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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.
Must not have
Participant is unable to comply with study procedures or followup visits
Participant is on chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months

Summary

This trial tests tiny devices that release a protective protein into the eyes of patients with glaucoma-related vision problems. The protein helps protect nerve cells, potentially preventing further vision loss and improving sight.

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.
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.
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 below
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I can see better than 20/200 with correction in at least one eye.
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My vision, with glasses or contacts, is better than 20/200 in at least one eye.
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My glaucoma diagnosis shows a specific range of vision loss on a Humphrey Visual Field test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I can follow the study's procedures and attend all visits.
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I am currently undergoing chemotherapy.
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My vision is worse than 20/40 due to cataracts.
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I have a vision loss condition due to optic nerve or retinal disease.
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I will stop using acyclovir or similar drugs before and during the study.
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My eyes have cloudy or unclear corneas.
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I have inflammation in my eye.
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I am likely to undergo glaucoma surgery in the next 6 months.
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I am currently taking steroids or other medications that weaken my immune system.
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I have diabetic eye problems.
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I haven't had eye surgery on the study eye in the last 12 weeks.
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I have used medication known to harm the retina.
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I have myopic degeneration.
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I have been diagnosed with multiple sclerosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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 MD at 12 Months
Secondary study objectives
Visual Field Index at 12 months
Visual Field PLR at 12 months

Side effects data

From 2022 Phase 3 trial • 120 Patients • NCT03316300
21%
Conjunctival haemmorhage
12%
Foreign body sensation in eyes
11%
Dry eye
9%
Eye pain
9%
Hypertension
7%
COVID-19
5%
Eye pruritus
5%
Conjunctival hyperaemia
5%
Headache
5%
Influenza
5%
Vision blurred
5%
Visual impairment
5%
Rash
4%
Fall
4%
Arthritis
4%
Arrhythmia
4%
Conjunctival oedema
4%
Choroidal neovascularisation
4%
Herpes zoster
4%
Tinnitus
4%
Blepharospasm
4%
Osteoarthritis
4%
Upper respiratory tract infection
4%
Tooth infection
2%
Cataract nuclear
2%
Eye naevus
2%
Essential hypertension
2%
Suture related complication
2%
Meibomian gland dysfunction
2%
Retinal artery embolism
2%
Food poisoning
2%
Gastroesophageal reflux disease
2%
Sinus headache
2%
Eccentric fixation
2%
Diverticulum
2%
Conjunctivitis viral
2%
Glucose tolerance impaired
2%
Cardiac failure congestive
2%
Coronary Artery Disease
2%
Raynaud's phenomenon
2%
Swelling face
2%
Drug hypersensitivity
2%
Skin laceration
2%
Wrist fracture
2%
Acute myocardial infarction
2%
Angina pectoris
2%
Coronary artery disease
2%
Anaemia
2%
Retinal haemorrhage
2%
Infected bite
2%
Back injury
2%
Joint dislocation
2%
Tachycardia
2%
Large intestine polyp
2%
Rotator cuff syndrome
2%
Hypokalaemia
2%
Seasonal allergy
2%
Cellulitis
2%
Blood pressure increased
2%
Iridocyclitis
2%
Arthralgia
2%
Osteonecrosis
2%
Osteopenia
2%
Benign prostatic hyperplasia
2%
Type V hyperlipidaemia
2%
Delayed dark adaptation
2%
Urinary tract infection
2%
Visual acuity reduced
2%
Biopsy prostate abnormal
2%
Vitamin D deficiency
2%
Photophobia
2%
Balance disorder
2%
Carotid artery occlusion
2%
Metabolic encephalopathy
2%
Cataract
2%
Diplopia
2%
Basal Cell Carcinoma
2%
Myocardial Infarcation
2%
Colorectal adenoma
2%
Comminuted fracture
2%
Pancreatic cyst
2%
Sinusitis
2%
Appendicitis
2%
Anxiety
2%
Intraocular pressure increased
2%
Foot fracture
2%
Radiculopathy
2%
Ocular discomfort
2%
Acute kidney injury
2%
Intervertebral disc degeneration
2%
Respiratory tract infection
2%
Soft Tissue Injury
2%
Sepsis
2%
Erectile dysfunction
2%
Cough
2%
Obstructive sleep apnoea syndrome
2%
Heart rate irregular
2%
Tooth fracture
2%
Soft tissue injury
2%
Tendon injury
2%
Constipation
2%
Gastritis
2%
Cholelithiasis
2%
Blister
2%
Micturition urgency
2%
Muscle spasms
2%
Nasopharyngitis
2%
Gastroenteritis
2%
Impetigo
2%
Subcutaneous abscess
2%
Suspected COVID-19
2%
Vaginal infection
2%
Hypercholesterolaemia
2%
Hyperglycaemia
2%
Hypernatraemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sham
NT-501

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
~330

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,489 Previous Clinical Trials
17,516,964 Total Patients Enrolled
13 Trials studying Glaucoma
623 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
220 Total Patients Enrolled
4 Trials studying Glaucoma
220 Patients Enrolled for Glaucoma

Media Library

NT-501 (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04577300 — Phase 2
~4 spots leftby Aug 2025
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