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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Single implantation of CNTF-secreting NT-501 device into one eye
Bascom Palmer Eye Institute, University of Miami
Miami, Florida, United States
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.
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
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