Trial Search Results

Study of NT-501 Encapsulated Cell Therapy for Glaucoma Neuroprotection and Vision Restoration

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Intervention(s):

  • Drug: NT-501 ECT implant
  • Other: Sham

Phase:

Phase 2

Eligibility


Inclusion Criteria:

Patients must meet all of the following criteria to join the study (all eligibility
criteria must be met at the screening and baseline visits unless otherwise noted):

   1. Participant must be medically able to undergo the testing required in the schedule of
   events (SOE).

   2. Participant's clinical diagnosis must be consistent with glaucoma 1. characterized by
   the following features:

   a) Clinical evidence of progressive retinal ganglion cell (RGC) dysfunction and
   degeneration using both visual field and at least one structural modality as
   established by: i. Glaucomatous visual field abnormality. ii. Mean deviation (MD) of
   -3 to -15 dB. iii. Minimum average retinal nerve fiber layer (RNFL) thickness of 60 μm
   and maximum average RNFL of 90 μm.

   b) Residual visual field preservation including best-corrected visual acuity (BCVA)
   better than 20/200 in both eyes.

   c) Two visual field tests of adequate quality with a maximum visual field index (VFI)
   variability of ± 10%.

   3. Participant's glaucoma must be clinically stable, with intraocular pressure (IOP) <
   21.

   4. 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.

   5. 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.

   6. Females of childbearing potential must agree to use an effective form of birth
   control.

   7. Participant must be determined by the presurgical anesthesia or medical team to be fit
   for ophthalmic surgery for the NT-501 ECT implant insertion.

Exclusion Criteria:

   1. Participant is unable to comply with study procedures or follow-up 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 has visual loss to less than 20/200 in non-study eye.

   4. Participant is likely to be offered glaucoma surgery within 6 months of screening.

   5. Participant has optic nerve atrophy beyond modest pallor.

   6. Participant has cataract-associated vision loss to less than 20/40.

   7. Participant has a history of ocular herpes zoster.

   8. 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.

   9. Participant has evidence of corneal opacification or lack of optical clarity.

10. Participant has uveitis or other ocular inflammatory disease.

11. Participant is receiving systemic steroids or other immunosuppressive medications.

12. Participant has diabetic macular edema and/or diabetic retinopathy.

13. Participant has myopic degeneration.

14. Participant is currently participating in or has within the last 3 months participated
   in any other clinical trial of a drug by ocular or systemic administration.

15. Participant is pregnant or lactating.

16. Participant is on chemotherapy.

17. Participant has a history of malignancy other than basal cell carcinoma, unless it was
   treated successfully 2 years prior to inclusion in the trial.

18. 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.

19. Participant has choroidal neovascularization secondary to age related macular
   degeneration or any other type of retinal degeneration that may interfere with the
   study procedures, evaluations and outcome assessments.

20. Any intraocular surgery of the study eye within 12 weeks prior to the screening visit

21. History of use of drugs with known retinal toxicity, at retinotoxic doses.

22. Participant has a history or current non-arteritic anterior ischemic neuropathy
   (NAION)

23. Patient has a history of multiple sclerosis.

24. Participant has glaucoma that is not considered open angle glaucoma, pseudoexfoliation
   glaucoma or pigmentary glaucoma..

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mariana Nunez
650-497-7846
Recruiting