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Ciliary Neurotrophic Factor (CNTF) has been demonstrated in multiple preclinical models to enhance survival and regeneration of retinal ganglion cells, the retinal neurons injured in diseases like ischemic optic neuropathy/optic nerve stroke. We hypothesize that CNTF delivery to the human eye will provide neuroprotection (prevent loss of vision) and neuroenhancement (improve vision indices) in ischemic optic neuropathy. Patients in the trial will receive an NT-501 CNTF implant (made by Neurotech) into one eye, and will be carefully followed to evaluate safety and efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NT-501 CNTF Implant | Experimental | Patients will receive single NT-501 CNTF implant in one eye |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NT-501 CNTF Implant | Drug | Single implantation of CNTF-secreting NT-501 device into one eye |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Number of patients with adverse events | Safety will be evaluated by determining the number of patients with adverse events, including loss of vision, visual field, or retinal/optic nerve structure, and ocular complications such as pain and inflammation. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Efficacy: Vision, Visual Field, Pattern Electroretinogram, Visual Field Questionnaire-25 | 18 months | |
| Structural efficacy: Nerve fiber layer, optic nerve topography | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bascom Palmer Eye Institute, University of Miami Miller School of Medicine | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D018917 | Optic Neuropathy, Ischemic |
| ID | Term |
|---|---|
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
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| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |