What side effects are associated with this type of intervention?

Common treatments for glaucoma include topical medications, laser therapy, and surgical interventions. Topical medications, such as prostaglandin analogs, beta-blockers, and alpha agonists, can cause side effects like eye redness, irritation, and systemic effects such as bradycardia or respiratory issues. Laser therapies, like trabeculoplasty, may lead to transient increases in intraocular pressure and inflammation. Surgical options, including trabeculectomy and shunt implantation, carry risks of infection, bleeding, and vision loss. Encapsulated cell therapies, like NT-501 ECT, aim to provide long-term delivery of therapeutic agents with potentially fewer side effects, but their safety profile is still under investigation. Generally, intraocular implants can cause inflammation, infection, and mechanical complications.

What prior FDA approvals exist?

The NT-501 Encapsulated Cell Therapy (ECT) for glaucoma involves encapsulated cell therapy to deliver therapeutic agents. While specific FDA approvals for encapsulated cell therapies for glaucoma are not detailed, several other treatments have been approved for managing glaucoma. These include prostaglandin analogs (e.g., latanoprost, bimatoprost), beta-blockers (e.g., timolol), alpha agonists (e.g., brimonidine), carbonic anhydrase inhibitors (e.g., dorzolamide), and Rho kinase inhibitors (e.g., netarsudil). These treatments primarily aim to reduce intraocular pressure, a key factor in glaucoma management.

What other types of research exist?

Promising novel alternatives to NT-501 Encapsulated Cell Therapy for glaucoma patients include: 1) Gene therapy approaches, such as those targeting neuroprotection and regeneration of retinal ganglion cells. 2) Stem cell therapies, which aim to replace damaged cells and restore vision. 3) Sustained-release drug delivery systems, like bimatoprost implants, which provide long-term IOP reduction. 4) Minimally invasive glaucoma surgeries (MIGS), which improve aqueous humor outflow and reduce IOP with fewer complications compared to traditional surgeries.

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Cell Therapy

NT-501 ECT Implant for Glaucoma

Q: What is the mechanism of action of this treatment?

Common treatments for glaucoma primarily aim to reduce intraocular pressure (IOP) to prevent optic nerve damage. These treatments include medications like prostaglandin analogs, beta-blockers, alpha agonists, and carbonic anhydrase inhibitors, which either decrease aqueous humor production or increase its outflow. Surgical options, such as trabeculectomy and laser therapy, also aim to enhance fluid drainage. The NT-501 Encapsulated Cell Therapy (ECT) represents a novel approach by delivering therapeutic agents directly to the eye, potentially offering neuroprotection and vision restoration. This is significant for glaucoma patients as it may provide sustained treatment effects and reduce the need for frequent medication administration, thereby improving adherence and outcomes.

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

Must not have

Participant is receiving systemic steroids or other immunosuppressive medications.

Participant has other optic nerve or retinal degenerative disease causing vision loss.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6, 12 and 24 months

Summary

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.

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.

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.

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 below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have significant damage to my optic nerve.

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My vision is worse than 20/40 due to cataracts.

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I have used medication known to harm the retina.

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I have been diagnosed with multiple sclerosis.

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I have glaucoma, but it's not open angle, pseudoexfoliation, or pigmentary type.

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I have myopic degeneration.

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I have abnormal blood vessels in my eye due to aging or other retinal issues.

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I need to take acyclovir or similar drugs during the study.

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I have inflammation in my eye.

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I can follow the study's procedures and attend all visits.

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I have diabetic eye problems.

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I have a history of or currently have a specific type of eye stroke.

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My eyes have cloudy or unclear corneas.

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I am currently undergoing chemotherapy.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6, 12 and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Visual Field

Secondary study objectives

Best corrected visual acuity

Contrast sensitivity

Optic nerve head structural change

+3 more

Trial 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.

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for glaucoma primarily aim to reduce intraocular pressure (IOP) to prevent optic nerve damage. These treatments include medications like prostaglandin analogs, beta-blockers, alpha agonists, and carbonic anhydrase inhibitors, which either decrease aqueous humor production or increase its outflow. Surgical options, such as trabeculectomy and laser therapy, also aim to enhance fluid drainage. The NT-501 Encapsulated Cell Therapy (ECT) represents a novel approach by delivering therapeutic agents directly to the eye, potentially offering neuroprotection and vision restoration. This is significant for glaucoma patients as it may provide sustained treatment effects and reduce the need for frequent medication administration, thereby improving adherence and outcomes.

Intravitreal bromfenac liposomal suspension (100 μg / 0.1 ml). A safety study in rabbit eyes.Epigallocatechin Gallate-Loaded Gelatin-g-Poly(N-Isopropylacrylamide) as a New Ophthalmic Pharmaceutical Formulation for Topical Use in the Treatment of Dry Eye Syndrome.Topical Drug Delivery to the Posterior Segment of the Eye: Addressing the Challenge of Preclinical to Clinical Translation.