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

Sponsor

Jeffrey L Goldberg (Other)

Overall Status

Completed

CT.gov ID

NCT01411657

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Optic Neuropathy/Optic Nerve Stroke	Drug: NT-501 CNTF Implant	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

11 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Apr 1, 2011

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Safety: Number of patients with adverse events [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 [18 months]
Structural efficacy: Nerve fiber layer, optic nerve topography [18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Bascom Palmer Eye Institute, University of Miami Miller School of Medicine	Miami	Florida	United States	33136

Sponsors and Collaborators

Jeffrey L Goldberg

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jeffrey L Goldberg, Associate Professor of Ophthalmology, Stanford University

ClinicalTrials.gov Identifier:

NCT01411657

Other Study ID Numbers:

20090300

First Posted:

Aug 8, 2011

Last Update Posted:

Aug 2, 2016

Last Verified:

Aug 1, 2016

Additional relevant MeSH terms:

Optic Nerve Diseases

Optic Neuropathy, Ischemic

Ischemia

Study Results

No Results Posted as of Aug 2, 2016