BS01 in Patients With Retinitis Pigmentosa

Phase 2RecruitingNCT04278131

Bionic Sight LLC20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Retinitis Pigmentosa

Interventions

BS01DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

New Jersey Retina

Teaneck, New Jersey, United States

RECRUITING

Outcomes

Primary Outcomes

Primary Outcome Measure

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

Time frame: 12 months

Secondary Outcomes

Secondary Outcome Measures

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

Time frame: 12 months

Central Contacts

Minako Koga

CONTACT

mkoga@kmphc.com

Data from ClinicalTrials.gov

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