This is a randomized, sham controlled, masked clinical trial of 60 study participants with glaucoma. Participants with a qualifying study eye will be randomized after screening and baseline evaluations to receive the NT-501 encapsulated cell therapy (ECT) implant or a sham surgery (control arm), and 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. Based on the primary analysis of data at 6 months, patients in the control arm may be offered the NT-501 ECT implant at the 12 month time point.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
54
NT-501 ECT implant will be placed into the vitreous and out of the visual axis of the study eye. The surgical procedure involves making a small incision through the sclera (white part of the eye), inserting the implant and securing it with a suture.
Sham surgery
Byers Eye Institute at Stanford University
Palo Alto, California, United States
Visual Field
Determine the efficacy of NT-501 ECT implant in patients with glaucoma as measured by change in visual field through 6 months as assessed by any one of the following three indices: 1. Visual Field Index (VFI) 2. Mean Deviation (MD) 3. Pointwise linear regression (PLR)
Time frame: 6 months
Structural measure of retinal ganglion cell layer thickness
The change in ganglion cell layer thickness as measured by spectral domain optical coherence tomography (sdOCT).
Time frame: 6, 12 and 24 months
Structural measure of retinal nerve fiber layer thickness
The change in retinal nerve fiber layer thickness as measured by spectral domain optical coherence tomography (sdOCT).
Time frame: 6, 12 and 24 months
Contrast sensitivity
The change in contrast sensitivity through 6, 12 and 24 months
Time frame: 6, 12 and 24 months
Best corrected visual acuity
The change in best corrected visual acuity (BCVA) through 6, 12 and 24 months
Time frame: 6, 12 and 24 months
Optic nerve head structural change
The change in optic nerve topography as measured by stereo photography through 6, 12, or 24 months 6. The change in visual field as measured by pattern standard deviation (PSD) through 6 months 7. The change in any of the above functional or structural measures at 12 or 24 months
Time frame: 6, 12 and 24 months
Visual field pattern standard deviation
The change in visual field as measured by pattern standard deviation (PSD) through 6, 12 or 24 months 7. The change in any of the above functional or structural measures at 12 or 24 months
Time frame: 6, 12 and 24 months
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