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Active, not recruitingNCT04577300Updated Nov 4, 2025

Dual Intravitreal Implantation of NT-501 Encapsulated Cell Therapy for Glaucoma

A Phase 2 interventional study of NT-501 and Sham comparator in Glaucoma, sponsored by Stanford University. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-04.

Sponsored by Stanford University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

To determine the safety and efficacy over 24 months of dual NT-501 CNTF encapsulated cell therapy (ECT) on visual impairment related to glaucoma.

Read the detailed description

A randomized, sham controlled, masked trial of up to 30 eyes will be recruited into the study. Participants with a qualifying study eye will be randomized after screening and baseline evaluations to receive 2 NT-501 ECT implants in the study eye (20 eyes), 1 NT-501 ECT implant (5 eyes) or a sham surgery (control arm; 5 eyes). 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. Patients in the control arm may be offered 2 NT-501 ECT implants after the 12-month post-operative follow-up visit.

02

Conditions studied

  • Glaucoma

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03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's planned enrollment of 30 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  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 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 the study.
  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 control.
  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.

Exclusion criteria

Exclusion Criteria:

  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 of screening.
  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 administration.
  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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Dual Implantation

    Two NT-501 devices will be implanted in the study eye.

    Drug: NT-501

  • Experimental
    Single Implantation

    One NT-501 device will be implanted in the study eye.

    Drug: NT-501

  • Sham comparator
    Sham Implantation

    No NT-501 devices will be implanted in the study eye.

    Other: Sham comparator

Interventions

  • DrugNT-501

    Implant of Neurotech NT-501 device(s)

  • OtherSham comparator

    Sham implantation

06

What researchers measure

Primary outcomes

  1. Visual Field MD at 12 Months

    Change from baseline in visual field through 12 months as assessed by Mean Deviation (MD).

    Time frame: 12 months

Secondary outcomes

  1. Visual Field Index at 12 months

    Change from baseline in visual field through 12 months as assessed by Visual Field Index (VFI).

    Time frame: 12 months

  2. Visual Field PLR at 12 months

    Change from baseline in visual field pointwise linear regression (PLR) through 12 months.

    Time frame: 12 months

07

Study locations

1 site
  • Byers Eye Institute at Stanford University
    Palo Alto, California 94303, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04577300
Lead sponsor
Stanford University
Responsible party
Jeffrey L Goldberg (Professor, Stanford University) — Principal investigator
First posted
Oct 6, 2020
Start date
May 15, 2021
Primary completion
Aug 15, 2025
Completion
Aug 15, 2026 (estimated)
Last update
Nov 4, 2025

Study contacts

Jeffrey L Goldberg, MD, PhD
principal investigator · Stanford University

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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