Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06517888 | Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma | PHASE1 | RECRUITING | 27 | — | — | Jan 17, 2025 | Aug 1, 2029 | Apr 6, 2026 | 4 | United States |
AEs with relationship to the investigational medicinal product and/or to the administration procedure (including the delivery device)
| Arm | Type | Description |
|---|---|---|
| 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. |
| Cohort 2 | EXPERIMENTAL | 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. |
| Cohort 3 | EXPERIMENTAL | 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 |
| Name | Type | Description |
|---|---|---|
| AAVAnc80-antiVEGF via Akouos Delivery Device | COMBINATION_PRODUCT | AAVAnc80-antiVEGF is a sterile suspension intended to be administered via intracochlear administration as a single dose using the Akouos Delivery Device |
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 requirem...