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LUNA - SB-421a-006 - Clinical Trial

¿Cuál es el Propósito de este estudio?

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.

¿Cuál es la Condición que se está estudiando?

Retinitis pigmentaria

¿Quién puede participar en el Estudio?

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.

Grupo etario
Adultos, Niños

¿Qué Implica?

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.

Detalles del Estudio

Título Completo
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
Investigador Principal
Oleg Alekseev, MD, PhD
Especialista en oftalmología
Número de Protocolo
IRB: PRO00118825
NCT: NCT06627179
Fase
Phase II
ClinicalTrials.gov
Estado de inscripción
Pronto disponible para inscripción
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Contribuya a Duke Health