Near-infrared Light (NIR) Therapy for Diabetic Macular Edema: A Pilot Study
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.
Diabetic Macular Edema
Device: Warp 10 LED Device
Device: Near-infrared light (NIR)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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.|
- Excess retinal thickness on OCT at 1 month, 3 months and 6 months. goal = reduce excess thickness by at least 50% [ Time Frame: 1 month, 3 months and 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||November 2007|
|Estimated Study Completion Date:||September 2012|
|Estimated Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
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
Study Subjects will take the Warp 10 (LED) home and treat twice per day for three months
Other Name: Warp 10Device: Near-infrared light (NIR)
Other Name: Warp 10 LED's
|Contact: Harry T Whelan, MDfirstname.lastname@example.org|
|United States, Wisconsin|
|Medical College of Wisconsin||Recruiting|
|Milwaukee, Wisconsin, United States, 53226|
|Contact: Harry T Whelan, MD 414-266-7544 email@example.com|
|Principal Investigator: Harry T Whelan, MD|
|Principal Investigator:||Harry T Whelan, MD||Medical College of Wisconsin|