A Randomized, Sham Controlled, Masked Phase II Study to Evaluate the Safety and Efficacy of Dual Intravitreal Implantation of NT-501 Encapsulated Cell Therapy for the Treatment of Glaucoma

Who is this study for? Patients with glaucoma
What treatments are being studied? NT-501
Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
Byers Eye Institute at Stanford University
RECRUITING
Palo Alto
Contact Information
Primary
Mariana Nunez, MD
mnunez@stanford.edu
6504977846
Time Frame
Start Date: 2021-05-15
Estimated Completion Date: 2025-12-15
Participants
Target number of participants: 30
Treatments
Experimental: Dual Implantation
Two NT-501 devices will be implanted in the study eye.
Experimental: Single Implantation
One NT-501 device will be implanted in the study eye.
Sham_comparator: Sham Implantation
No NT-501 devices will be implanted in the study eye.
Related Therapeutic Areas
Sponsors
Leads: Stanford University

This content was sourced from clinicaltrials.gov