Study of Subretinally Injected AAVB-081 in Patients With Usher Syndrome Type IB (USH1B) Retinitis Pigmentosa
Recruiting
Phase 1
Phase 2
Interventional Study
Usher Syndrome, Type 1B
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 50
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 15 (estimated)
- Sponsor
- AAVantgarde Bio Srl · Industry
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About This Trial
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Molecular diagnosis of USB1B due to MYO7A mutation
* Willingness to adhere to protocol per informed consent
Exclusion Criteria:
* Unwillingness to meet the requirements of the study
* Participation in a clinical study with an Investigation Product in the past 6 months
* Prev…
Contacts