NCT04278131 BS01 in Patients With Retinitis Pigmentosa
| NCT ID | NCT04278131 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Bionic Sight LLC |
| Condition | Retinitis Pigmentosa |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2020-02-06 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2020-02-06 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A Phase 1/2, Safety and Efficacy Trial of BS01, a Recombinant Adeno-Associated Virus Vector Expressing ChronosFP (AAV2-CAG-ChronosFP) in Patients with Retinitis Pigmentosa
Eligibility Criteria
Inclusion Criteria: * Confirmed diagnosis of retinitis pigmentosa * At least one eye with vision no better than 20/160 visual acuity on the EDTRS scale or, for patients with peripheral vision loss, a visual field no greater than 30°. Exclusion Criteria: * Prior receipt of any AAV gene therapy product * Large amplitude nystagmus
Contact & Investigator
Minako Koga
✉ mkoga@kmphc.comSheila Nirenberg, PhD
STUDY DIRECTOR
Bionic Sight LLC
Frequently Asked Questions
Who can join the NCT04278131 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Retinitis Pigmentosa. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04278131 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04278131 currently recruiting?
Yes, NCT04278131 is actively recruiting participants. Contact the research team at mkoga@kmphc.com for enrollment information.
Where is the NCT04278131 trial being conducted?
This trial is being conducted at Teaneck, United States.
Who is sponsoring the NCT04278131 clinical trial?
NCT04278131 is sponsored by Bionic Sight LLC. The principal investigator is Sheila Nirenberg, PhD at Bionic Sight LLC. The trial plans to enroll 20 participants.