Your session is about to expire
← Back to Search
Cell Therapy
NT-501 ECT Implant for Glaucoma
Phase 2
Waitlist Available
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant's clinical diagnosis must be consistent with glaucoma characterized by specific features including progressive retinal ganglion cell (RGC) dysfunction and degeneration, residual visual field preservation, and clinically stable intraocular pressure (IOP) < 21.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6, 12 and 24 months
Awards & highlights
Study Summary
This trial is testing a new eye surgery for people with glaucoma. The surgery will either be the new treatment or a fake surgery, and no one will know which they got. There will be follow-up appointments to check safety and to see if the new treatment works better than the fake surgery.
Who is the study for?
This trial is for people with glaucoma who have specific visual field and retinal nerve fiber layer measurements, stable intraocular pressure, and good enough vision to participate. They must be able to undergo required tests, agree to birth control if applicable, and be fit for eye surgery. Exclusions include certain drug histories, other health conditions that could interfere with the study or pose risks.Check my eligibility
What is being tested?
The trial is testing NT-501 encapsulated cell therapy (ECT) implant against a sham surgery in patients with glaucoma. Participants are randomly assigned to either receive the real implant or a fake procedure without explant needed. Safety checks follow one day and one week after surgery then periodically over two years.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include typical surgical risks like infection or inflammation at the implant site, reaction to anesthesia, changes in vision or eye pressure due to the implant itself.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have glaucoma with stable eye pressure and some vision left.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6, 12 and 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6, 12 and 24 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
Secondary outcome measures
Best corrected visual acuity
Contrast sensitivity
Optic nerve head structural change
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: NT-501 ECT ImplantExperimental Treatment1 Intervention
On 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.
Group II: ShamPlacebo Group1 Intervention
To 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.
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,386 Previous Clinical Trials
17,333,954 Total Patients Enrolled
12 Trials studying Glaucoma
549 Patients Enrolled for Glaucoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking steroids or other medications that weaken my immune system.I have glaucoma with stable eye pressure and some vision left.I have a disease affecting my optic nerve or retina that causes vision loss.I have significant damage to my optic nerve.My vision is worse than 20/40 due to cataracts.I have used medication known to harm the retina.I have been diagnosed with multiple sclerosis.I have glaucoma, but it's not open angle, pseudoexfoliation, or pigmentary type.I have myopic degeneration.I had cancer other than skin cancer, but it was successfully treated over 2 years ago.I have abnormal blood vessels in my eye due to aging or other retinal issues.I need to take acyclovir or similar drugs during the study.I have inflammation in my eye.I am considered fit for eye surgery to insert the NT-501 ECT implant.I can follow the study's procedures and attend all visits.I have diabetic eye problems.I have a history of or currently have a specific type of eye stroke.My eyes have cloudy or unclear corneas.I am currently undergoing chemotherapy.I have not had eye surgery on the study eye in the last 3 months.I am likely to undergo glaucoma surgery within the next 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: NT-501 ECT Implant
- Group 2: Sham
Awards:
This trial has 0 awards, including: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.
Is access to this research still available for volunteers?
"As per clinicaltrials.gov, this investigation is not currently recruiting individuals into its study cohort. It was initially posted in June 2016 and most recently updated on November 15th 2022; although it is presently inactive, there are 206 other trials that require participants at the time of writing."
Answered by AI
Has the NT-501 ECT implant been certified by the FDA?
"Our team at Power judges the NT-501 ECT implant to be a 2 on the safety scale because of its Phase 2 nature; meaning there is some proof of security but none that it works."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger