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CompletedNCT01411657Updated Aug 2, 2016

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

A Phase 1 interventional study of NT-501 CNTF Implant in Ischemic Optic Neuropathy/Optic Nerve Stroke, sponsored by Jeffrey L Goldberg. Completed at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2016-08-02.

Sponsored by Jeffrey L Goldberg · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
11
Allocation
Not applicable
Ages
40 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Ischemic Optic Neuropathy/Optic Nerve Stroke
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In context

Optic Nerve Diseases

128 studies on the registry are indexed under Optic Nerve Diseases; 27 are open to participants now.

This study's enrollment of 11 is below the median of 40 across 84 interventional studies indexed under Optic Nerve Diseases.

Browse Optic Nerve Diseases studies →

Lead sponsor

Jeffrey L Goldberg is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Experimental
    NT-501 CNTF Implant

    Patients will receive single NT-501 CNTF implant in one eye

    Drug: NT-501 CNTF Implant

Interventions

  • DrugNT-501 CNTF Implant

    Single implantation of CNTF-secreting NT-501 device into one eye

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 18 months

Secondary outcomes

  1. Functional Efficacy: Vision, Visual Field, Pattern Electroretinogram, Visual Field Questionnaire-25

    Time frame: 18 months

  2. Structural efficacy: Nerve fiber layer, optic nerve topography

    Time frame: 18 months

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Study locations

1 site
  • Bascom Palmer Eye Institute, University of Miami Miller School of Medicine
    Miami, Florida 33136, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01411657
Lead sponsor
Jeffrey L Goldberg
Responsible party
Jeffrey L Goldberg (Associate Professor of Ophthalmology, Stanford University) — Sponsor-investigator
First posted
Aug 8, 2011
Start date
Apr 2011
Primary completion
Dec 2013
Completion
Oct 2014
Last update
Aug 2, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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