Purpose of study:
This research study is being done to compare two different injection treatments for diabetic macular edema. We want to find out if starting treatment for diabetic macular edema with a drug called Eylea has better results than starting with the less expensive drug, Avastin, and only switching to Eylea if needed.
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 2 years with visits every 4 weeks during the first year and visits every 4-16 weeks during the second year depending on treatment needs. Study visits will take about 1.5-2 hours depending on what procedures are done that day.
You have an equal chance of being placed into either the Eylea or Avastin treatment group to start. The frequency and type of injection you receive after that will depend on how well your eye responds to treatment. You will not be told what treatment you are getting as part of the study.
Study visits consist of a few imaging tests, vision testing, blood pressure measurement, Hemoglobin A1c testing, and an eye exam.
Research volunteers will be compensated $25 for the completion of each study visit.
You may be eligible to participate in this study if you meet these criteria:
1. You are 18 years or older.
2. You have been told by a doctor that you have diabetes mellitus (type 1 or type 2).
3. You have been told by a doctor that you have diabetic macular edema (DME).
4. You have not had treatments for DME recently.
5. You are not on kidney dialysis.
Jaeb IRB application 2018-33272, 8/6/2018