Dual Intravitreal Implantation of NT-501 Encapsulated Cell Therapy for Glaucoma

NCT04577300 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: 56950
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the safety and efficacy over 24 months of dual NT-501 CNTF encapsulated cell therapy (ECT) on visual impairment related to glaucoma.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• Visual Field MD at 12 Months

  Change from baseline in visual field through 12 months as assessed by Mean Deviation (MD).

  12 months

Secondary Outcomes (2)

• Visual Field Index at 12 months

  12 months

• Visual Field PLR at 12 months

  12 months

Study Arms (3)

Dual Implantation

EXPERIMENTAL

Two NT-501 devices will be implanted in the study eye.

Drug: NT-501

Single Implantation

EXPERIMENTAL

One NT-501 device will be implanted in the study eye.

Drug: NT-501

Sham Implantation

SHAM COMPARATOR

No NT-501 devices will be implanted in the study eye.

Other: Sham comparator

Interventions

NT-501 DRUG

Implant of Neurotech NT-501 device(s)

Dual Implantation; Single Implantation

Sham comparator OTHER

Sham implantation

Sham Implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be medically able to undergo the testing required in the schedule of events (SOE).
• Participant's clinical diagnosis must be consistent with glaucoma characterized by the following features: Mean deviation (MD) of -3 to -20 dB on Humphrey Visual Field 24-2 testing and two visual field tests of adequate quality with a maximum VFI variability of ± 10%
• Residual visual field preservation including best-corrected visual acuity (BCVA) better than 20/200 in either eye.
• Participant's eye pressure must be clinically stable, with IOP \<21.
• If a participant has two eyes meeting study criteria, the worse eye as determined by visual field index (VFI) or patient preference, will be deemed includable. If both eyes qualify and have the same VFI, a randomization procedure will assign one eye to the study.
• Participant must understand and sign the informed consent. If the participant's vision is impaired to the point where he/she cannot read the informed consent document, the document will be read to the participant in its entirety.
• Females of childbearing potential must agree to use an effective form of birth control.
• Participant must be determined by the presurgical anesthesia or medical team to be fit for ophthalmic surgery for the NT-501 ECT implant insertion.

You may not qualify if:

• Participant is unable to comply with study procedures or followup visits.
• Participant has other optic nerve or retinal degenerative disease causing vision loss, irrespective of whether it is currently treated or untreated.
• Participant is likely to be offered glaucoma surgery in the study eye within 6 months of screening.
• Participant has cataract-associated vision loss to less than 20/40.
• Participant has a history of ocular herpes zoster.
• Participant has a requirement of acyclovir and/or related products during study duration. To be eligible for this study, the participant must discontinue use of these products prior to enrollment and must not continue with the products until after they have completed the study.
• Participant has evidence of corneal opacification or lack of optical clarity.
• Participant has uveitis or other ocular inflammatory disease.
• Participant is receiving systemic steroids or other immunosuppressive medications.
• Participant has diabetic macular edema and/or diabetic retinopathy.
• Participant has myopic degeneration.
• Participant is currently participating in or has within the last 3 months participated in any other clinical trial of a drug by ocular (if in the study eye) or systemic administration.
• Participant is pregnant or lactating.
• Participant is on chemotherapy.
• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Byers Eye Institute at Stanford University

Palo Alto, California, 94303, United States

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Jeffrey L Goldberg, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 25, 2020
• First Posted: October 6, 2020
• Study Start: May 15, 2021
• Primary Completion: August 15, 2025
• Study Completion (Estimated): August 15, 2026
• Last Updated: November 4, 2025

Record last verified: 2025-11

Locations

US (1)