Clinical trial · Interventional
Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma
A Phase 1/2 Trial of AAVAnc80-antiVEGF Gene Therapy in Individuals With Unilateral Vestibular Schwannoma
NCT06517888CI-TRIAL-00107396recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Vestibular Schwannoma | Vestibular Schwannoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AAVAnc80-antiVEGF via Akouos Delivery Device | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- 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.
- interventionNames
- Combination Product: AAVAnc80-antiVEGF via Akouos Delivery Device
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- 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.
- interventionNames
- Combination Product: AAVAnc80-antiVEGF via Akouos Delivery Device
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.