Status:
NOT_YET_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
Lead Sponsor:
Bionic Sight LLC
Conditions:
Geographic Atrophy (GA) Secondary to Dry Age-related Macular Degeneration (AMD)
Eligibility:
All Genders
50-85 years
Phase:
PHASE1
PHASE2
Brief 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-expansio...
Eligibility Criteria
Inclusion
- General Inclusion Criteria
- Signed informed consent obtained before screening.
- Men or women between 50 and 85 years of age inclusive at the time of signing the informed consent.
- Ophthalmic Inclusion Criteria
- Geographic atrophy with some macula foveal involvement secondary to dry AMD.
- Total GA area ≥ 5 and ≤ 17.5 mm2 (2 and 7 disk areas respectively), based on Heidelberg Region Finder or equivalent automated software.
- 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 evaluation.
- Composite lesion encompassing confluent GA regions with total area meeting thresholds given in 2 above.
- GA in part within 1200 microns from the foveal center.
- The atrophic lesion must be able to be photographed in its entirety.
- BCVA between 20/50 to 20/400, inclusive, using letter score per EDTRS chart.
- Clear ocular media and adequate pupillary dilatation in both eyes to allow for all imaging procedures, including good quality stereoscopic fundus photography and fundus autofluorescence (FAF).
- Central fixation.
Exclusion
- General Exclusion Criteria
- Previous therapeutic radiation in the region of the SE.
- Previous treatment with any ocular or systemic gene transfer product.
- Any treatment with an investigational agent in the past 60 days for any condition.
- Women who are pregnant or nursing.
- Known hypersensitivity to topical ocular anesthetics or diagnostic drops to be used during the study.
- Any other medical condition, which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromises patient safety, or interferes with the interpretation of the study results.
- Ophthalmic Exclusion Criteria
- \> 30% difference of BCVA using EDTRS in two baseline visual acuity assessments with at least 14 days apart during screening.
- Any intraocular surgery or thermal laser within 3 months of study entry. Any prior thermal laser in the macular region, regardless of indication.
- Any ocular or periocular infection (including blepharitis), or ocular surface inflammation in the past 12 weeks.
- History of any of the following procedures: Posterior vitrectomy, filtering surgery (e.g., trabeculectomy), glaucoma drainage device, corneal transplant, or retinal detachment.
- Any sign of diabetic retinopathy in either eye.
- Intraocular pressure (IOP) \> 25 mmHg in either eye.
- Completely atrophic centrally located lesions based on ellipsoid zone (EZ) loss in spectraldomain optical coherence tomography (SD-OCT).
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2031
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07158775
Start Date
November 1 2025
End Date
December 1 2031
Last Update
September 8 2025
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