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NT-501 CNTF Implant for Glaucoma: Safety, Neuroprotection and Neuroenhancement | Clinical Trials | Clareo Health

COMPLETEDPHASE1

NT-501 CNTF Implant for Glaucoma: Safety, Neuroprotection and Neuroenhancement

CNTF Cell Implants For Glaucoma: A Phase I Study

NCT01408472•Jeffrey L Goldberg

Summary

Ciliary Neurotrophic Factor (CNTF) has been demonstrated in multiple pre-clinical models to enhance survival and regeneration of retinal ganglion cells, the retinal neurons injured in diseases like glaucoma. We hypothesize that CNTF delivery to the human eye will provide neuroprotection (prevent loss of vision) and neuroenhancement (improve vision indices) in glaucoma. Patients in the trial will receive an NT-501 CNTF implant (made by Neurotech) into one eye, and will be carefully followed to evaluate safety and efficacy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•must understand and sign the informed consent
•must be medically able to undergo ophthalmic surgery for the NT-501 device insertion and possible removal, as well as the testing required.
•diagnosis of glaucoma characterized by (a) clinical evidence of progressive RGC dysfunction and degeneration using both visual field and at least one structural modality; (b) residual visual field preservation including best-corrected visual acuity (BCVA) better than 20/100; (c) failure to contain glaucomatous progression with maximally tolerated reduction of intraocular pressure (IOP), OR visual field defect affecting fixation, but not reducing BCVA below 20/100.

Exclusion Criteria

•other corneal, lens, optic nerve or retinal disease causing vision loss,
•blind in one eye
•requirement of acyclovir and/or related products during study
•receiving systemic steroids or other immunosuppressive medications.
•pregnant or lactating.
•considered immunodeficient or has a known history of human immunodeficiency virus (HIV)
•on chemotherapy, or a history of malignancy, UNLESS it was treated successfully 2 years prior to inclusion in the trial.

Locations (1)

Bascom Palmer Eye Institute, University of Miami

Miami, Florida, United States

Key Dates

Start Date

April 1, 2011

Primary Completion Date

December 1, 2013

Completion Date

October 1, 2014

Last Updated

August 2, 2016

Enrollment

ACTUAL participants

Conditions

Glaucoma, Primary Open Angle

Interventions

NT-501 CNTF Implant

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 2, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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NT-501 CNTF Implant for Glaucoma: Safety, Neuroprotection and Neuroenhancement

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Exclusion Criteria

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