NCT06591793RecruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 2 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 16 Aug 2024
- Start date
- 2 Jul 2024
- Primary completion date
- Jul 2025
- Lead sponsor
- AAVantgarde Bio Srl
- Diseases
- Retinitis pigmentosa
- NCT number
- NCT06591793
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 15
- From 2 Jul 2024 to the primary completion date, Jul 2025
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous participation in another Gene Therapy trial
Other illness
- Any condition that would preclude subretinal surgery
- Complicating ocular and/or systemic diseases
Other
- Unwillingness to meet the requirements of the study
- Participation in a clinical study with an Investigation Product in the past 6 months
Who the study is looking for
- Molecular diagnosis of USB1B due to MYO7A mutation
- Willingness to adhere to protocol per informed consent
Age in the registry: 18 years to 50 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Retina Clinic London Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Moorfields Eye Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| University of Campania "Luigi Vanvitelli" Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.