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Cell Therapy
NT-501 Cell Therapy for Glaucoma
Phase 2
Recruiting
Led By Jeffrey L Goldberg, MD, PhD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Residual visual field preservation including best-corrected visual acuity (BCVA) better than 20/200 in either eye
Residual visual field preservation including best-corrected visual acuity (BCVA) better than 20/200 in either eye.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial is testing a new treatment for glaucoma that involves injecting cells into the eye. The goal is to see if this treatment is safe and effective over two years.
Who is the study for?
This trial is for individuals with stable glaucoma, having an eye pressure (IOP) less than 21 and visual field loss within a specific range. Participants must have some remaining vision (20/200 or better), be able to undergo required tests, and agree to birth control if applicable. Exclusions include those with certain other eye conditions, recent participation in another drug trial, pregnancy, or systemic diseases affecting the eyes.Check my eligibility
What is being tested?
The study is testing NT-501 Encapsulated Cell Therapy (ECT), which aims to treat visual impairment due to glaucoma over a period of 24 months. Participants will receive either the NT-501 implants or a sham procedure as a comparison.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include typical risks associated with intravitreal injections such as eye inflammation, infection risk increase post-surgery, temporary vision changes, bleeding inside the eye and possible discomfort at the injection site.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can see better than 20/200 with correction in at least one eye.
Select...
My vision, with glasses or contacts, is better than 20/200 in at least one eye.
Select...
My glaucoma diagnosis shows a specific range of vision loss on a Humphrey Visual Field test.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Visual Field MD at 12 Months
Secondary outcome measures
Visual Field Index at 12 months
Visual Field PLR at 12 months
Side effects data
From 2019 Phase 2 trial • 22 Patients • NCT015306595%
Reversible Cardiac Vasospasm
5%
Secondary Surgical Intervention (excluding Posterior Capsulotomy)
5%
Pelvic fracture
5%
Pregnancy
5%
Total Eye Disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sham Surgery
Prior to Randomization
NT-501 Implant
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Single ImplantationExperimental Treatment1 Intervention
One NT-501 device will be implanted in the study eye.
Group II: Dual ImplantationExperimental Treatment1 Intervention
Two NT-501 devices will be implanted in the study eye.
Group III: Sham ImplantationPlacebo Group1 Intervention
No NT-501 devices will be implanted in the study eye.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NT-501
2017
Completed Phase 3
~390
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,320 Total Patients Enrolled
12 Trials studying Glaucoma
573 Patients Enrolled for Glaucoma
Jeffrey L Goldberg, MD, PhDPrincipal Investigator - Stanford University
Stanford Hospital, VA Palo Alto Healthcare System-Palo Alto Division
Stanford University School Of Medicine (Medical School)
University Miami/Jackson Mem Mc (Residency)
4 Previous Clinical Trials
200 Total Patients Enrolled
4 Trials studying Glaucoma
200 Patients Enrolled for Glaucoma
Media Library
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current participation rate for this trial?
"Affirmative. Clinicaltrials.gov displays that this clinical trial, which went live on May 15th 2021, is currently welcoming participants. It requires a total of 30 individuals to be selected from 1 site."
Answered by AI
Is enrollment to this trial still open?
"Based on data from clinicaltrials.gov, this medical experiment is currently recruiting test subjects. It was initially posted for review and consideration on May 15th 2021 and edited most recently November 15th 2022."
Answered by AI
Has the FDA accorded clearance to NT-501?
"Our internal assessment of NT-501's safety was 2 out of 3 due to the absence of efficacy data, though there is evidence backing its relative protection."
Answered by AI
Who else is applying?
What site did they apply to?
Byers Eye Institute at Stanford University
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
3+
What state do they live in?
Missouri
California
Why did patients apply to this trial?
indeed, I tried every eye drop, drug in my glaucoma treatment, but not working. My vision getting worse. I need a new treatment.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
safty, recovery, and can i join the trial?
PatientReceived 1 prior treatment
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