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

NCT01389817 | Terminated Phase 1 Results

• 1 other identifier: PRO14842
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 3

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).

Conditions

Leber's Hereditary Optic Neuropathy (LHON)

Outcome Measures

Primary Outcomes (1)

• N95 Peak Via pERG and fERG -PhNR

  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.

  12 months

Study Arms (2)

Symptomatic LHON patients.

EXPERIMENTAL

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.))

Asymptomatic LHON mutation carriers

NO INTERVENTION

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.

Interventions

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

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.

Also known as: Med Light 630 PRO (Medical Devices Inc.)

Symptomatic LHON patients.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (3)

Froedtert Memorial Lutheran Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

The Eye Institute

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Optic Atrophy, Hereditary, Leber

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Optic Atrophies, Hereditary; Optic Atrophy; Optic Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Eye Diseases, Hereditary; Eye Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Mitochondrial Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Harry T. Whelan M.D.
• Organization: Medical College of Wisconsin

hwhelan@mcw.edu

414-266-3466

Study Officials

• Harry T Whelan, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bleser Professor of Neurology

Study Record Dates

• First Submitted: July 6, 2011
• First Posted: July 8, 2011
• Study Start: July 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: September 29, 2014
• Results First Posted: September 29, 2014

Record last verified: 2014-09

Locations

US (3)