Dual Intravitreal Implantation of NT-501 Encapsulated Cell Therapy for Glaucoma
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|ClinicalTrials.gov Identifier: NCT04577300|
Recruitment Status : Recruiting
First Posted : October 6, 2020
Last Update Posted : November 16, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Glaucoma||Drug: NT-501 Other: Sham comparator||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||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|
|Actual Study Start Date :||May 15, 2021|
|Estimated Primary Completion Date :||August 15, 2024|
|Estimated Study Completion Date :||December 15, 2024|
Experimental: Dual Implantation
Two NT-501 devices will be implanted in the study eye.
Implant of Neurotech NT-501 device(s)
Experimental: Single Implantation
One NT-501 device will be implanted in the study eye.
Implant of Neurotech NT-501 device(s)
Sham Comparator: Sham Implantation
No NT-501 devices will be implanted in the study eye.
Other: Sham comparator
- Visual Field MD at 12 Months [ Time Frame: 12 months ]Change from baseline in visual field through 12 months as assessed by Mean Deviation (MD).
- Visual Field Index at 12 months [ Time Frame: 12 months ]Change from baseline in visual field through 12 months as assessed by Visual Field Index (VFI).
- Visual Field PLR at 12 months [ Time Frame: 12 months ]Change from baseline in visual field pointwise linear regression (PLR) through 12 months.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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 a history of malignancy other than basal cell carcinoma, unless it was treated successfully 2 years prior to inclusion in the trial.
- 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.
- Any intraocular surgery of the study eye within 12 weeks prior to the screening visit
- History of use of drugs with known retinal toxicity, at retinotoxic doses.
- Patient has a history of multiple sclerosis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04577300
|Contact: Mariana Nunez, MDfirstname.lastname@example.org|
|United States, California|
|Byers Eye Institute at Stanford University||Recruiting|
|Palo Alto, California, United States, 94303|
|Contact: Mariana Nunez 650-497-7846 email@example.com|
|Principal Investigator:||Jeffrey L Goldberg, MD, PhD||Stanford University|
|Responsible Party:||Jeffrey L Goldberg, Professor, Stanford University|
|Other Study ID Numbers:||
|First Posted:||October 6, 2020 Key Record Dates|
|Last Update Posted:||November 16, 2022|
|Last Verified:||November 2022|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|