Open for Enrollment Soon
This study will open for enrollment soon. Please contact the study team for more information and check back frequently.

LUNA - SB-421a-006 - Clinical Trial

What is the Purpose of this Study?

If you take part in this study, you will visit the clinic at least ten times over about twenty seven months. Most visits will last two days, but some may take three days if needed. You will be placed into one of two groups by chance. One group will receive the study medicine, and the other group will receive a sham injection, which looks like a real injection but has no medicine.

What is the Condition Being Studied?

Retinitis Pigmentosa

Who Can Participate in the Study?

People can join this study if they are older than 8 years or are adults. Both eyes must show signs of a vision disease called retinitis pigmentosa. They cannot have had eye injections in the past.

Age Group
Adults, Children

What is Involved?

This study is testing a new medicine called ultevursen. It is designed to help people who have a vision disease called retinitis pigmentosa caused by a specific genetic change called a USH2A exon 13 mutation. Researchers want to learn if this medicine is safe and if it can help slow down or improve vision loss.

Study Details

Full Title
A Two-Year Double-masked, Randomized, Sham-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Ultevursen in Subjects with Retinitis Pigmentosa (RP) due to Mutations in Exon 13 of the USH2A Gene - SB-421a-006 - LUNA
Principal Investigator
Oleg Alekseev, MD, PhD
Ophthalmologist
Protocol Number
IRB: PRO00118825
NCT: NCT06627179
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment Soon
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