LANDSCAPE - RPGR-005 - Clinical Trial

What is the Purpose of this Study?

People in this study will have two eye surgeries. The study medicine will be placed in the back part of the eye, where the retina is. First, only one eye will have surgery. The second eye will have surgery either 30 to 60 days later, or 7 to 14 days later, depending on when the person joins the study.

They will also take steroid medicine and use eye drops. After the surgeries, doctors will check on them for about 5 years to see how they are healing and how well the medicine works.

What is the Condition Being Studied?

X-linked Retinitis Pigmentosa

Who Can Participate in the Study?

People in this study must:

- Be boys or men between 12 and 50 years old.

- Have a medical condition called X-linked retinitis pigmentosa (XLRP), which affects their eyes.

- Not be allergic to certain medicines called corticosteroids or other drugs that lower the immune system.

Age Group
Adults, Children

What is Involved?

This study is trying to find out if a new medicine called laruparetigene zovaparvovec (also called AGTC-501) is safe and can help people see better or keep their vision from getting worse. The medicine is given through surgery in both eyes to help people who have a rare eye disease called X-linked retinitis pigmentosa (XLRP).

Study Details

Full Title
A Phase 2 Open-label Study to Evaluate the Safety of Laruparetigene Zovaparvovec Administered Bilaterally in Male Participants with X-Linked Retinitis Pigmentosa - RPGR-005 - LANDSCAPE
Principal Investigator
Ramiro S. Maldonado, MD
Ophthalmologist
Protocol Number
IRB: PRO00118889
NCT: NCT07174726
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
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