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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Jeffrey L Goldberg, Stanford University

ClinicalTrials.gov Identifier:

NCT01408472

First received: August 2, 2011

Last updated: August 1, 2016

Last verified: August 2016

History of Changes

Purpose

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.

Condition	Intervention	Phase
Glaucoma, Primary Open Angle	Drug: NT-501 CNTF Implant	Phase 1


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	CNTF Cell Implants For Glaucoma: A Phase I Study

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

U.S. FDA Resources

Further study details as provided by Jeffrey L Goldberg, Stanford University:

Primary Outcome Measures:

Safety: Number of adverse events [ Time Frame: 18 months ]
Safety will be evaluated by counting the number of patients with adverse events, including loss of vision, visual field, or retinal/optic nerve structure, and ocular complications such as pain and inflammation.

Secondary Outcome Measures:

Functional Efficacy: Vision, Visual Field, Pattern Electroretinogram; Visual Field Questionnaire-25 [ Time Frame: 18 months ]
Structural Efficacy: Nerve fiber layer, optic nerve topography [ Time Frame: 18 months ]


Enrollment:	11
Study Start Date:	April 2011
Study Completion Date:	October 2014
Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: NT-501 CNTF Implant Patients will receive single NT-501 CNTF implant in one eye.	Drug: NT-501 CNTF Implant Single implantation of CNTF-secreting NT-501 device into one eye

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01408472

Locations


United States, Florida
Bascom Palmer Eye Institute, University of Miami
Miami, Florida, United States, 33136

Sponsors and Collaborators

Jeffrey L Goldberg

Investigators


Principal Investigator:	Jeffrey L Goldberg, MD, PhD	Bascom Palmer Eye Institute, University of Miami

More Information


Responsible Party:	Jeffrey L Goldberg, Associate Professor of Ophthalmology, Stanford University
ClinicalTrials.gov Identifier:	NCT01408472 History of Changes
Other Study ID Numbers:	20090257
Study First Received:	August 2, 2011
Last Updated:	August 1, 2016

Additional relevant MeSH terms:


Glaucoma Glaucoma, Open-Angle Ocular Hypertension Eye Diseases

ClinicalTrials.gov processed this record on July 07, 2017

To Top