Currently Enrolling Study
Diabetic Retinopathy Clinical Research Network - Protocol AE
Purpose of study:
This research study is being done to see if wearing a device that shines a light over your closed eye for 90 seconds twice a day can help treat diabetic macular edema.
What is diabetic macular edema?
Diabetic macular edema (DME) is a condition that affects central vision. DME is characterized by swelling in the center of the retina (the light-sensitive lining inside the back of the eye) from diabetes. This swelling causes damage to light-sensitive retinal cells resulting in decreased vision.
What is involved?
The study will last 8 months with visits every 4 weeks for the first half and every 8 weeks in the second half. Study visits will take about 1.5-2 hours depending on what procedures are done that day. Study visits may include vision testing, imaging of your eyes, blood pressure measurement, HbA1c testing, and an eye exam.
As part of the study you will have to wear a device that shines a light over your closed eye for ninety seconds at a time. You will have to wear this device twice a day every day you are in the study. When you start the study, you will be assigned randomly to either an "active light" treatment or an "inactive light" treatment. The "active light" treatment is being tested to see if it can help treat DME. The "inactive light" is not believed to have any effect on your vision, and will be used as a comparison. Halfway through the study, your treatment will be switched. There is an equal chance of being assigned to either group. You will not be told what treatment you are getting as part of the study.
Research volunteers will receive $50 for the completion of each study visit.
You may be eligible to participate in this study if you meet these criteria.
- You are 18 years or older.
- You have been told by a doctor that you have diabetic macular edema (DME) with good vision.
- You have not received certain other treatments in your eye in the past.
- You are not on kidney dialysis.
- You are able and willing to wear the light device twice a day for 8 months.
Contact Ellie Dorsey Veh with questions. (414) 955-7854 or email
JCHR IRB approved May 31, 2019
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