GlaucomaPhase 2NCT04577300
Dual Intravitreal Implantation of NT-501 Encapsulated Cell Therapy for Glaucoma
A Phase 2 study testing NT-501 in people with Glaucoma, run by Stanford University at 1 site in United States.
Trial 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 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2021to 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
- 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 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%
- Residual visual field preservation including best-corrected visual acuity (BCVA) better than 20/200 in either eye.
- Participant's eye pressure must be clinically stable, with IOP <21.
- 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.
- 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 followup visits.
- Participant has other optic nerve or retinal degenerative disease causing vision loss, irrespective of whether it is currently treated or untreated.
- Participant is likely to be offered glaucoma surgery in the study eye within 6 months of screening.
- Participant has cataract-associated vision loss to less than 20/40.
- 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.
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- 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 (if in the study eye) 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.
- 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.
- Patient has a history of multiple sclerosis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Byers Eye Institute at Stanford University
Palo Alto, California, 94303
About this study
Official title: A Randomized, Sham Controlled, Masked Phase II Study to Evaluate the Safety and Efficacy of Dual Intravitreal Implantation of NT-501 Encapsulated Cell Therapy for the Treatment of Glaucoma
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.
- Conditions
- Glaucoma
- Being tested
- NT-501, Sham comparator
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NT-501Drug
Implant of Neurotech NT-501 device(s)
Sham comparatorOther
Sham implantation
| Study group | Role | What they receive |
|---|---|---|
| Dual Implantation | Experimental | Two NT-501 devices will be implanted in the study eye. Receives: Drug: NT-501 |
| Single Implantation | Experimental | One NT-501 device will be implanted in the study eye. Receives: Drug: NT-501 |
| Sham Implantation | Sham comparator | No NT-501 devices will be implanted in the study eye. Receives: Other: Sham comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Field MD at 12 Months
Change from baseline in visual field through 12 months as assessed by Mean Deviation (MD).
Measured: 12 months
Secondary outcomes (2)
Visual Field Index at 12 months
Change from baseline in visual field through 12 months as assessed by Visual Field Index (VFI).
Measured: 12 months
Visual Field PLR at 12 months
Change from baseline in visual field pointwise linear regression (PLR) through 12 months.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start15 May 2021
- Primary completion15 Aug 2025
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey L Goldberg, Stanford University
- Investigators
- Jeffrey L Goldberg, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04577300
- Sponsor's protocol ID
- 56950
- Status last verified
- Nov 2025
- First submitted
- 25 Sep 2020
- Last updated
- 4 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Sham Controlled, Masked Phase II Study to Evaluate the Safety and Efficacy of Dual Intravitreal Implantation of NT-501 Encapsulated Cell Therapy for the Treatment of Glaucoma
- ClinicalTrials.gov ID
- NCT04577300
- Acronym / sponsor ID
- 56950
- Conditions
- Glaucoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 6 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the safety and efficacy over 24 months of dual NT-501 CNTF encapsulated cell therapy (ECT) on visual impairment related to glaucoma.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dual Implantation | Experimental | Drug: NT-501Two NT-501 devices will be implanted in the study eye. |
| Single Implantation | Experimental | Drug: NT-501One NT-501 device will be implanted in the study eye. |
| Sham Implantation | Sham comparator | Other: Sham comparatorNo NT-501 devices will be implanted in the study eye. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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 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%
- Residual visual field preservation including best-corrected visual acuity (BCVA) better than 20/200 in either eye.
- Participant's eye pressure must be clinically stable, with IOP <21.
- 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.
Key exclusion criteria (19 listed)
- Participant is unable to comply with study procedures or followup visits.
- Participant has other optic nerve or retinal degenerative disease causing vision loss, irrespective of whether it is currently treated or untreated.
- Participant is likely to be offered glaucoma surgery in the study eye within 6 months of screening.
- Participant has cataract-associated vision loss to less than 20/40.
- Participant has a history of ocular herpes zoster.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NT-501Implant of Neurotech NT-501 device(s) | Drug | Dual Implantation, Single Implantation |
| Sham comparatorSham implantation | Other | Sham Implantation |
Primary outcome
Visual Field MD at 12 Months
Time frame: 12 months
Change from baseline in visual field through 12 months as assessed by Mean Deviation (MD).
2 secondary outcomes
Visual Field Index at 12 months
Time frame: 12 months
Visual Field PLR at 12 months
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey L Goldberg, MD, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NT-501 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 8 inclusion and 19 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 MD at 12 Months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.