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.
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
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
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
Loading…
Loading trial locations…
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