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Study of NT-501 Encapsulated Cell Therapy for Glaucoma Neuroprotection and Vision Restoration
Sponsor: Stanford University
Summary
This is a randomized, sham controlled, masked clinical trial of 60 study participants with glaucoma. Participants with a qualifying study eye will be randomized after screening and baseline evaluations to receive the NT-501 encapsulated cell therapy (ECT) implant or a sham surgery (control arm), and no explant will be required. An examination for safety will occur one day and one week following implant and periodically thereafter for 24 months post-implant. Based on the primary analysis of data at 6 months, patients in the control arm may be offered the NT-501 ECT implant at the 12 month time point.
Official title: A Randomized, Sham Controlled, Masked Phase II Study to Evaluate the Safety and Efficacy of Intravitreal Implantation of NT-501 Encapsulated Cell Therapy for the Treatment of Glaucoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
54
Start Date
2016-06
Completion Date
2026-08-15
Last Updated
2025-11-04
Healthy Volunteers
No
Conditions
Interventions
NT-501 ECT implant
NT-501 ECT implant will be placed into the vitreous and out of the visual axis of the study eye. The surgical procedure involves making a small incision through the sclera (white part of the eye), inserting the implant and securing it with a suture.
Sham
Sham surgery
Locations (1)
Byers Eye Institute at Stanford University
Palo Alto, California, United States