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To determine the safety and efficacy over 24 months of dual NT-501 CNTF encapsulated cell therapy (ECT) on visual impairment related to glaucoma.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dual Implantation | Experimental | Two NT-501 devices will be implanted in the study eye. |
|
| Single Implantation | Experimental | One NT-501 device will be implanted in the study eye. |
|
| Sham Implantation | Sham Comparator | No NT-501 devices will be implanted in the study eye. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NT-501 | Drug | Implant of Neurotech NT-501 device(s) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Field MD at 12 Months | Change from baseline in visual field through 12 months as assessed by Mean Deviation (MD). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Field Index at 12 months | Change from baseline in visual field through 12 months as assessed by Visual Field Index (VFI). | 12 months |
| Visual Field PLR at 12 months | Change from baseline in visual field pointwise linear regression (PLR) through 12 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey L Goldberg, MD, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Byers Eye Institute at Stanford University | Palo Alto | California | 94303 | United States |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| Sham comparator |
| Other |
Sham implantation |
|
| 12 months |