Trial Outcomes & Findings for Near-infrared Light-emitting Diode (NIR-LED) Therapy for Leber's Hereditary Optic Neuropathy (LHON) (NCT NCT01389817)
NCT ID: NCT01389817
Last Updated: 2014-09-29
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
4 participants
Primary outcome timeframe
12 months
Results posted on
2014-09-29
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Near-infrared Light-emitting Diode (NIR-LED) Therapy for Leber's Hereditary Optic Neuropathy (LHON)
Baseline characteristics by cohort
| Measure |
Symptomatic LHON Patients.
n=4 Participants
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
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 participants
n=5 Participants
|
—
|
4 participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Gender
Female
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Gender
Male
|
4 participants
n=5 Participants
|
—
|
4 participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 participants
n=5 Participants
|
—
|
4 participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
—
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: All participants were withdrawn before any data could be obtained.
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.
Outcome measures
Outcome data not reported
Adverse Events
Symptomatic LHON Patients.
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Asymptomatic LHON Mutation Carriers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place