A Phase 1/2 Study to Evaluate the Safety and Efficacy of Intravitreal Administration of BS01, a Recombinant Adeno-Associated Virus Vector Expressing ChronosFP (AAV2-CAGChronosFP) in Patients With Geographic Atrophy Secondary to Dry AMD
Bionic Sight LLC
Summary
This is a Phase 1/2 study, multi-center, dose-escalation interventional study of BS01 in subjects with GA secondary to dry AMD. Part 1 is an open label dose-escalation study; Part 2 is a dose-expansion study with dose(s) selected from Part 1 based on a benefit/risk assessment, and an untreated (sham injection) group to allow for a controlled comparison of efficacy and safety. This is a seamless Phase 1/2 study in up to 10 patients for Phase 1 and 30 patients Phase 2 in patients with GA secondary to dry AMD.
Eligibility
- Age range
- 50–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: General Inclusion Criteria 1. Signed informed consent obtained before screening. 2. Men or women between 50 and 85 years of age inclusive at the time of signing the informed consent. Ophthalmic Inclusion Criteria 1. Geographic atrophy with some macula foveal involvement secondary to dry AMD. 2. Total GA area ≥ 5 and ≤ 17.5 mm2 (2 and 7 disk areas respectively), based on Heidelberg Region Finder or equivalent automated software. 3. If GA is multifocal, at least one focal lesion should measure ≥ 1.25 mm2 (0.5 disk area) to ensure measurable focal effects for efficacy eval…
Interventions
- BiologicalBS01
a recombinant adeno-associated virus vector expressing ChronosFP (AAV2-CAGChronosFP)
- OtherSham procedure control
Sham procedure without needle
Location
- NJ RetinaEdison, New Jersey