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GlaucomaPhase 2NCT02862938

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

A Phase 2 study testing NT-501 ECT implant in people with Glaucoma, run by Stanford University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glaucoma
What is being tested?
NT-501 ECT implant
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
54 participants
Where
1 siteUnited States
Study dates
Jun 2016to 15 Aug 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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):
  • Participant must be medically able to undergo the testing required in the schedule of events (SOE).
  • Participant's clinical diagnosis must be consistent with glaucoma 1. characterized by the following features:
  • 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.
  • Residual visual field preservation including best-corrected visual acuity (BCVA) better than 20/200 in both eyes.
  • Two visual field tests of adequate quality with a maximum visual field index (VFI) variability of ± 10%.
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  • Participant's glaucoma must be clinically stable, with intraocular pressure (IOP) < 21.
  • 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.
  • 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.
  • Females of childbearing potential must agree to use an effective form of birth control.
  • Participant must be determined by the presurgical anesthesia or medical team to be fit for ophthalmic surgery for the NT-501 ECT implant insertion.

Who cannot join

  • Participant is unable to comply with study procedures or follow-up visits.
  • Participant has other optic nerve or retinal degenerative disease causing vision loss, irrespective of whether it is currently treated or untreated.
  • Participant has visual loss to less than 20/200 in non-study eye.
  • Participant is likely to be offered glaucoma surgery within 6 months of screening.
  • Participant has optic nerve atrophy beyond modest pallor.
  • Participant has cataract-associated vision loss to less than 20/40.
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  • Participant has a history of ocular herpes zoster.
  • 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.
  • Participant has evidence of corneal opacification or lack of optical clarity.
  • Participant has uveitis or other ocular inflammatory disease.
  • Participant is receiving systemic steroids or other immunosuppressive medications.
  • Participant has diabetic macular edema and/or diabetic retinopathy.
  • Participant has myopic degeneration.
  • 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.
  • Participant is pregnant or lactating.
  • Participant is on chemotherapy.
  • Participant has a history of malignancy other than basal cell carcinoma, unless it was treated successfully 2 years prior to inclusion in the trial.
  • 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.
  • 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.
  • Any intraocular surgery of the study eye within 12 weeks prior to the screening visit
  • History of use of drugs with known retinal toxicity, at retinotoxic doses.
  • Participant has a history or current non-arteritic anterior ischemic neuropathy (NAION)
  • Patient has a history of multiple sclerosis.
  • Participant has glaucoma that is not considered open angle glaucoma, pseudoexfoliation glaucoma or pigmentary glaucoma..

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Byers Eye Institute at Stanford University

    Palo Alto, California, 94303

Other trials in United States

About this study

Official title: A Randomized, Sham Controlled, Masked Phase II Study to Evaluate the Safety and Efficacy of Intravitreal Implantation of NT-501 Encapsulated Cell Therapy for the Treatment of Glaucoma

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.

Conditions
Glaucoma
Being tested
NT-501 ECT implant, Sham
Medical subject headings
Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NT-501 ECT implantDrug

    NT-501 ECT implant will be placed into the vitreous and out of the visual axis of the study eye. The surgical procedure involves making a small incision through the sclera (white part of the eye), inserting the implant and securing it with a suture.

  • ShamOther

    Sham surgery

Study groups in NCT02862938
Study groupRoleWhat they receive
NT-501 ECT ImplantExperimentalOn eligible participants that are randomized to this group, the NT-501 Investigational product will be implanted in the study eye, and participants will be followed for 24 months. The investigational treatment, NT-501 ECT, provides intravitreal sustained release of soluble ciliary neurotrophic factor (CNTF) receptor after intraocular implantation.
Receives: Drug: NT-501 ECT implant
ShamSham comparatorTo maintain masking, participants randomized to this group receive sham surgery and will be followed for 12 months. Following analysis of the 6 month data, if the open label extension (OLE) is not triggered, patients in the control group will continue on the original study schedule timeline trough month 24. If OLE is triggered participants will be offered the NT-501 ECT investigational product and will followed for additional 12 months.
Receives: Other: Sham

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual Field

    Determine the efficacy of NT-501 ECT implant in patients with glaucoma as measured by change in visual field through 6 months as assessed by any one of the following three indices:

    1. Visual Field Index (VFI)
    2. Mean Deviation (MD)
    3. Pointwise linear regression (PLR)

    Measured: 6 months

Secondary outcomes (6)

  1. Structural measure of retinal ganglion cell layer thickness

    The change in ganglion cell layer thickness as measured by spectral domain optical coherence tomography (sdOCT).

    Measured: 6, 12 and 24 months

  2. Structural measure of retinal nerve fiber layer thickness

    The change in retinal nerve fiber layer thickness as measured by spectral domain optical coherence tomography (sdOCT).

    Measured: 6, 12 and 24 months

  3. Contrast sensitivity

    The change in contrast sensitivity through 6, 12 and 24 months

    Measured: 6, 12 and 24 months

  4. Best corrected visual acuity

    The change in best corrected visual acuity (BCVA) through 6, 12 and 24 months

    Measured: 6, 12 and 24 months

  5. Optic nerve head structural change

    The change in optic nerve topography as measured by stereo photography through 6, 12, or 24 months 6. The change in visual field as measured by pattern standard deviation (PSD) through 6 months 7. The change in any of the above functional or structural measures at 12 or 24 months

    Measured: 6, 12 and 24 months

  6. Visual field pattern standard deviation

    The change in visual field as measured by pattern standard deviation (PSD) through 6, 12 or 24 months 7. The change in any of the above functional or structural measures at 12 or 24 months

    Measured: 6, 12 and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2016 (estimated)
  2. Study startJun 2016
  3. Primary completion15 Aug 2025
  4. Study completion15 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02862938
Sponsor's protocol ID
37202
Status last verified
Nov 2025
First submitted
1 Aug 2016
Last updated
4 Nov 2025
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NT-501 ECT implant in people with Glaucoma, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Field (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02862938.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2025.

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