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

Stopped early · Phase 1/Phase 2

Conditions studied: Leber's Hereditary Optic Neuropathy (LHON)

In brief

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).

Key facts

Study ID

NCT01389817

Run by

Medical College of Wisconsin

People needed

4

Starts

2011-07-01

Expected to finish

2013-05-01

Last updated by the study team

2014-09-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Froedtert Memorial Lutheran Hospital — Milwaukee, Wisconsin, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• The Eye Institute — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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