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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
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.
Details
| Lead sponsor | Stanford University |
|---|---|
| Phase | Phase 2 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 54 |
| Start date | 2016-06 |
| Completion | 2026-08-15 |
Conditions
- Glaucoma
Interventions
- NT-501 ECT implant
- Sham
Primary outcomes
- Visual Field — 6 months
Determine the efficacy of NT-501 ECT implant in patients with glaucoma as measured by change in visual field through 6 months as assessed by any one of the following three indices: 1. Visual Field Index (VFI) 2. Mean Deviation (MD) 3. Pointwise linear regression (PLR)
Countries
United States