Study of NT-501 Encapsulated Cell Therapy for Glaucoma Neuroprotection and Vision Restoration (NCT02862938) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study of NT-501 Encapsulated Cell Therapy for Glaucoma Neuroprotection and Vision Restoration
United States54 participantsStarted 2016-06
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Participant must be medically able to undergo the testing required in the schedule of events (SOE).
✓. Participant's clinical diagnosis must be consistent with glaucoma 1. characterized by the following features:
✓. Participant's glaucoma must be clinically stable, with intraocular pressure (IOP) \< 21.
✓. If a participant has two eyes meeting study criteria, only the worse eye as determined by visual field index (VFI) will be deemed includable. If both eyes qualify and have the same VFI, a randomization procedure will assign one eye to the study.
✓. Participant must understand and sign the informed consent. If the participant's vision is impaired to the point where he/she cannot read the informed consent document, the document will be read to the participant in its entirety.
✓. Females of childbearing potential must agree to use an effective form of birth control.
✓. Participant must be determined by the presurgical anesthesia or medical team to be fit for ophthalmic surgery for the NT-501 ECT implant insertion.
. Participant is unable to comply with study procedures or follow-up visits.
✕. Participant has other optic nerve or retinal degenerative disease causing vision loss, irrespective of whether it is currently treated or untreated.
✕. Participant has visual loss to less than 20/200 in non-study eye.
✕. Participant is likely to be offered glaucoma surgery within 6 months of screening.
✕. Participant has optic nerve atrophy beyond modest pallor.
✕. Participant has cataract-associated vision loss to less than 20/40.
✕. Participant has a history of ocular herpes zoster.
✕. Participant has a requirement of acyclovir and/or related products during study duration. To be eligible for this study, the participant must discontinue use of these products prior to enrollment and must not continue with the products until after they have completed the study.