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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: Recruiting Phase 1 study of Geographic Atrophy (GA) Secondary to Dry Age-related Macular Degeneration (AMD), sponsored by Bionic Sight.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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 |
What NCT07158775 shows while recruiting
NCT07158775 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07158775's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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