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.
Who Can Participate?
Eligibility
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 Range
12-50
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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).
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
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
Maldonado
Protocol Number
PRO00118889
Phase
II
Enrollment Status
Pending Open to Enrollment