Active not recruitingPHASE2INTERVENTIONAL

A Study to Test Whether BI 764524 Helps People With an Eye Condition Called Diabetic Retinopathy

This study is for adults with a moderate to severe eye condition called diabetic retinopathy, which can happen if you have diabetes. Researchers want to know if a new medicine, BI 764524, can help improve this condition. They are also trying to find the best way to give this medicine. Participants will be split into different groups by chance. Some groups will receive BI 764524 injections, while others will get a sham (mock) treatment. In the US, one group will receive a commonly used medicine called aflibercept. The study lasts about one and a half years, involving regular eye checks. Doctors will closely monitor participants' eye health and general well-being throughout the study.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Boehringer Ingelheim

Enrolment target

190

Start

15 May 2024

Estimated completion

20 Aug 2027

Diabetic Retinopathy

What is this study about?

This study is looking into a new treatment called BI 764524 for an eye condition known as diabetic retinopathy. This condition affects people with diabetes and can cause vision problems. The main goal is to find out if BI 764524 can help improve the eyes of people with moderate to severe diabetic retinopathy. Researchers also want to figure out the best treatment plan for giving this medicine, for example, how often it should be injected.

To do this, participants will be put into different groups by chance. Some groups will receive injections of BI 764524 into one eye. Other groups will receive what's called a "sham control," which looks and feels like an eye injection but doesn't contain any medicine. This helps researchers compare the effects of the new medicine accurately. In the United States only, one group will receive aflibercept, which is a medicine already used to treat this eye condition.

Your involvement in this study would help doctors understand if BI 764524 could become a helpful new option for people living with diabetic retinopathy. By comparing different treatment approaches and monitoring eye health closely, the study aims to gather important information that could benefit many people in the future.

Key takeaways

This study evaluates a new treatment for diabetic retinopathy.
It's for adults with moderate to severe diabetic retinopathy.
Participation involves regular eye injections and clinic visits.
The study lasts about 18 months, with many check-ups.
Joining could contribute to future diabetic retinopathy treatments.

Who may be eligible?

This study is for adults aged 18 or older who have diabetes that's being managed. You would need to have a specific type of diabetic retinopathy, called moderate to severe non-proliferative diabetic retinopathy, in one of your eyes.

Your eye doctor would need to take special pictures of your eye to confirm your condition meets the study's requirements. Your vision in that eye also needs to be at a certain level. Generally, your eyes should be clear enough for doctors to take good quality pictures.

There are also some reasons why you might not be able to join. For example, if you have certain active or severe changes in the blood vessels at the back of your eye, you might not be eligible. Your study doctor will review all your health information to confirm if the study is right for you.

Quick self-check

Are you 18 years old or older?
Do you have diabetes that is being treated?
Has your doctor told you that you have moderate to severe non-proliferative diabetic retinopathy?
Is your vision in the affected eye generally quite good (e.g., 20/100 or better)?
Have you been told you don't have certain active severe eye vessel changes?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, it would last for about one and a half years. During this time, you would need to visit the study clinic at least 16 times. These visits are important for monitoring your eye health and general well-being.

During your appointments, you would have regular eye exams and vision tests. These tests help the doctors see how your eye condition is changing. Depending on which group you are in, you would receive either injections of BI 764524, a sham (mock) injection, or in the US only, aflibercept, into one eye. The number of injections would depend on your assigned group.

Doctors will also regularly check your overall health and record any new or unexpected effects you might experience. After one year of treatment, researchers will carefully compare the eye health and any improvements among the different groups to understand how effective the new medicine is.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of joining this study is that you might receive access to a new treatment that could improve your diabetic retinopathy. You will also receive regular and thorough eye examinations. However, there's no guarantee the treatment will work for you, and it's possible you could experience side effects from the injections or the medicine. The research team will explain all known risks to you. Remember, participating is completely voluntary, and you can change your mind and leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (89)

Associated Retina Consultants, Ltd.
Phoenix, United States
California Retina Consultants-Bakersfield-65523
Bakersfield, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, United States
Retinal Diagnostic Center
Campbell, United States
The Retina Partners
Encino, United States
Lugene Eye Institute
Glendale, United States
Retina Associates of Southern California
Huntington Beach, United States
Byers Eye Institute
Palo Alto, United States
California Eye Specialists Medical Group Inc
Pasadena, United States
Retinal Consultants Medical Group
Sacramento, United States
Retinal Consultants Medical Group
Sacramento, United States
California Retina Consultants-Santa Maria-65510
Santa Maria, United States

+77 more sites — see the official record for the full list.

Common questions

What is diabetic retinopathy?

It's an eye condition that can affect people with diabetes, where high blood sugar levels damage the blood vessels in the back of the eye, potentially leading to vision loss.

What is BI 764524?

It's a new medicine being tested to see if it can help improve the eye condition called diabetic retinopathy.

What is a 'sham control'?

A sham control is like a mock eye injection. It's done to make sure participants don't know if they're getting the actual medicine or not, so we can fairly compare results.

How long will I be in the study?

The study lasts for about one and a half years (18 months).

Will I have to travel for the study?

Yes, you would need to visit the study clinic at least 16 times over the 18 months.