Near-infrared Light (NIR) Therapy for Diabetic Macular Edema: A Pilot Study

Inclusion criteria

• 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.
• 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)
• At least one eye meets the study eye criteria.
• Fellow eye meets criteria.
• Able and willing to provide informed consent.
• Any candidate identified by a study investigator as being able to successfully tolerate a 3 month deferral of laser photocoagulation.

Exclusion criteria

• Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
• 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.
• 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...
• 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.
• Subject is expecting to move out of the area during the 6 months of the study.