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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jeffrey L. Goldberg, University of Miami
ClinicalTrials.gov Identifier:
NCT01411657
First received: August 5, 2011
Last updated: July 26, 2012
Last verified: July 2012
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Safety: Number of patients with adverse events [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • Structural efficacy: Nerve fiber layer, optic nerve topography [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: June 2011
Estimated Study Completion Date: December 2013
Estimated 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:   40 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Jeffrey L. Goldberg, Associate Professor of Ophthalmology, University of Miami
ClinicalTrials.gov Identifier: NCT01411657     History of Changes
Other Study ID Numbers: 20090300
Study First Received: August 5, 2011
Last Updated: July 26, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013