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RECRUITING
NCT07158775
PHASE1/PHASE2

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

Sponsor: Bionic Sight LLC

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

50 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-01-08

Completion Date

2031-12

Last Updated

2026-01-23

Healthy Volunteers

No

Interventions

BIOLOGICAL

BS01

a recombinant adeno-associated virus vector expressing ChronosFP (AAV2-CAGChronosFP)

OTHER

Sham procedure control

Sham procedure without needle

Locations (1)

NJ Retina

Edison, New Jersey, United States