Ischemic Optic Neuropathy/Optic Nerve StrokePhase 1NCT01411657
NT-501 CNTF Implant for Ischemic Optic Neuropathy: Safety, Neuroprotection and Neuroenhancement
A Phase 1 study testing NT-501 CNTF Implant in people with Ischemic Optic Neuropathy/Optic Nerve Stroke, run by Jeffrey L Goldberg at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Ischemic Optic Neuropathy/Optic Nerve Stroke
- What is being tested?
- NT-501 CNTF Implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Oct 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bascom Palmer Eye Institute, University of Miami Miller School of Medicine
Miami, Florida, 33136
About this study
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.
- Being tested
- NT-501 CNTF Implant
- Medical subject headings
- Optic Neuropathy, Ischemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NT-501 CNTF ImplantDrug
Single implantation of CNTF-secreting NT-501 device into one eye
| Study group | Role | What they receive |
|---|---|---|
| NT-501 CNTF Implant | Experimental | Patients will receive single NT-501 CNTF implant in one eye Receives: Drug: NT-501 CNTF Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (2)
Functional Efficacy: Vision, Visual Field, Pattern Electroretinogram, Visual Field Questionnaire-25
Measured: 18 months
Structural efficacy: Nerve fiber layer, optic nerve topography
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2013
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Optic Neuropathy/Optic Nerve StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeffrey L Goldberg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jeffrey L Goldberg, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01411657
- Sponsor's protocol ID
- 20090300
- Status last verified
- Aug 2016
- First submitted
- 5 Aug 2011
- Last updated
- 2 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NT-501 CNTF Implant for Ischemic Optic Neuropathy: Safety, Neuroprotection and Neuroenhancement
- ClinicalTrials.gov ID
- NCT01411657
- Acronym / sponsor ID
- 20090300
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Jeffrey L GoldbergUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 8 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NT-501 CNTF Implant | Experimental | Drug: NT-501 CNTF ImplantPatients will receive single NT-501 CNTF implant in one eye |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NT-501 CNTF ImplantSingle implantation of CNTF-secreting NT-501 device into one eye | Drug | NT-501 CNTF Implant |
Primary outcome
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.
2 secondary outcomes
Functional Efficacy: Vision, Visual Field, Pattern Electroretinogram, Visual Field Questionnaire-25
Time frame: 18 months
Structural efficacy: Nerve fiber layer, optic nerve topography
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2016.
Related trials for Ischemic Optic Neuropathy/Optic Nerve Stroke
Recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NT-501 CNTF Implant in people with Ischemic Optic Neuropathy/Optic Nerve Stroke, run by Jeffrey L Goldberg at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Number of patients with adverse events (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2016.