A Phase 1/2 interventional study of AAVB-081 in Usher Syndrome, Type 1B, sponsored by AAVantgarde Bio Srl. Recruiting at 3 sites in 2 countries. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-05-02.
Sponsored by AAVantgarde Bio Srl · Phase 1/2, Interventional, and Treatment
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.
33 studies on the registry are indexed under Usher Syndromes; 13 are open to participants now.
This study's planned enrollment of 15 is below the median of 39 across 18 interventional studies indexed under Usher Syndromes.
Browse Usher Syndromes studies →AAVantgarde Bio Srl is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
AAVB-081 dose level 1
Biological: AAVB-081
AAVB-081 dose level 2
Biological: AAVB-081
AAVB-081 dose level 3
Biological: AAVB-081
Single subretinal administration
To measure the number and severity of treatment related adverse events following treatment with AAVB-081
Time frame: 61 months
Change from baseline in microperimetry following treatment with AAVB-081
Time frame: 61 months
Change from baseline in static perimetry following treatment with AAVB-081
Time frame: 61 months
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2024 (actual). Primary completion is estimated for Jul 2025, 12 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
AAVantgarde Bio Srl