Status:
COMPLETED
Near-infrared Light (NIR) Therapy for Diabetic Macular Edema: A Pilot Study
Lead Sponsor:
Medical College of Wisconsin
Collaborating Sponsors:
The New York Eye & Ear Infirmary
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 aug...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00846092
Start Date
November 1 2007
End Date
February 1 2013
Last Update
September 23 2013
Active Locations (1)
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1
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226