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History of Changes for Study: NCT01389817
Near-infrared Light-emitting Diode (NIR-LED) Therapy for Leber's Hereditary Optic Neuropathy (LHON) (LHON)
Latest version (submitted September 23, 2014) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 7, 2011 None (earliest Version on record)
2 April 18, 2012 Recruitment Status, Sponsor/Collaborators, Study Status, Contacts/Locations and Oversight
3 August 21, 2013 Recruitment Status, Study Status, Contacts/Locations and Study Design
4 September 23, 2014 Study Status, Results and Outcome Measures
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Study NCT01389817
Submitted Date:  July 7, 2011 (v1)

Open or close this module Study Identification
Unique Protocol ID: PRO14842
Brief Title: Near-infrared Light-emitting Diode (NIR-LED) Therapy for Leber's Hereditary Optic Neuropathy (LHON) (LHON)
Official Title: Near-infrared Light-emitting Diode (NIR-LED) Therapy for Leber's Hereditary Optic Neuropathy (LHON)
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2011
Overall Status: Not yet recruiting
Study Start: July 2011
Primary Completion: June 2013 [Anticipated]
Study Completion: June 2014 [Anticipated]
First Submitted: July 6, 2011
First Submitted that
Met QC Criteria:
July 7, 2011
First Posted: July 8, 2011 [Estimate]
Last Update Submitted that
Met QC Criteria:
July 7, 2011
Last Update Posted: July 8, 2011 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Medical College of Wisconsin
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: 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).
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.
Open or close this module Conditions
Conditions: Leber's Hereditary Optic Neuropathy (LHON)
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 60 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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).
Device: 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.
Other Names:
  • Med Light 630 PRO (Medical Devices Inc.)
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.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. N95 peak via pERG and fERG -PhNR
[ Time Frame: 12 months ]

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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

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.
Open or close this module Contacts/Locations
Central Contact Person: Harry T Whelan, MD
Telephone: 414-266-7544
Email: hwhelan@mcw.edu
Central Contact Backup: Debbie Dye
Telephone: 414-256-7544
Email: ddye@mcw.edu
Study Officials: Harry T Whelan, MD
Principal Investigator
Medical College of Wisconsin
Locations: United States, Wisconsin
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, United States, 53226
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
The Eye Institute
Milwaukee, Wisconsin, United States, 53226
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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