A PROSPECTIVE FIRST-IN-HUMAN STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF QR-1123 IN SUBJECTS WITH AUTOSOMAL DOMINANT RETINITIS PIGMENTOSA (adRP) DUE TO THE P23H MUTATION IN THE RHO GENE

Primary Objective

The purpose of this study is to find out if different dose levels (amounts) of the study drug are safe. This study will also measure whether the study drug improves your vision.

Study category: Eyes

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Description

Currently there is no approved treatment for Retinitis Pigmesntosa due to the P23H mutation. The study drug is designed to repair the problem that causes vision loss due to this mutation.

Main Procedures Involved: At each study visit, you will be asked about your health and several study assessments and tests will be performed.

Duration of Participation: Your participation will last for 12 months (1 year) from the time you will receive the study treatment. If you decide to take part in the study, you will have to visit the study site 9 to 13 times. It is possible that some of these visits will be planned on multiple consecutive days. You may need to stay overnight near the study site. You may bring someone with you. In exceptional cases, e.g. related to restrictions related to the COVID-19 pandemic, part of your visit may be performed by phone and/or the visit at your study site may be postponed to a later date.

Details
Age

18 to 100 years

Type of Study

Treatment

Principal Investigator
Marc Mathias,  MD

Marc Mathias, MD

Study ID

Protocol Number: 19-2294

More information available at ClinicalTrials.gov: NCT04123626

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