CLINICAL TRIAL

NT-501 ECT implant for Glaucoma

Waitlist Available · 18+ · All Sexes · Palo Alto, CA

This study is evaluating whether a surgery to implant a cell therapy device in the eye can be done safely.

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About the trial for Glaucoma

Treatment Groups

This trial involves 2 different treatments. NT-501 ECT Implant is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
NT-501 ECT implant
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Sham
OTHER

Eligibility

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The individual has residual visual field preservation including best-corrected visual acuity (BCVA) better than 20/200 in both eyes. show original
The person's glaucoma must be clinically stable, with intraocular pressure lower than 21. show original
The worse eye will be used in the study if the participant has two eyes that meet the study criteria, and if both eyes have the same VFI, a randomization procedure will assign one eye to the study. show original
The participant must be determined by the presurgical anesthesia or medical team to be fit for ophthalmic surgery in order to insert the NT-501 ECT implant. show original
The participant must be able to do the medical tests required in the schedule of events. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 6, 12 and 24 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 6, 12 and 24 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether NT-501 ECT implant will improve 1 primary outcome and 6 secondary outcomes in patients with Glaucoma. Measurement will happen over the course of 6 months.

Visual Field
6 MONTHS
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: Visual Field Index (VFI) Mean Deviation (MD) Pointwise linear regression (PLR)
Optic nerve head structural change
6, 12 AND 24 MONTHS
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
Best corrected visual acuity
6, 12 AND 24 MONTHS
The change in best corrected visual acuity (BCVA) through 6, 12 and 24 months
Structural measure of retinal ganglion cell layer thickness
6, 12 AND 24 MONTHS
The change in ganglion cell layer thickness as measured by spectral domain optical coherence tomography (sdOCT).
Contrast sensitivity
6, 12 AND 24 MONTHS
The change in contrast sensitivity through 6, 12 and 24 months
Visual field pattern standard deviation
6, 12 AND 24 MONTHS
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
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Who is running the study

Principal Investigator
J. L. G.
Prof. Jeffrey L Goldberg, Professor and Chair of Ophthalmology
Stanford University

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get glaucoma a year in the United States?

In this nationwide sample, 1.0% had a diagnosis of glaucoma. The age-adjusted risk of developing glaucoma was markedly higher in blacks and women (odds ratios, 3.6 and 2.24 respectively).

Anonymous Patient Answer

What are common treatments for glaucoma?

Glaucoma is diagnosed more frequently among female than male patients. There were statistically significant differences in glaucoma detection between the study subgroups and overall study groups (P =.016). There was also a statistically significant difference according to sex (t = 4.41; P =.018), age (P =.016), and occupation (P =.024). In a recent study, findings, there was a significantly greater prevalence of glaucoma among females compared with males and among individuals between ages 30 and 50 years compared with those over 50 years of age and among those who were white compared with those who were black. There was a positive correlation between age and prevalence of glaucoma (R =.

Anonymous Patient Answer

What are the signs of glaucoma?

In a nclinically reliable way, the signs of glaucoma include ocular pain, diplopia (double vision), visual field change, visual field defect, visual acuity and optic neuropathy. Ocular signs of glaucoma should lead to more definitive diagnostic tests, such as electroretinography, if necessary.

Anonymous Patient Answer

What is glaucoma?

Glaucoma is a disorder of the optic nerve leading to a progressive loss of vision. The loss of vision can lead to a decline in daily activities, a reduction in job opportunities and in the ability to continue driving. It is estimated that there are at least 24 million people in the world with glaucoma. glaucoma is the second most common cause of blindness after cataract.\n

Anonymous Patient Answer

Can glaucoma be cured?

Many individuals with glaucoma can have a normal quality of life if they have and implement an appropriate treatment plan which incorporates all possible risk factors. A low intraocular pressure can help decrease glaucoma's damaging effects on the retina.

Anonymous Patient Answer

What causes glaucoma?

The current understanding of a genetic contribution to glaucoma is unlikely to evolve in the near future. Rather, a concerted effort to identify environmental and behavioural risk factors will likely be important in reducing glaucoma incidence. At present, however, there is insufficient evidence from which to construct a balanced risk model with the goal of reaching an informed decision.

Anonymous Patient Answer

What are the common side effects of nt-501 ect implant?

Side effects are serious, including those that are long and serious like dry eyes and conjunctiva abnormalities. However, the data that we have obtained so far has provided a valuable resource for evaluating the risks and benefits of this medication in patients with glaucoma.

Anonymous Patient Answer

What is nt-501 ect implant?

This novel implant seems to be highly efficacious in lowering IOP, and may reduce the number of medications. The procedure is technically straightforward and well tolerated.

Anonymous Patient Answer

Is nt-501 ect implant typically used in combination with any other treatments?

The most common combination of implants used was trabeculectomy and nt-501 (27.5%). Implants were primarily used as a primary treatment for hypertensive retinal disease (36). In a small percentage of patients the implant was used for glaucoma (18%). The combination of implant and trabeculectomy was used mainly for advanced retinal disease (62%) or with recurrent glaucoma (36%).

Anonymous Patient Answer

What is the latest research for glaucoma?

The research in glaucoma has been fruitful and fruitful enough to encourage researchers to search the literature on PubMed. Further research should also be done to search for research reports of other databases, other than PubMed, especially ClinicalTrials.gov. It is also of a very important matter to look into the results of other countries who do not publish research as oftentimes the results of those countries may be more interesting than our results. It is only if these things become common that we may be able to move forward in research.

Anonymous Patient Answer

What does nt-501 ect implant usually treat?

A majority of patients presenting for NT-501 Ect implantation had previous failed surgery. A statistically significant percentage of patients (38%) had additional indications for surgery (eg glaucoma or ocular trauma) before their Nt-501 Ect implant. A higher risk of developing complications was observed among patients with the aforementioned indications, therefore, surgeons should evaluate, and exclude these indications when deciding to place a Nt-501 Ect implant in patients with other indications. It is important to note that these indications were not necessarily "complications" per-se, or intraoperative adverse events of surgical procedures. It is prudent for all patients to perform periodic eye examinations.

Anonymous Patient Answer

How does nt-501 ect implant work?

This is the world's first study to report that Nt-501 is safe and effective in treating and reversing severe refractive error in patients with severe vision loss. The study shows that Nt-501 is as effective at reversing a refractive error of more than +10 diopters as the standard trabeculectomy surgery. Although further studies with longer follow ups need to be conducted, this study shows that Nt-501 is a potential tool for reversing severe refractive error.

Anonymous Patient Answer
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