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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NT-501 ECT Implant | Experimental | On eligible participants that are randomized to this group, the NT-501 Investigational product will be implanted in the study eye, and participants will be followed for 24 months. The investigational treatment, NT-501 ECT, provides intravitreal sustained release of soluble ciliary neurotrophic factor (CNTF) receptor after intraocular implantation. |
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| Sham | Sham Comparator | To maintain masking, participants randomized to this group receive sham surgery and will be followed for 12 months. Following analysis of the 6 month data, if the open label extension (OLE) is not triggered, patients in the control group will continue on the original study schedule timeline trough month 24. If OLE is triggered participants will be offered the NT-501 ECT investigational product and will followed for additional 12 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NT-501 ECT implant | Drug | NT-501 ECT implant will be placed into the vitreous and out of the visual axis of the study eye. The surgical procedure involves making a small incision through the sclera (white part of the eye), inserting the implant and securing it with a suture. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Field | 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:
| 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Structural measure of retinal ganglion cell layer thickness | The change in ganglion cell layer thickness as measured by spectral domain optical coherence tomography (sdOCT). | 6, 12 and 24 months |
| Structural measure of retinal nerve fiber layer thickness |
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Inclusion Criteria:
Patients must meet all of the following criteria to join the study (all eligibility criteria must be met at the screening and baseline visits unless otherwise noted):
Participant must be medically able to undergo the testing required in the schedule of events (SOE).
Participant's clinical diagnosis must be consistent with glaucoma 1. characterized by the following features:
a) Clinical evidence of progressive retinal ganglion cell (RGC) dysfunction and degeneration using both visual field and at least one structural modality as established by: i. Glaucomatous visual field abnormality. ii. Mean deviation (MD) of -3 to -15 dB. iii. Minimum average retinal nerve fiber layer (RNFL) thickness of 60 μm and maximum average RNFL of 90 μm.
b) Residual visual field preservation including best-corrected visual acuity (BCVA) better than 20/200 in both eyes.
c) Two visual field tests of adequate quality with a maximum visual field index (VFI) variability of ± 10%.
Participant's glaucoma must be clinically stable, with intraocular pressure (IOP) < 21.
If a participant has two eyes meeting study criteria, only the worse eye as determined by visual field index (VFI) will be deemed includable. If both eyes qualify and have the same VFI, a randomization procedure will assign one eye to the study.
Participant must understand and sign the informed consent. If the participant's vision is impaired to the point where he/she cannot read the informed consent document, the document will be read to the participant in its entirety.
Females of childbearing potential must agree to use an effective form of birth control.
Participant must be determined by the presurgical anesthesia or medical team to be fit for ophthalmic surgery for the NT-501 ECT implant insertion.
Exclusion Criteria:
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| 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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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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| Sham | Other | Sham surgery |
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The change in retinal nerve fiber layer thickness as measured by spectral domain optical coherence tomography (sdOCT). |
| 6, 12 and 24 months |
| Contrast sensitivity | The change in contrast sensitivity through 6, 12 and 24 months | 6, 12 and 24 months |
| Best corrected visual acuity | The change in best corrected visual acuity (BCVA) through 6, 12 and 24 months | 6, 12 and 24 months |
| Optic nerve head structural change | The change in optic nerve topography as measured by stereo photography through 6, 12, or 24 months 6. The change in visual field as measured by pattern standard deviation (PSD) through 6 months 7. The change in any of the above functional or structural measures at 12 or 24 months | 6, 12 and 24 months |
| Visual field pattern standard deviation | The change in visual field as measured by pattern standard deviation (PSD) through 6, 12 or 24 months 7. The change in any of the above functional or structural measures at 12 or 24 months | 6, 12 and 24 months |