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ACTIVE NOT RECRUITING
NCT02862938
PHASE2

Study of NT-501 Encapsulated Cell Therapy for Glaucoma Neuroprotection and Vision Restoration

Sponsor: Stanford University

View on ClinicalTrials.gov

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

DRUG

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.

OTHER

Sham

Sham surgery

Locations (1)

Byers Eye Institute at Stanford University

Palo Alto, California, United States