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

GR44251 - GAlette (Geographic Atrophy Secondary to Age-Related Macular Degeneration) - Clinical Trial

What is the 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.

What is the Condition Being Studied?

Geography Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)

Who Can Participate in the Study?

Adults ages 50+ who:

  • Are diagnosed with GA secondary to AMD
  • Have never received stem cell treatments or gene therapy for their eyes

For more information, contact the study team at victoria.griffiths@duke.edu.

Age Group
Adults

What is Involved?

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.

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, MD
Ophthalmologist
Protocol Number
IRB: PRO00118048
NCT: NCT05626114
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment Soon
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