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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01389817 |
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Date of registration:
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06/07/2011 |
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Primary sponsor: |
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Public title:
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Near-infrared Light-emitting Diode (NIR-LED) Therapy for Leber's Hereditary Optic Neuropathy (LHON)
LHON |
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Scientific title:
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Near-infrared Light-emitting Diode (NIR-LED) Therapy for Leber's Hereditary Optic Neuropathy (LHON) |
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Date of first enrolment:
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July 2011 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01389817 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Debbie Dye |
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Address:
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Telephone:
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414-266-7544 |
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Email:
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ddye@mcw.edu |
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Affiliation:
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Name:
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Harry T Whelan, MD |
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Address:
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Telephone:
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414-266-7544 |
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Email:
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hwhelan@mcw.edu |
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Affiliation:
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Name:
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Harry T Whelan, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medical College of Wisconsin |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Leber's Hereditary Optic Neuropathy (LHON)
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Intervention(s)
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Device: Near-infrared light-emitting diode (NIR-LED) therapy (Med Light 630 PRO (Medical Devices Inc.))
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Primary Outcome(s)
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N95 peak via pERG and fERG -PhNR
[Time Frame: 12 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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