BS01 in Patients With Retinitis Pigmentosa
ConditionRetinitis Pigmentosa
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBionic Sight LLC
About this trial
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
This trial does not accept healthy volunteersQualifiers
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°.
Disqualifiers
Prior receipt of any AAV gene therapy product
Large amplitude nystagmus
Trial design
Design model
Sequential
Treatments tested in this trial
BS01
DrugNon-replicating, rep/cap-deleted, recombinant adeno-associated virus vector expressing an enhanced light-sensitive channelrhodopsin gene (ChronosFP)
Treatment groups
20 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Cohort 1Experimental treatment 1 intervention
Group B: Cohort 2Experimental treatment 1 intervention
Group C: Cohort 3Experimental treatment 1 intervention
Group D: Cohort 4Experimental treatment 1 intervention
Group E: Cohort 5Experimental treatment 1 intervention
Group F: Cohort 6Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Primary Outcome Measure
Number of subjects with adverse events, changes in hematology/chemistry
Time frame
12 monthsSecondary outcomes
1
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 monthsSponsors and contacts
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Source ClinicalTrials.gov