A Phase 1 interventional study of NT-501 CNTF Implant in Ischemic Optic Neuropathy/Optic Nerve Stroke, sponsored by Jeffrey L Goldberg. Completed at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2016-08-02.
Sponsored by Jeffrey L Goldberg · Phase 1, Interventional, and Treatment
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.
128 studies on the registry are indexed under Optic Nerve Diseases; 27 are open to participants now.
This study's enrollment of 11 is below the median of 40 across 84 interventional studies indexed under Optic Nerve Diseases.
Browse Optic Nerve Diseases studies →Jeffrey L Goldberg is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Patients will receive single NT-501 CNTF implant in one eye
Drug: NT-501 CNTF Implant
Single implantation of CNTF-secreting NT-501 device into one eye
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.
Time frame: 18 months
Functional Efficacy: Vision, Visual Field, Pattern Electroretinogram, Visual Field Questionnaire-25
Time frame: 18 months
Structural efficacy: Nerve fiber layer, optic nerve topography
Time frame: 18 months
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Jeffrey L Goldberg