How Does Semaglutide Affect Your Eye Health?
Learn about a clinical trial designed to study the long-term effects of the GLP-1 receptor agonist semaglutide on eye health and how to enroll if you are eligible.
Clinical Trials Identifier: NCT03811561
Trial Name: A Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes (FOCUS)
Diabetes type: Adults with type 2 diabetes
Trial Sponsor: Novo Nordisk
Why does this trial matter?
The GLP-1 receptor agonist semaglutide (known by the brand names: Wegovy, Ozempic, and Rybelsus), has been shown to have several benefits for people with type 2 diabetes. It helps people lower their glucose levels, better manage their weight, and it has been shown to protect against diabetes-related complications such as heart disease.
However, very few studies have evaluated the impact of GLP-1 receptor agonists on eye health. People with diabetes are at a much greater risk for experiencing eye-related complications. High glucose levels can damage the blood vessels all over the body, including in the eyes. As a result, people with diabetes are especially at risk for the four types of eye diseases collectively called diabetic eye disease: diabetes-related retinopathy, diabetes-related macular edema, cataracts, and glaucoma. To learn more about these complications, read, “Seeking Healthy Vision: Eight Strategies For Caring for Eyes.”
While there are already some treatments for these complications, this study will hopefully be able to shed light on how GLP-1 receptor agonists specifically affect the eye health of people with diabetes long-term.
This trial comes after other studies, notably LEADER (looking at liraglutide) and SUSTAIN-6 (looking at semaglutide) showed slightly elevated levels of new onset or worsening diabetic retinopathy. Researchers want to uncover if GLP-1 receptor agonists may worsen people’s eye health, or if these resulted from these other studies’ limitations.
Read our series on caring for your eyes to learn more about maintaining healthy vision.
What is the trial testing?
This study will enroll 1500 participants with type 2 diabetes to study the long term effects of semaglutide (a GLP-1 receptor agonist) on diabetic eye disease. Diabetic eye disease is a group of eye conditions that can sometimes affect people with diabetes. It includes diabetic retinopathy, diabetic macular edema, cataracts, and glaucoma.
Participants will be randomly assigned to receive either semaglutide or a placebo drug as a once-weekly injection for up to five years. This will be in addition to their other diabetes medications.
Researchers are measuring whether participants experience the progression of diabetic retinopathy. In addition, they will be measuring eye function (how clear and sharp vision is), whether people require treatment for diabetic retinopathy or diabetic macular edema, and changes in A1C, body weight, blood pressure, and cholesterol.
Trial length: Five years
Trial locations: This is a multicenter, worldwide study with over 100 locations across the United States, Brazil, Canada, Germany, India, Israel, the United Kingdom, and several other countries. You can see a list of all participating locations here.
Are you interested?
You may be eligible to participate in this study if you:
- Are an adult with type 2 diabetes.
- Have an A1C between 7% and 10 %.
- Meet a number of eye inclusion criteria including not being treated diabetic retinopathy or diabetic macular edema. Learn more about this specific criteria here.
- Are not pregnant or breastfeeding.
- Have not have a heart attack or stroke within the past 60 days
- Have an eGFR greater than 30 ml/min/1.73 m2
You can see a full list of inclusion/exclusion criteria here.
For more information: To learn more, you can contact the Novo Nordisk study team at email@example.com or call (+1) 866-867-7178.