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

Recruiting Phase 1 Phase 2 Interventional Study
Geographic Atrophy (GA) Secondary to Dry Age-related Macular Degeneration (AMD)
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.
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At a Glance
Age
50 – 85
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Bionic Sight LLC · Industry
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About This Trial
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 P…
Trial Locations
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Eligibility Criteria
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 secon…
Contacts

Sheila Nirenberg, PhD+

1+9178425027

snsheilan@gmail.com

CONTACT