Start Date | 2025-01-17 |
| Primary Completion | 2029-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 27 participants in total. It began in 2025-01-17 with a primary completion date of 2029-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Criteria for Inclusion: 1. Presence of unilateral, progressive vestibular schwannoma. 2. Vestibular schwannoma larger than 2 mm. 3. Profound hearing loss, defined by pure-tone audiometry thresholds or word recognition score, in the affected ear. 4. 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: 1. Prior diagnosis of NF2 and/or bilateral vestibular schwannoma. 2. Prior surgery or radiation therapy for vestibular schwannoma. 3. Clinical history consistent with endolymphatic hydrops (documented fluctuating sensorineural hearing loss and/or episodic vertigo) in the affected ear. 4. Profound hearing loss, defined by pure-tone audiometry thresholds or word recognition score, in the unaffected ear. 5. 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.
Contact & Investigator
Aaron Tward, MD
STUDY DIRECTOR
Eli Lilly and Company
Frequently Asked Questions
Who can join the NCT06517888 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Vestibular Schwannoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06517888 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06517888 currently recruiting?
Yes, NCT06517888 is actively recruiting participants. Contact the research team at AkouosClinicalTrials@Lilly.com for enrollment information.
Where is the NCT06517888 trial being conducted?
This trial is being conducted at Baltimore, United States, Rochester, United States, Nashville, United States, Dallas, United States.
Who is sponsoring the NCT06517888 clinical trial?
NCT06517888 is sponsored by Akouos, Inc.. The principal investigator is Aaron Tward, MD at Eli Lilly and Company. The trial plans to enroll 27 participants.