Clinical trial NCT01389817: Near-infrared Light-emitting Diode (NIR-LED) Therapy for Leber's Hereditary Optic Neuropathy (LHON)
Official title: Near-infrared Light-emitting Diode (NIR-LED) Therapy for Leber's Hereditary Optic Neuropathy (LHON)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Leber's Hereditary Optic Neuropathy (LHON)
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2011-07-08
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: N95 Peak Via pERG and fERG -PhNR
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert Memorial Lutheran Hospital
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: The Eye Institute
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Harry T Whelan, MD
role: PRINCIPAL_INVESTIGATOR
References: