NT-501 ECT Implant for Glaucoma

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Stanford University

Must not be taking: Acyclovir, Immunosuppressives, Chemotherapy, others

Disqualifiers: Retinal disease, Diabetic retinopathy, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 24 months

54 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new eye implant called NT-501 for people with glaucoma. The implant releases medicine directly into the eye to help protect it from damage. It aims to help those who may not respond well to usual treatments. An earlier version of this implant has been used to help manage glaucoma in patients who did not benefit from other treatments.

Will I have to stop taking my current medications?

The trial requires that participants stop using acyclovir and related products before joining and throughout the study. If you are on systemic steroids or other immunosuppressive medications, you may not be eligible to participate.

Eligibility Criteria

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.

Inclusion Criteria

I have glaucoma with stable eye pressure and some vision left.

Participant must be medically able to undergo the testing required in the schedule of events (SOE).

Participant must understand and sign the informed consent.

Exclusion Criteria

I am currently taking steroids or other medications that weaken my immune system.

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.

I have a disease affecting my optic nerve or retina that causes vision loss.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the NT-501 ECT implant or sham surgery and are followed for safety and efficacy

24 months

Regular visits for safety assessments, including 1 day, 1 week, and periodic visits thereafter

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Open-label extension (optional)

Participants in the control arm may receive the NT-501 ECT implant and be followed for an additional 12 months

12 months

Treatment Details

Interventions

• NT-501 ECT implant

Trial Overview 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.

Participant Groups

Group I: NT-501 ECT Implant Experimental Treatment 1 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: Sham Placebo Group 1 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.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+