Near-infrared Light (NIR) Therapy for Diabetic Macular Edema: A Pilot Study
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Ocular |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/2/2013 |
| Start Date: | November 2007 |
| End Date: | September 2012 |
| Contact: | Harry T Whelan, MD |
| Email: | hwhelan@mcw.edu |
| Phone: | 414-266-7544 |
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.
Inclusion Criteria:
1. 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.
2. 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)
3. At least one eye meets the study eye criteria.
4. Fellow eye meets criteria.
5. Able and willing to provide informed consent.
6. Any candidate identified by a study investigator as being able to successfully
tolerate a 3 month deferral of laser photocoagulation.
Exclusion Criteria:
7. Significant renal disease, defined as a history of chronic renal failure requiring
dialysis or kidney transplant.
8. 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.
9. 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...
10. 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.
11. Subject is expecting to move out of the area during the 6 months of the study.
We found this trial at
1
site
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
Click here to add this to my saved trials
