A Phase 1 interventional study of Warp 10 LED Device and Near-infrared light (NIR) in Diabetic Macular Edema, sponsored by Medical College of Wisconsin. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-09-23.
Sponsored by Medical College of Wisconsin · Phase 1, Interventional, and Treatment
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
841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.
This study's enrollment of 4 is below the median of 50 across 619 interventional studies indexed under Macular Edema.
Browse Macular Edema studies →Medical College of Wisconsin is the lead sponsor of 540 studies on the registry; 120 are open to participants now.
Of its 71 completed or terminated interventional studies of FDA-regulated products, 56 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Diagnosis of diabetes mellitus (type 1 or type 2)
Exclusion Criteria:
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.
Major surgery within 28 days prior to participation or major surgery planned during the next 6 months.
* 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 · Device: Near-infrared light (NIR)
Study Subjects will take the Warp 10 (LED) home and treat twice per day for three months
Also known as: Warp 10
* 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.
Also known as: 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
This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
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Medical College of Wisconsin