Actively Recruiting
A Phase 1/2 Study to Evaluate the Safety and Efficacy of Intravitreal Administration of BS01 in Patients With Geographic Atrophy Secondary to Dry AMD
Led by Bionic Sight LLC · Updated on 2026-01-23
40
Participants Needed
1
Research Sites
307 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase 1/2 Study to Evaluate the Safety and Efficacy of Intravitreal Administration of BS01 in Patients With Geographic Atrophy Secondary to Dry AMD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before screening
- Men or women aged 50 to 85 years inclusive
- Geographic atrophy with some macula foveal involvement due to dry AMD
- Total GA area between 5 and 17.5 mm2 measured by specialized imaging
- At least one focal lesion 1.25 mm2 if GA is multifocal
- Composite lesion area meeting specified thresholds
- GA located partly within 1200 microns of the foveal center
- Atrophic lesion can be fully photographed
- Best corrected visual acuity (BCVA) between 20/50 and 20/400 inclusive
- Clear ocular media and adequate pupil dilation for imaging
- Central fixation ability
You will not qualify if you...
- Previous therapeutic radiation in the study eye region
- Prior treatment with any ocular or systemic gene transfer product
- Use of any investigational agent within 60 days
- Pregnant or nursing women
- Known allergy to topical ocular anesthetics or diagnostic drops
- Any medical condition interfering with protocol compliance or safety
- More than 30% BCVA difference between two baseline tests 14 days apart
- Intraocular surgery or thermal laser within 3 months before study
- History of posterior vitrectomy, glaucoma surgery, corneal transplant, or retinal detachment
- Ocular or periocular infection or inflammation within past 12 weeks
- Signs of diabetic retinopathy in either eye
- Intraocular pressure over 25 mmHg in either eye
- Completely atrophic central lesions based on imaging
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
NJ Retina
Edison, New Jersey, United States, 08820
Actively Recruiting
Research Team
S
Sheila Nirenberg, PhD+
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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