NT-501 CNTF Implant for Glaucoma: Safety, Neuroprotection and Neuroenhancement
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 Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||CNTF Cell Implants For Glaucoma: A Phase I Study|
- Safety: Number of adverse events [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]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.
- Functional Efficacy: Vision, Visual Field, Pattern Electroretinogram; Visual Field Questionnaire-25 [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
- Structural Efficacy: Nerve fiber layer, optic nerve topography [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: NT-501 CNTF Implant
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
|United States, Florida|
|Bascom Palmer Eye Institute, University of Miami|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Jeffrey L Goldberg, MD, PhD||Bascom Palmer Eye Institute, University of Miami|