drugset / Trial / NCT02862938

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

NCT02862938 ↗

Phase 2 Active not recruiting 54 enrolled Stanford University
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2016-06
Primary completion
2025-08-15
Completion
2026-08-15

Drugs

EvaluationDrugModalityDoseRoute
Subject NT-501 ECT Unknown — Intravitreal

Indications