RecruitingPhase 1Phase 2NCT04278131

BS01 in Patients With Retinitis Pigmentosa

Phase 1/2, Safety and Efficacy Trial of BS01, a Recombinant Adeno-Associated Virus Vector Expressing ChronosFP in Patients With Retinitis Pigmentosa


Sponsor

Bionic Sight LLC

Enrollment

20 participants

Start Date

Feb 6, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 1/2 study is testing a gene therapy called BS01 — which delivers a light-sensitive protein called ChronosFP into the eye using a viral carrier — for patients with retinitis pigmentosa, a condition where the light-sensing cells in the retina progressively degenerate, leading to severe vision loss or blindness. The goal is to restore some light sensitivity in eye cells that have lost function, and the study will evaluate both safety and early signs of benefit. Adults or older patients with a confirmed retinitis pigmentosa diagnosis and vision no better than 20/160 in at least one eye are potentially eligible, while those who have previously received AAV gene therapy or have large eye movement disorders (nystagmus) are excluded. Participation involves receiving a single injection of BS01 into the eye and attending follow-up visits to monitor safety and vision over the study period. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBS01

Non-replicating, rep/cap-deleted, recombinant adeno-associated virus vector expressing an enhanced light-sensitive channelrhodopsin gene (ChronosFP)


Locations(1)

New Jersey Retina

Teaneck, New Jersey, United States

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NCT04278131


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