Back to resultsNT-501 CNTF Implant for Ischemic Optic Neuropathy: Safety, Neuroprotection and Neuroenhancement
Primary Purpose
Ischemic Optic Neuropathy/Optic Nerve Stroke
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NT-501 CNTF Implant
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Optic Neuropathy/Optic Nerve Stroke
Eligibility 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.
Sites / Locations
- Bascom Palmer Eye Institute, University of Miami Miller School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NT-501 CNTF Implant
Arm Description
Patients will receive single NT-501 CNTF implant in one eye
Outcomes
Primary Outcome Measures
Safety: Number of patients with adverse events
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
Structural efficacy: Nerve fiber layer, optic nerve topography
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01411657
Brief Title
NT-501 CNTF Implant for Ischemic Optic Neuropathy: Safety, Neuroprotection and Neuroenhancement
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jeffrey L Goldberg
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Optic Neuropathy/Optic Nerve Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NT-501 CNTF Implant
Arm Type
Experimental
Arm Description
Patients will receive single NT-501 CNTF implant in one eye
Intervention Type
Drug
Intervention Name(s)
NT-501 CNTF Implant
Intervention Description
Single implantation of CNTF-secreting NT-501 device into one eye
Primary Outcome Measure Information:
Title
Safety: Number of patients with adverse events
Description
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.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Functional Efficacy: Vision, Visual Field, Pattern Electroretinogram, Visual Field Questionnaire-25
Time Frame
18 months
Title
Structural efficacy: Nerve fiber layer, optic nerve topography
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Bascom Palmer Eye Institute, University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Learn more about this trial
NT-501 CNTF Implant for Ischemic Optic Neuropathy: Safety, Neuroprotection and Neuroenhancement
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