GR43828 (Intravitreal Injections for Diabetic Macular Edema) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find out if an investigational drug called RO7446603 (the study drug) is a safe treatment for diabetic macular edema. We will give the drug at different doses and also want to understand the way the body processes the drug.
Diabetic Macular Edema
Who Can Participate in the Study?
Adults ages 18+ who:
- Are diagnosed with diabetic macular edema
- Are diagnosed with diabetes mellitus (Type 1 or Type 2)
- Take medication to treat diabetes
For more information about who can be in this study, please contact the study team at DEC-RA@duke.edu.
What is Involved?
If you choose to join the study, you will get a single injection of a drug called faricimab into the eye. We will schedule you to come back to our clinic 4 weeks later to see how you reacted to the dose of faricimab. You will be eligible to continue in the study based on how you react to the injection of faricimab. We think about 60% of people who join the study will be eligible to continue and about 40% will not be eligible.
If you are not eligible to continue, your participation will end. If you are eligible to continue, you will get a random assignment (like a coin flip) to 1 of 2 groups:
- One group will get 2 injections of the study drug into the eye 8 weeks apart, along with 3 injections of faricimab 4 weeks apart. The first and third injections of faricimab will be at the same visit as the injections of the study drug.
- The other group will get 3 injections of faricimab 4 weeks apart and will not get the study drug
You will be in touch with the study team for about 9 months altogether and visit our clinic at the Duke Eye Center up to 14 times.
At various visits, you will have blood tests, eye exams, and vision tests.