drugset / Trial / NCT02862938
Study of NT-501 Encapsulated Cell Therapy for Glaucoma Neuroprotection and Vision Restoration
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NT-501 ECT | Unknown | — | Intravitreal |