Gene therapy for patients with retinitis pigmentosa

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a non-randomized, open-label Phase 1/2 dose escalation study evaluating BS01, a recombinant adeno-associated virus vector designed to express an enhanced light-sensitive channelrhodopsin gene. The study aims to assess the safety and efficacy of BS01 in patients diagnosed with retinitis pigmentosa who have bare light perception in at least one eye. Participants will receive varying doses of the treatment to determine the optimal dosage for therapeutic effect.

Why it matters

Who can join: the full rules

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

Where it's running

• New Jersey Retina
  Teaneck, New Jersey, United States Recruiting

Study contacts

• Study coordinator: Minako Koga
• Email: mkoga@kmphc.com

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.