Near-infrared Light (NIR) Therapy for Diabetic Macular Edema: A Pilot Study

Study Overview
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Brief Summary
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Summary of Study Rationale Near-infrared light (NIR) via light-emitting diodes (LED) treatment promotes retinal healing and improve visual function following high intensity laser retinal injury by augmenting cellular energy metabolism, enhances mitochondrial function, increases cytochrome C oxidase activity, stimulates antioxidant protective pathways, and promotes cell survival. LED directly benefits injured neurons in the retina, the lateral geniculate nucleus, and the visual cortex, where perception occurs. From a public health perspective, a Light-Emitting Diode (LED) Array study is important to conduct because it has been approved as a non-significant risk (NSR) device for treatment of eye disorders, it has a low cost of treatment, and it may serve as an effective, non-invasive alternative or adjunctive treatment to laser photocoagulation, the current standard of care for DME. Study Objectives and Hypotheses To determine the effects of short term (3 month) near-infrared light (NIR) therapy on anatomic and functional abnormalities of diabetic macular edema as assessed by visual acuity, optical coherence tomography, multifocal electroretinography (mERG) and fundus bimicroscopy. To assess safety of short term near-infrared light therapy in eyes with diabetic macular edema.

Official Title
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Phase 1 Study To Determine the Effects of Short Term Near-infrared Light (NIR) Therapy on Anatomic and Functional Abnormalities of Diabetic Macular Edema, and Assess Safety of Short Term Near-infrared Light Therapy in Eyes With Diabetic Macular Edema.

Conditions
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Diabetic Macular Edema

Intervention / Treatment
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* Device: Warp 10 LED Device
* Device: Near-infrared light (NIR)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >= 18 years Subjects <18 years old are not being included because DME is so rare in this age group that the diagnosis of DME may be questionable. Diagnosis of diabetes mellitus (type 1 or type 2) • Any one of the following will be considered to be sufficient evidence that diabetes is present: Current regular use of insulin for the treatment of diabetes Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes Documented diabetes by ADA and/or WHO criteria (see Procedures Manual for definitions) At least one eye meets the study eye criteria. Fellow eye meets criteria. Able and willing to provide informed consent. Any candidate identified by a study investigator as being able to successfully tolerate a 3 month deferral of laser photocoagulation. Exclusion Criteria: Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant. Subjects in poor glycemic control who, within the last 4 months, initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next 4 months should not be enrolled. Participation in an investigational trial within 30 days of NIR participation 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. Subject is expecting to move out of the area during the 6 months of the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device<br>The study will require 20 subjects. Each subject will have one study eye that will be designated for treatment. Subjects will be exposed to light emitted from Warp 10 LED's (Quantum Devices, Barneveld, WI) at wavelengths of 670 nm (+/-15nm) with a minimum exposure of 4 J/cm2 (4.0 - 7.68J/cm2). This is accomplished by applying the 50 mW/cm2 (50 - 80 mw/cm2) LED-generated light to the study eye. Treatments involve application of the LED-generated light for 80 seconds, twice daily. Primary efficacy and toxicity outcomes are determined by measuring excess retinal thickness via Ocular Coherence Tomography at 1 month, 3 months, and 6 months, prior to conclusion of the study. • This protocol will be stopped if, at any point in the study, a 50% increase in excess retinal thickness is demonstrated via OCT in 25% of subjects in the experimental group. | Device: Warp 10 LED Device<br>* Study Subjects will take the Warp 10 (LED) home and treat twice per day for three months<br>* Other names: Warp 10;Device: Near-infrared light (NIR)<br>* Subjects will be exposed to light emitted from LED's at wavelengths of 670 nm (+/-15nm) with a minimum exposure of 4 J/cm2 (4.0 - 7.68J/cm2). This is accomplished by applying the 50 mW/cm2 (50 - 80 mw/cm2) LED-generated light to the study eye. Treatments involve application of the LED-generated light for 80 seconds, twice daily.<br>* Other names: Warp 10 LED's;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Excess retinal thickness on OCT at 1 month, 3 months and 6 months. goal = reduce excess thickness by at least 50% |  | 1 month, 3 months and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Retinopathy, Diabetic Macular Edema, NIR, Near-infrared Light Therapy