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Near-infrared Light-emitting Diode (NIR-LED) Therapy for Leber's Hereditary Optic Neuropathy (LHON) (LHON)

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ClinicalTrials.gov Identifier: NCT01389817
Recruitment Status : Terminated (Unable to record n95 pERG peak (primary measure), as LHON subjects are unable to focus on target.)
First Posted : July 8, 2011
Results First Posted : September 29, 2014
Last Update Posted : September 29, 2014
Sponsor:
Information provided by (Responsible Party):
Harry T Whelan, MD, Medical College of Wisconsin

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Leber's Hereditary Optic Neuropathy (LHON)
Intervention Device: Near-infrared light-emitting diode (NIR-LED) therapy (Med Light 630 PRO (Medical Devices Inc.))
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Symptomatic LHON Patients. Asymptomatic LHON Mutation Carriers
Hide Arm/Group Description

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).

Near-infrared light-emitting diode (NIR-LED) therapy (Med Light 630 PRO (Medical Devices Inc.)): 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.

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.
Period Title: Overall Study
Started 4 0
Completed 0 0
Not Completed 4 0
Reason Not Completed
Physician Decision             1             0
Lost to Follow-up             1             0
Withdrawal by Subject             2             0
Arm/Group Title Symptomatic LHON Patients. Asymptomatic LHON Mutation Carriers Total
Hide Arm/Group Description

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).

Near-infrared light-emitting diode (NIR-LED) therapy (Med Light 630 PRO (Medical Devices Inc.)): 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.

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. Total of all reporting groups
Overall Number of Baseline Participants 4 0 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4 participants 0 participants 4 participants
<=18 years 0 0
Between 18 and 65 years 4 4
>=65 years 0 0
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4 participants 0 participants 4 participants
Female 0 0
Male 4 4
Race (NIH/OMB)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4 participants 0 participants 4 participants
American Indian or Alaska Native 0 0
Asian 0 0
Native Hawaiian or Other Pacific Islander 0 0
Black or African American 0 0
White 4 4
More than one race 0 0
Unknown or Not Reported 0 0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 0 participants 4 participants
4 4
1.Primary Outcome
Title N95 Peak Via pERG and fERG -PhNR
Hide Description 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.
Time Frame 12 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Symptomatic LHON Patients. Asymptomatic LHON Mutation Carriers
Hide Arm/Group Description

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).

Near-infrared light-emitting diode (NIR-LED) therapy (Med Light 630 PRO (Medical Devices Inc.)): 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.

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.
All-Cause Mortality
Symptomatic LHON Patients. Asymptomatic LHON Mutation Carriers
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Symptomatic LHON Patients. Asymptomatic LHON Mutation Carriers
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Symptomatic LHON Patients. Asymptomatic LHON Mutation Carriers
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Harry T. Whelan M.D.
Organization: Medical College of Wisconsin
Phone: 414-266-3466
Responsible Party: Harry T Whelan, MD, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT01389817     History of Changes
Other Study ID Numbers: PRO14842
First Submitted: July 6, 2011
First Posted: July 8, 2011
Results First Submitted: September 23, 2014
Results First Posted: September 29, 2014
Last Update Posted: September 29, 2014