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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Confirmed diagnosis of retinitis pigmentosa
Bare light perception in at least one eye
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up12 months
Awards & highlights
No Placebo-Only Group
Study Summary
This trial is testing a new gene therapy for retinal degeneration that uses a virus to deliver the gene.
Eligible Conditions
- Retinitis Pigmentosa
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have very limited or no vision in at least one eye.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have very limited or no vision in at least one eye.You have previously received any type of AAV gene therapy product.You can only see very minimal light with at least one eye.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 4
- Group 2: Cohort 1
- Group 3: Cohort 3
- Group 4: Cohort 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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