Study of NT-501 Encapsulated Cell Therapy for Glaucoma Neuroprotection and Vision Restoration
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|ClinicalTrials.gov Identifier: NCT02862938|
Recruitment Status : Recruiting
First Posted : August 11, 2016
Last Update Posted : April 27, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma||Drug: NT-501 ECT implant Other: Sham||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized, Sham Controlled, Masked Phase II Study to Evaluate the Safety and Efficacy of Intravitreal Implantation of NT-501 Encapsulated Cell Therapy for the Treatment of Glaucoma|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||January 2020|
Experimental: NT-501 ECT Implant
On eligible participants that are randomized to this group, the NT-501 Investigational product will be implanted in the study eye, and participants will be followed for 24 months.
The investigational treatment, NT-501 ECT, provides intravitreal sustained release of soluble ciliary neurotrophic factor (CNTF) receptor after intraocular implantation.
Drug: NT-501 ECT implant
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 Comparator: Sham
To maintain masking, participants randomized to this group receive sham surgery and will be followed for 12 months. Following analysis of the 6 month data, if the open label extension (OLE) is not triggered, patients in the control group will continue on the original study schedule timeline trough month 24. If OLE is triggered participants will be offered the NT-501 ECT investigational product and will followed for additional 12 months.
- Visual Field [ Time Frame: 6 months ]
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:
- Visual Field Index (VFI)
- Mean Deviation (MD)
- Pointwise linear regression (PLR)
- Structural measure of retinal ganglion cell layer thickness [ Time Frame: 6, 12 and 24 months ]The change in ganglion cell layer thickness as measured by spectral domain optical coherence tomography (sdOCT).
- Structural measure of retinal nerve fiber layer thickness [ Time Frame: 6, 12 and 24 months ]The change in retinal nerve fiber layer thickness as measured by spectral domain optical coherence tomography (sdOCT).
- Contrast sensitivity [ Time Frame: 6, 12 and 24 months ]The change in contrast sensitivity through 6, 12 and 24 months
- Best corrected visual acuity [ Time Frame: 6, 12 and 24 months ]The change in best corrected visual acuity (BCVA) through 6, 12 and 24 months
- Optic nerve head structural change [ Time Frame: 6, 12 and 24 months ]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
- Visual field pattern standard deviation [ Time Frame: 6, 12 and 24 months ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02862938
|Contact: Mariana Nunezfirstname.lastname@example.org|
|United States, California|
|Byers Eye Institute at Stanford University||Recruiting|
|Palo Alto, California, United States, 94303|