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Virus Therapy

Gene Therapy for Retinitis Pigmentosa

Phase 1 & 2
Recruiting
Research Sponsored by Bionic Sight LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Confirmed diagnosis of retinitis pigmentosa
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial is testing a new gene therapy for retinal degeneration that uses a virus to deliver the gene.

Who is the study for?
This trial is for individuals with confirmed retinitis pigmentosa who have very limited vision, described as 'bare light perception', in at least one eye. It's not open to those who've previously received any AAV gene therapy or have large amplitude nystagmus, which is a condition where the eyes make repetitive, uncontrolled movements.Check my eligibility
What is being tested?
The study involves BS01, a genetic treatment using a modified virus to deliver genes into cells of the eye. This early-phase trial will test different doses to see how safe it is and what effects it has on patients' vision.See study design
What are the potential side effects?
As this is an early-stage trial for BS01, specific side effects are being studied; however, potential risks may include immune reactions to the viral vector or inflammation in the eye.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with retinitis pigmentosa.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Measure
Secondary outcome measures
Measures

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort 4Experimental Treatment1 Intervention
BS01 Cohort4 dose
Group II: Cohort 3Experimental Treatment1 Intervention
BS01 Cohort 3 dose
Group III: Cohort 2Experimental Treatment1 Intervention
BS01 Cohort 2 dose
Group IV: Cohort 1Experimental Treatment1 Intervention
BSO1 Cohort 1 dose

Find a Location

Who is running the clinical trial?

Bionic Sight LLCLead Sponsor
Sheila Nirenberg, PhDStudy DirectorBionic Sight LLC

Media Library

BS01 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04278131 — Phase 1 & 2
Retinitis Pigmentosa Research Study Groups: Cohort 2, Cohort 1, Cohort 3, Cohort 4
Retinitis Pigmentosa Clinical Trial 2023: BS01 Highlights & Side Effects. Trial Name: NCT04278131 — Phase 1 & 2
BS01 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04278131 — Phase 1 & 2
Retinitis Pigmentosa Patient Testimony for trial: Trial Name: NCT04278131 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities for individuals to participate in this experiment?

"Clinicaltrials.gov indicates that this medical trial is presently recruiting volunteers; the initial posting was on February 6th 2020 and it has been modified as of November 2nd 2021."

Answered by AI

How many participants is this trial accommodating at its maximum capacity?

"Affirmative. According to clinicaltrials.gov, this experiment is presently recruiting patients who meet the inclusion criteria. It was first published on February 6th 2020 and underwent its last update November 2nd 2021; currently seeking 20 participants at a single site."

Answered by AI

Who else is applying?

What state do they live in?
Puerto Rico
New York
Other
Florida
How old are they?
65+
18 - 65
What site did they apply to?
OCLI
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
0

Why did patients apply to this trial?

I’d do anything I could to help find something to help us all. Me, and my twin sister, both suffer from a deteriorating RP. We're seeking a clinical trial that can potentially alleviate our condition.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
BS01 in Patients With Retinitis Pigmentosa
2020. "BS01 in Patients With Retinitis Pigmentosa". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04278131.
All > Retinitis Pigmentosa New York > Retinitis Pigmentosa
~3 spots leftby Dec 2024
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