Near-infrared Light (NIR) Therapy for Diabetic Macular Edema: A Pilot Study (NIR)
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|ClinicalTrials.gov Identifier: NCT00846092|
Recruitment Status : Completed
First Posted : February 18, 2009
Last Update Posted : September 23, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Macular Edema||Device: Warp 10 LED Device Device: Near-infrared light (NIR)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
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 10
Device: Near-infrared light (NIR)
Other Name: Warp 10 LED's
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00846092
|United States, Wisconsin|
|Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator:||Harry T Whelan, MD||Medical College of Wisconsin|