To determine the safety and efficacy over 24 months of dual NT-501 CNTF encapsulated cell therapy (ECT) on visual impairment related to glaucoma.
A randomized, sham controlled, masked trial of up to 30 eyes will be recruited into the study. Participants with a qualifying study eye will be randomized after screening and baseline evaluations to receive 2 NT-501 ECT implants in the study eye (20 eyes), 1 NT-501 ECT implant (5 eyes) or a sham surgery (control arm; 5 eyes). No explant will be required. An examination for safety will occur one day and one week following implant and periodically thereafter for 24 months post-implant. Patients in the control arm may be offered 2 NT-501 ECT implants after the 12-month post-operative follow-up visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
Implant of Neurotech NT-501 device(s)
Sham implantation
Byers Eye Institute at Stanford University
Palo Alto, California, United States
Visual Field MD at 12 Months
Change from baseline in visual field through 12 months as assessed by Mean Deviation (MD).
Time frame: 12 months
Visual Field Index at 12 months
Change from baseline in visual field through 12 months as assessed by Visual Field Index (VFI).
Time frame: 12 months
Visual Field PLR at 12 months
Change from baseline in visual field pointwise linear regression (PLR) through 12 months.
Time frame: 12 months
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