Could an eye implant stop glaucoma from stealing your sight?
NCT ID NCT04577300
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This phase 2 trial tests whether an implant placed in the eye can slow vision loss in people with glaucoma. The implant releases a protein that may protect nerve cells. Thirty participants will receive either the real implant or a sham procedure and be followed for two years.
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 (releases ciliary neurotrophic factor)
- What this could lead to
- If it works, this could point toward a new way to slow vision loss in glaucoma by protecting nerve cells in the eye.
- What could go wrong
- This is a small, early-phase trial with only 30 people, so results may not apply to everyone. The implant requires surgery and may cause side effects like infection or inflammation.
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
-
About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
May 2021
- 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 Hide 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: 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: 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.
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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.
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