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NCT07158775 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Geographic Atrophy (GA) Secondary to Dry Age-related Macular Degeneration (AMD), sponsored by Bionic Sight.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT07158775 is a Phase 1 study of Geographic Atrophy (GA) Secondary to Dry Age-related Macular Degeneration (AMD) that is actively recruiting participants, run by Bionic Sight. The registered enrollment target is 40 participants. The trial reports 1 study location across 1 state.
The verdict
NCT07158775, a Phase 1 study of Geographic Atrophy (GA) Secondary to Dry Age-related Macular Degeneration (AMD), is actively recruiting participants, sponsored by Bionic Sight.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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.
Interventions
- BIOLOGICAL BS01
- OTHER Sham procedure control
Study Locations (1)
New Jersey
- NJ Retina - Edison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2026-01-08 |
| Est. Completion | 2031-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07158775
The ClinicalTrials.gov registry entry for NCT07158775 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bionic Sight, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Geographic Atrophy (GA) Secondary to Dry Age-related Macular Degeneration (AMD) appearing as the primary indexed condition, and to 2 interventions - of which BS01 is the first listed.
NCT07158775 reports 1 study location spanning 1 distinct geographic area - top geographies include New Jersey.
Frequently Asked Questions
What is clinical trial NCT07158775 about?
NCT07158775 is a clinical study titled "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". 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...
What is the current status of trial NCT07158775?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2026-01-08. Estimated completion is 2031-12.
What conditions does trial NCT07158775 study?
This clinical trial studies the following conditions: Geographic Atrophy (GA) Secondary to Dry Age-related Macular Degeneration (AMD).
What interventions are being tested in trial NCT07158775?
The interventions under investigation include: BS01 (BIOLOGICAL), Sham procedure control (OTHER).
Who is sponsoring clinical trial NCT07158775?
This trial is sponsored by Bionic Sight, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07158775 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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