Latest1 information on COVID-19
©2022 Stanford Medicine
Trial ID: NCT04577300
A Randomized, Sham Controlled, Masked Phase II Study to Evaluate the Safety and Efficacy of Dual Intravitreal Implantation of NT-501 Encapsulated Cell Therapy for the Treatment of Glaucoma
1. Participant must be medically able to undergo the testing required in the schedule of
2. Participant's clinical diagnosis must be consistent with glaucoma characterized by the
following features: Mean deviation (MD) of -3 to -20 dB on Humphrey Visual Field 24-2
testing and two visual field tests of adequate quality with a maximum VFI variability
of ± 10%
3. Residual visual field preservation including best-corrected visual acuity (BCVA)
better than 20/200 in either eye.
4. Participant's eye pressure must be clinically stable, with IOP <21.
5. If a participant has two eyes meeting study criteria, the worse eye as determined by
visual field index (VFI) or patient preference, will be deemed includable. If both
eyes qualify and have the same VFI, a randomization procedure will assign one eye to
6. 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.
7. Females of childbearing potential must agree to use an effective form of birth
8. Participant must be determined by the presurgical anesthesia or medical team to be fit
for ophthalmic surgery for the NT-501 ECT implant insertion.
1. Participant is unable to comply with study procedures or followup visits.
2. Participant has other optic nerve or retinal degenerative disease causing vision loss,
irrespective of whether it is currently treated or untreated.
3. Participant is likely to be offered glaucoma surgery in the study eye within 6 months
4. Participant has cataract-associated vision loss to less than 20/40.
5. Participant has a history of ocular herpes zoster.
6. 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.
7. Participant has evidence of corneal opacification or lack of optical clarity.
8. Participant has uveitis or other ocular inflammatory disease.
9. Participant is receiving systemic steroids or other immunosuppressive medications.
10. Participant has diabetic macular edema and/or diabetic retinopathy.
11. Participant has myopic degeneration.
12. Participant is currently participating in or has within the last 3 months participated
in any other clinical trial of a drug by ocular (if in the study eye) or systemic
13. Participant is pregnant or lactating.
14. Participant is on chemotherapy.
15. Participant has a history of malignancy other than basal cell carcinoma, unless it was
treated successfully 2 years prior to inclusion in the trial.
16. Participant has, in the opinion of the investigator, any physical or mental condition
that would increase the risk of participation in the study or may interfere with the
study procedures, evaluations and outcome assessments.
17. Any intraocular surgery of the study eye within 12 weeks prior to the screening visit
18. History of use of drugs with known retinal toxicity, at retinotoxic doses.
19. Patient has a history of multiple sclerosis.
other: Sham comparator
School of Medicine
300 Pasteur Drive
Stanford, CA 94305