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Ultevursen for Vision Impairments
Study Summary
This trial will test if a new treatment for Retinitis Pigmentosa is safe and effective.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am willing and able to follow the study's requirements and attend all visits.I have been diagnosed with RP, either with Usher syndrome type 2 or the nonsyndromic form.I have a genetic condition linked to specific mutations in the USH2A gene.You have a BCVA between 30 and 68 letters (approximate Snellen equivalent 20/250 - 20/50) in the treatment eye.I am 18 or older, or between 12 and 17 with parental consent.I am willing and able to follow the study's requirements and attend all visits.I have RP with Usher syndrome type 2 or a form of RP without other symptoms, confirmed by eye and ear tests.I haven't used any experimental drugs or devices recently and don't plan to during the study.I am 18 or older, or between 12 and 17 with parental consent.I have a specific genetic mutation in the USH2A gene.I have never had genetic or stem-cell therapy for any condition.You are allergic to the injection or any of its ingredients.
- Group 1: Ultevursen 180/60 µg
- Group 2: Ultevursen 60/60 µg
- Group 3: Sham-procedure
- 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.
Frequently Asked Questions
Can new patients sign up for this clinical trial?
"Unfortunately, this specific study is not recruiting at the moment. According to clinicaltrials.gov, it was last edited on September 15th, 2022 and originally posted December 8th, 2021. There are 1258 other trials that may be of interest and are currently looking for patients."
How many different hospitals or research facilities are conducting this experiment?
"Patients are being accepted at 11 different locations for this clinical trial. Some of these sites include Columbia University in New york, New York, Shiley Eye Institute - UC San Diego in San Diego, California, and University of California, San Francisco in San Francisco, Florida."
What are the goals that this clinical trial is hoping to achieve?
"The primary goal of this experiment, which will be conducted over the course of 18 months and pit treatment against a sham procedure, is to evaluate changes in BCVA from baseline. Additionally, we will also be looking at Cmax of ultevursen in serum, change from baseline in ellipsoid zone (EZ) area and width as imaged by spectral domain optical coherence tomography (SD-OCT), and exposure of QR-421a in serum."
Who else is applying?
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How old are they?
What portion of applicants met pre-screening criteria?
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How many prior treatments have patients received?
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