- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01411657
NT-501 CNTF Implant for Ischemic Optic Neuropathy: Safety, Neuroprotection and Neuroenhancement
August 1, 2016 updated by: Jeffrey L Goldberg
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
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Miami, Florida, United States, 33136
- Bascom Palmer Eye Institute, University of Miami Miller School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NT-501 CNTF Implant
Patients will receive single NT-501 CNTF implant in one eye
|
Single implantation of CNTF-secreting NT-501 device into one eye
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Functional Efficacy: Vision, Visual Field, Pattern Electroretinogram, Visual Field Questionnaire-25
Time Frame: 18 months
|
18 months
|
Structural efficacy: Nerve fiber layer, optic nerve topography
Time Frame: 18 months
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
August 5, 2011
First Submitted That Met QC Criteria
August 5, 2011
First Posted (Estimate)
August 8, 2011
Study Record Updates
Last Update Posted (Estimate)
August 2, 2016
Last Update Submitted That Met QC Criteria
August 1, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20090300
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ischemic Optic Neuropathy/Optic Nerve Stroke
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Shahid Beheshti University of Medical SciencesUnknownAcute Nonarteritic Anterior Ischemic Optic NeuropathyIran, Islamic Republic of
-
Rigshospitalet, DenmarkUniversity of Colorado, Denver; King's College Hospital NHS Trust; Odense University... and other collaboratorsRecruitingNon-arteritic Ischemic Optic Neuropathy | Optic Disk DrusenDenmark, United Kingdom, United States, Australia, Canada, France, Iran, Islamic Republic of, Israel, New Zealand
-
Shahid Beheshti University of Medical SciencesUnknownNon-Arteritic Anterior Ischemic Optic Neuropathy (NAION)Iran, Islamic Republic of
-
Instituto Universitario de Oftalmobiología Aplicada...University of ValladolidActive, not recruitingNon Arteritic Ischemic Optic NeuropathySpain
-
Fraser HealthWithdrawnIschemic Optic Neuropathy | Optic Neuropathy, Ischemic | Anterior Ischemic Optic Neuropathy | Optic Neuropathy, Anterior IschemicCanada
-
Shahid Beheshti University of Medical SciencesUnknownNAION( Non-arteritic Anterior Ischemic Optic Neuropathy)Iran, Islamic Republic of
-
Eli Lilly and CompanyCompletedNonarteritic Anterior Ischemic Optic NeuropathyUnited States
-
Omar SaidCompletedNon-arteritic Ischemic Optic NeuropathyEgypt
-
University Hospital TuebingenUniversity Hospital FreiburgCompletedNon-arteritic Ischemic Optic NeuropathyGermany
-
Shahid Beheshti University of Medical SciencesCompletedNonarteritic Anterior Ischemic Optic NeuropathyIran, Islamic Republic of
Clinical Trials on NT-501 CNTF Implant
-
Neurotech PharmaceuticalsCompletedRetinitis PigmentosaUnited States
-
Neurotech PharmaceuticalsThe Lowy Medical Research Institute LimitedCompletedMacular Telangiectasia Type 2United States, Australia
-
Neurotech PharmaceuticalsCompletedRetinitis PigmentosaUnited States
-
Jeffrey L GoldbergCompletedGlaucoma, Primary Open AngleUnited States
-
National Eye Institute (NEI)Completed
-
Neurotech PharmaceuticalsThe Emmes Company, LLC; The Lowy Medical Research Institute LimitedCompletedMacular Telangiectasia Type 2United States, Australia
-
Neurotech PharmaceuticalsUniversity of California, San FranciscoCompletedRetinitis Pigmentosa | Usher Syndrome Type 2 | Usher Syndrome Type 3United States
-
Neurotech PharmaceuticalsCompletedMacular DegenerationUnited States
-
National Eye Institute (NEI)CompletedRetinitis PigmentosaUnited States
-
Neurotech PharmaceuticalsThe Lowy Medical Research Institute LimitedCompletedIdiopathic Juxtafoveal TelangiectasiaUnited States