- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01389817
Near-infrared Light-emitting Diode (NIR-LED) Therapy for Leber's Hereditary Optic Neuropathy (LHON) (LHON)
September 23, 2014 updated by: Harry T Whelan, MD, Medical College of Wisconsin
The overall objective of the proposed research is to test the hypothesis that Near-infrared Light-emitting Diode (NIR-LED) therapy will stimulate mitochondrial function, attenuate oxidative stress, and improve cell survival and vision in subjects with Leber's Hereditary Optic Neuropathy (LHON).
Study Overview
Status
Terminated
Conditions
Detailed Description
To determine the effects of short term (3 month) near-infrared light NIR-LED therapy on anatomic and functional abnormalities of LHON as assessed by a wide variety of ophthalmologic tests, including visual acuity, optical coherence tomography, pattern electroretinography (pERG) N95 retinal ganglion cell peak, fERG-PhNR (flash ERG - Photopic Negative Response), and fundus photography.
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Phase 2
- 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
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Froedtert Memorial Lutheran Hospital
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Milwaukee, Wisconsin, United States, 53226
- The Eye Institute
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Sex - male and female. Men are affected with visual loss more frequently than women, with a male predominance of ~85%. A minimum of 25% of men and 5% of women at risk for LHON experience visual loss.
- Age - 18 years or older. The onset of visual loss typically occurs between the ages of 15 and 35 years, but otherwise classic LHON has been reported in many individuals both younger and older, with a range of age at onset from 2 to 80 years.
- Diagnosis of LHON or a carrier of the gene mutation. Patient must be evaluated by molecular confirmation, with the 11778 and other mutations of Leber's Hereditary Optic Neuropathy stratified in later data analysis.
- Able & willing to provide informed consent
Exclusion Criteria:
- Has an optic nerve disease other than LHON.
- Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
- Participation in an investigational trial within 30 days of NIR-LED treatment that involved treatment with any drug that has not received regulatory approval at the time of study entry. (Note: subjects cannot receive another investigational drug while participating in the study during the first 6 months.)
- Major surgery within 28 days prior to participation or major surgery planned during the next 6 months. Major surgery is defined as a surgical procedure that is more extensive than fine needle biopsy/aspiration, placement of a central venous access device, removal/biopsy of a skin lesion, or placement of a peripheral venous catheter.
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: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Symptomatic LHON patients.
Study Arm 1) symptomatic LHON patients.
Male and female LHON patients with treatable bilateral optic atrophy.
Treat the worse of the 2 eyes if there is a measurable difference in subjective visual functions (visual acuity, peripheral vision).
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Subjects will be exposed to light emitted from a Med Light 630 PRO (Medical Devices Inc.) at a wavelength of 630 nm (+/-15nm) with an exposure of 4 J/cm2.
This is accomplished by applying the 50 mW/cm2 LED-generated light to the closed study eye for 80 seconds.
Treatments involve application of the LED-generated light for 80 seconds, twice daily.
Other Names:
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No Intervention: Asymptomatic LHON mutation carriers
Study Arm 2) asymptomatic LHON mutation carriers.
Can be male or female; have some dysfunction, with changes occurring over months.
Patients in study arm 2 will not be exposed to NIR-LED, but only undergo diagnostic studies.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
N95 Peak Via pERG and fERG -PhNR
Time Frame: 12 months
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The primary comparison will be a paired comparison of pre- and post-treatment retinal ganglion cell N95 pattern electroretinogram (pERG) peaks and fERG - Photopic Negative Response (PhNR).
Pairing will be done between a subject's treatment and control eye.
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Harry T Whelan, MD, Medical College of Wisconsin
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
July 1, 2011
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
July 6, 2011
First Submitted That Met QC Criteria
July 7, 2011
First Posted (Estimate)
July 8, 2011
Study Record Updates
Last Update Posted (Estimate)
September 29, 2014
Last Update Submitted That Met QC Criteria
September 23, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Nervous System Diseases
- Eye Diseases
- Genetic Diseases, Inborn
- Neurodegenerative Diseases
- Eye Diseases, Hereditary
- Heredodegenerative Disorders, Nervous System
- Cranial Nerve Diseases
- Optic Atrophies, Hereditary
- Optic Atrophy
- Mitochondrial Diseases
- Optic Nerve Diseases
- Optic Atrophy, Hereditary, Leber
Other Study ID Numbers
- PRO14842
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 Leber's Hereditary Optic Neuropathy (LHON)
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Santhera PharmaceuticalsCompletedLeber's Hereditary Optic Neuropathy (LHON)Italy, Germany, France, Austria, Greece, Netherlands
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Wuhan Neurophth Biotechnology Limited CompanyRecruitingLeber's Hereditary Optic Neuropathy (LHON)China
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Santhera PharmaceuticalsCompletedLeber's Hereditary Optic Neuropathy (LHON)United States, United Kingdom, Spain, Poland, Austria, Belgium, Bulgaria, Germany, Italy, Portugal
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Santhera PharmaceuticalsCompletedLeber's Hereditary Optic Neuropathy (LHON)Belgium, Netherlands, France, Germany, Norway, United Kingdom, Italy
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Santhera PharmaceuticalsEuropean Vision Institute Clinical Research NetworkCompletedLeber Hereditary Optic Neuropathy (LHON)Belgium, France, Denmark, Italy, Slovenia
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Neurophth Therapeutics IncRecruitingLeber Hereditary Optic Neuropathy (LHON)China, United States
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Argo SanteGenSight BiologicsCompleted
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Neurophth Therapeutics IncActive, not recruitingLeber Hereditary Optic Neuropathy (LHON)United States
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University Hospital, AngersUnknownLeber Hereditary Optic NeuropathyFrance
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GenSight BiologicsCompletedLeber Hereditary Optic NeuropathyUnited States, France, Italy, United Kingdom, Germany