Diabetic Macular Edema Clinical Trial
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.
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
1. 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.
2. To assess safety of short term near-infrared light therapy in eyes with diabetic
macular edema.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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