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NCT Number: NCT04278131

BS01 in Patients With Retinitis Pigmentosa

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

Recruiting

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Key information

Conditions

Retinitis Pigmentosa Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Retinal Degeneration Retinal Diseases Retinal Dystrophies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

New Jersey Retina

Teaneck, New Jersey, 07666, United States

Location status: Recruiting

Location contact

Lauryn Onkendi

CONTACT

[email protected]

(201)837-7300 ext. opt. 4

Paul Hahn, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BS01

Drug

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

Primary outcomes

  1. Primary Outcome Measure

    Time frame: 12 months

    Number of subjects with adverse events, changes in hematology/chemistry

Secondary outcomes

  1. Secondary Outcome Measures

    Time frame: 12 months

    Changes in light detection (threshold to detect) Changes in motion detection Changes in shape/object/letter detection Changes in performance on maze navigation task

Study contacts

Contact information is provided by the study sponsor or research team.

Minako Koga

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Bionic Sight LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2029
First posted
Feb 20, 2020
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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