Diabetic Retinopathy Clinical Trials

Diabetic retinopathy (DR) is a complication of diabetes that affects the retinas in the eyes.1 There are a few available treatments approved by the U.S. Food and Drug Administration (FDA), but researchers and doctors continue to look for new therapies or effective ways to use drugs approved for treating other diseases for diabetic retinopathy.

For these treatments to be approved, they must first go through clinical trials. These are studies that last several months to years and use healthy volunteers as well as those with DR to determine whether a drug or procedure is safe and effective.

The drugs and diagnostic tools discussed below are just some of the current diabetic retinopathy clinical trials.

New Medications for Diabetic Retinopathy

One clinical trial is investigating the drug runcaciguat, which is also being studied for treating chronic kidney disease.2 A phase 2 clinical trial is recruiting patients with moderately severe to severe non-proliferative DR (in which no new blood vessels or scarring has formed).3

Another trial is studying the investigative drug OTT166. While most diabetic retinopathy drugs are injected into the eye, OTT166 is a medicated eye drop. A phase 2 clinical trial is currently recruiting people with several types of diabetic retinopathy, including moderately severe to severe non-proliferative DR or mild proliferative DR (in which new blood vessels and scarring have formed).4

Previously Approved Medications for Diabetic Retinopathy

Sometimes, researchers find that drugs already approved by the FDA for treating one condition may be useful for treating others. These medications must undergo clinical trials in the other conditions to be approved and advertised for the appropriate uses.

Sinemet® CR (carbidopa-levodopa extended release) is a medication used to treat Parkinson’s disease. It works by increasing levels of the chemical messenger dopamine. Interestingly, dopamine levels decrease in the retina in DR, so investigators are looking into the effects of treating early-stage DR with Sinemet® CR. The phase 1 study is enrolling by invitation only.5

Another trial is studying whether brolucizumab (Beovu®) is more effective than photocoagulation laser therapy for treating proliferative DR. Brolucizumab is already FDA-approved for treating age-related macular degeneration, an eye condition that makes it difficult to see straight ahead, drive, or read. A phase 3 clinical trial is currently recruiting patients.6

Medical and Diagnostic Procedures for Diabetic Retinopathy

When people think of clinical trials, they mainly think of studies testing new drugs. However, medical and diagnostic procedures must also go through clinical trials to ensure that they work well or are accurate.

There are currently several clinical trials looking into different diagnostic methods for DR. One is a study investigating the use of artificial intelligence (AI) for detecting early cases of DR. People with diabetes are invited to participate. The trial involves getting pictures of your retina taken with an FDA-approved camera in your doctor’s office. An AI software then reads the pictures to look for signs of DR.7

Enrolling in Diabetic Retinopathy Clinical Trials

Find Clinical Trials Near Me

Interested in clinical trials? Simply search by postal code and type of condition to see what’s going on in your area.


Before you can join a DR clinical trial, you should consider the time commitment and benefits of a clinical trial. Some people join trials to help advance research and science, while others join in the hope of finding new treatments that work for them. No matter your reasons, joining a clinical trial should be the best choice for you.

Eligibility for Diabetic Retinopathy Clinical Trials

To join a clinical trial, you must meet the study’s eligibility criteria. This is a set of inclusion and exclusion criteria that study investigators use to determine who can and can’t participate in a trial.

Inclusion criteria are requirements you must meet to join a study. Examples from some DR trials include:4,7

  • Adult male and female subjects who are at least 18 years old with type 1 or type 2 diabetes
  • Have an HbA1c level of 6.5 or higher or a fasting blood sugar level of 126 mg/dL or higher
  • Have a specific type of DR

Exclusion criteria are characteristics that make you ineligible to participate in a study. Examples of exclusion criteria in some diabetic retinopathy clinical trials include:3,6,7

  • History of eye surgery
  • Presence of fluid in the eye (macular edema)
  • Previous treatment with anti-vascular endothelial growth factor (VEGF) therapies