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Dual Intravitreal Implantation of NT-501 Encapsulated Cell Therapy for Glaucoma

Glaucoma Clinical Trial

Official title:
A Randomized, Sham Controlled, Masked Phase II Study to Evaluate the Safety and Efficacy of Dual Intravitreal Implantation of NT-501 Encapsulated Cell Therapy for the Treatment of Glaucoma

Clinical Trial Summary

To determine the safety and efficacy over 24 months of dual NT-501 CNTF encapsulated cell therapy (ECT) on visual impairment related to glaucoma.

Clinical Trial Description

A randomized, sham controlled, masked trial of up to 30 eyes will be recruited into the study. Participants with a qualifying study eye will be randomized after screening and baseline evaluations to receive 2 NT-501 ECT implants in the study eye (20 eyes), 1 NT-501 ECT implant (5 eyes) or a sham surgery (control arm; 5 eyes). 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. Patients in the control arm may be offered 2 NT-501 ECT implants after the 12-month post-operative follow-up visit. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04577300
Study type Interventional
Source Stanford University
Contact Mariana Nunez, MD
Phone 6504977846
Email mnunez@stanford.edu
Status Recruiting
Phase Phase 2
Start date May 15, 2021
Completion date December 15, 2024
View Details
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