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

This study has been terminated.
(Unable to record n95 pERG peak (primary measure), as LHON subjects are unable to focus on target.)
Sponsor:
Information provided by (Responsible Party):
Harry T Whelan, MD, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT01389817
First received: July 6, 2011
Last updated: September 23, 2014
Last verified: September 2014
Results First Received: September 23, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: 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.))

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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).

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.

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.

Participant Flow:   Overall Study
    Symptomatic LHON Patients.     Asymptomatic LHON Mutation Carriers  
STARTED     4     0  
COMPLETED     0     0  
NOT COMPLETED     4     0  
Physician Decision                 1                 0  
Lost to Follow-up                 1                 0  
Withdrawal by Subject                 2                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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).

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.

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.
Total Total of all reporting groups

Baseline Measures
    Symptomatic LHON Patients.     Asymptomatic LHON Mutation Carriers     Total  
Number of Participants  
[units: participants]
  4     0     4  
Age  
[units: participants]
     
<=18 years     0         0  
Between 18 and 65 years     4         4  
>=65 years     0         0  
Gender  
[units: participants]
     
Female     0         0  
Male     4         4  
Race (NIH/OMB)  
[units: 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  
[units: participants]
     
United States     4         4  



  Outcome Measures

1.  Primary:   N95 Peak Via pERG and fERG -PhNR   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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
e-mail: hwhelan@mcw.edu


No publications provided


Responsible Party: Harry T Whelan, MD, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT01389817     History of Changes
Other Study ID Numbers: PRO14842
Study First Received: July 6, 2011
Results First Received: September 23, 2014
Last Updated: September 23, 2014
Health Authority: United States: Institutional Review Board