Trials / Recruiting
RecruitingNCT06591793
Study of Subretinally Injected AAVB-081 in Patients With Usher Syndrome Type IB (USH1B) Retinitis Pigmentosa
A Phase 1/2 Multicenter, Open-label, Dose Escalation, Safety and Efficacy Study of Subretinal Administration of Dual AAV8.MYO7A, AAVB-081 in Subjects With Usher Syndrome Type IB (USH1B) Retinitis Pigmentosa
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- Sponsor
- AAVantgarde Bio Srl · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the 081-101 study is to evaluate the safety and tolerability of a single subretinal injection of AAVB-081 in USH1B patients with retinitis pigmentosa due to a mutation in the MYO7A gene. The study will also assess the initial efficacy following AAVB-081 administration.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | AAVB-081 | Single subretinal administration |
Timeline
- Start date
- 2024-07-02
- Primary completion
- 2025-07-01
- Completion
- 2029-07-01
- First posted
- 2024-09-19
- Last updated
- 2025-05-02
Locations
3 sites across 2 countries: Italy, United Kingdom
Source: ClinicalTrials.gov record NCT06591793. Inclusion in this directory is not an endorsement.