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NT-501 CNTF Implant for Ischemic Optic Neuropathy: Safety, Neuroprotection and Neuroenhancement

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01411657
First Posted: August 8, 2011
Last Update Posted: August 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jeffrey L Goldberg, Stanford University
  Purpose
Ciliary Neurotrophic Factor (CNTF) has been demonstrated in multiple preclinical models to enhance survival and regeneration of retinal ganglion cells, the retinal neurons injured in diseases like ischemic optic neuropathy/optic nerve stroke. We hypothesize that CNTF delivery to the human eye will provide neuroprotection (prevent loss of vision) and neuroenhancement (improve vision indices) in ischemic optic neuropathy. 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
Ischemic Optic Neuropathy/Optic Nerve Stroke Drug: NT-501 CNTF Implant Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Safety: Number of patients with adverse events [ Time Frame: 18 months ]
    Safety will be evaluated by determining 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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 40 years or older
  • 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 ischemic optic neuropathy characterized by (a) non-arteritic subtype, including a normal ESR and CRP; (b) syndrome of acute unilateral visual loss with documented optic nerve head edema but without significant pain; (c) a relative afferent papillary defect in the affected eye, and a decrease of best-corrected visual acuity to 20/40 or worse in the affected eye, and detectable loss on visual field testing consistent with nerve fiber visual field defect but retaining measurable residual visual field preservation.

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
Information from the National Library of Medicine

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): NCT01411657


Locations
United States, Florida
Bascom Palmer Eye Institute, University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
Sponsors and Collaborators
Jeffrey L Goldberg
  More Information

Responsible Party: Jeffrey L Goldberg, Associate Professor of Ophthalmology, Stanford University
ClinicalTrials.gov Identifier: NCT01411657     History of Changes
Other Study ID Numbers: 20090300
First Submitted: August 5, 2011
First Posted: August 8, 2011
Last Update Posted: August 2, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Ischemia
Optic Nerve Diseases
Optic Neuropathy, Ischemic
Pathologic Processes
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases