Purpose of this Study
We are doing this study to find out if an investigational drug called OpRegen (the study drug) is a safe and effective option for older adults who have geographic atrophy (GA) secondary to age-related macular degeneration (AMD). We also want to know if a procedure called subretinal surgical delivery is an effective way to give people the study drug.
Who Can Participate?
Eligibility
Adults ages 50+ who:
- Are diagnosed with GA secondary to AMD
- Have never received stem cell treatments or gene therapy for their eyes
Age Range
50-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will have the study drug delivered into the back of your eye through a surgical procedure. We will schedule you to come in for follow-up visits to check up on your eyes for up to 5 years after the procedure. There will be approximately 24 visits throughout the study.
During your study visits, you will have vision tests and eye exams.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A Phase IIa, Multicenter, Open-Label, Single-Arm Study to Optimize Subretinal Surgical Delivery and to Evaluate Safety and Activity of OpRegen in Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration - GR44251 (GAlette)
Principal Investigator
Lejla
Vajzovic
Protocol Number
PRO00118048
NCT ID
NCT05626114
Phase
II
Enrollment Status
Pending Open to Enrollment