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Ciliary Neurotrophic Factor (CNTF) has been demonstrated in multiple pre-clinical models to enhance survival and regeneration of retinal ganglion cells, the retinal neurons injured in diseases like glaucoma. We hypothesize that CNTF delivery to the human eye will provide neuroprotection (prevent loss of vision) and neuroenhancement (improve vision indices) in glaucoma. 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 adverse events | Safety will be evaluated by counting 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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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey L Goldberg, MD, PhD | Bascom Palmer Eye Institute, University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bascom Palmer Eye Institute, University of Miami | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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