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Could a tiny eye implant save your sight from glaucoma?

NCT ID NCT02862938

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests a small implant (NT-501) placed inside the eye to protect nerve cells and slow vision loss in people with glaucoma. 54 participants will either get the implant or a sham surgery, and their vision will be tracked for 2 years. The implant releases a protein that may keep retinal cells alive longer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NT-501 encapsulated cell therapy implant
What this could lead to
If successful, this implant could slow or stop vision loss in glaucoma patients by continuously delivering protective proteins to the eye.
What could go wrong
This is a small, early-phase trial (54 people) with a sham surgery control. The implant requires eye surgery, which carries risks like infection or implant issues. Results may not confirm benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

54 people

The number who actually took part.

Start date

Jun 2016

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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..

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Byers Eye Institute at Stanford University

    Palo Alto, California, 94303, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.