RecruitingPHASE3INTERVENTIONAL

CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME

This research study, called CAPRI, is looking into a new treatment called EYP-1901 for a common eye condition called diabetic macular edema (DME). DME happens when diabetes damages tiny blood vessels in the eye, causing fluid to leak and blur vision. The study wants to compare how well EYP-1901 works against a standard treatment, Aflibercept. Researchers will randomly assign participants to receive one of these treatments, and neither the patient nor the doctor will know which one, to ensure fair results. The main goal is to find out if EYP-1901 is as effective as Aflibercept in helping to maintain or improve eyesight in people with DME.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

EyePoint Pharmaceuticals, Inc.

Enrolment target

240

Start

09 Feb 2026

Estimated completion

01 Oct 2028

Diabetic Macular Edema DME Diabetic Macular Edema (DME)

What is this study about?

Diabetic macular edema (DME) is an eye condition that can affect people with diabetes. It happens when high blood sugar levels damage the tiny blood vessels in the retina, the light-sensitive tissue at the back of your eye. This damage can cause fluid to leak into an area called the macula, which is responsible for your sharp central vision. When the macula swells, it can lead to blurred vision or even vision loss if not treated.

Currently, there are treatments like anti-VEGF injections (one of which is Aflibercept) that help to reduce swelling and improve vision by blocking a protein that causes blood vessels to leak. This study is testing a new treatment, EYP-1901, to see if it can be another effective option for people living with DME. Researchers are keen to find out if EYP-1901 works as well as Aflibercept.

Taking part in this study could help doctors understand more about treating DME, potentially leading to new or improved ways to maintain vision for people with diabetes. Your participation could contribute important information that benefits many people in the future.

Key takeaways

This study is comparing a new eye treatment (EYP-1901) with a current one (Aflibercept) for diabetic macular edema (DME).
It's a 'double-masked' study, meaning neither you nor your doctor will know which treatment you receive.
Participation involves regular clinic visits for eye checks and treatments.
You must have a diagnosis of DME in at least one eye and be over 18.
You can stop participating at any time without affecting your normal care.

Who may be eligible?

To be able to join this study, you would generally need to have been diagnosed with diabetic macular edema (DME) in at least one eye. Your vision in the study eye, when measured, should be within a certain range – not too poor, and not perfect. You also need to be at least 18 years old.

If you've had treatment for DME before, you must have had at least one anti-VEGF injection in the last year, and your most recent injection must have been at least 12 weeks before you'd start this study. This helps ensure that the effects of previous treatments don't interfere with the study results.

There are also some reasons why you might not be able to join. For example, if the vision in your other eye (the 'fellow eye') is very poor, you might not be suitable for this study. The research team will carefully check all these details to make sure the study is safe and right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am at least 18 years old.
I have been diagnosed with diabetic macular edema (DME) in at least one eye.
My vision in the affected eye is within a specific range the doctors are looking for.
If I've had anti-VEGF eye injections before, my last one was at least 12 weeks ago.

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly assigned to receive either the new treatment (EYP-1901) or the standard treatment (Aflibercept). This means it's like flipping a coin – you won't get to choose which one you receive. Neither you nor your study doctor will know which treatment you are getting; this is called 'double-masked' and helps make sure the study results are as fair as possible.

Throughout the study, you would have regular visits to the clinic. These visits will involve various eye tests and examinations to check your vision and the health of your eye, as well as general health checks. You will receive your assigned eye treatment at scheduled intervals. The total duration of your participation in the study, including all treatments and follow-up appointments, will be explained in detail by the study team.

Potential risks and benefits

Participating in this study might offer you some potential benefits, such as receiving close medical attention and access to a new treatment that might improve or stabilize your vision. However, there are also potential risks involved, similar to any medical treatment or research study. These could include side effects from the eye treatments, discomfort during clinic visits, or that the treatment might not work for you. All possible risks will be fully explained before you agree to take part. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (62)

Associated Retina Consultans
Verified postcode
Gilbert, United States· Recruiting
Associated Retina Consultants - Phoenix
Verified postcode
Phoenix, United States· Recruiting
Phoenix Retina Clinical Trials, LLC - North Phoenix
Verified postcode
Phoenix, United States· Recruiting
Retina Macula Institute of Arizona
Verified postcode
Scottsdale, United States· Recruiting
Retina Vitreous Associates Medical Group
Verified postcode
Beverly Hills, United States· Recruiting
Retina Consultants of Orange County
Verified postcode
Fullerton, United States· Recruiting
South Coast Retina Center
Verified postcode
Long Beach, United States· Recruiting
Retinal Consultants Medical Group - Modesto
Verified postcode
Modesto, United States· Recruiting
Kaiser Permanente
Verified postcode
Oakland, United States· Recruiting
Retina Consultants of Southern California
Verified postcode
Redlands, United States· Recruiting
Bay Area Retina Associates
Verified postcode
Walnut Creek, United States· Recruiting
Retina Specialists of Colorado - Arvada
Verified postcode
Arvada, United States· Recruiting

Common questions

What is diabetic macular edema (DME)?

DME is an eye condition where diabetes causes fluid to leak into the macula, part of your eye responsible for sharp central vision, leading to blurry vision.

What is the new treatment being tested?

The new treatment is called EYP-1901, and it's being compared to a standard treatment called Aflibercept for DME.

Will I know which treatment I'm receiving?

No, both you and your doctor will not know if you're getting EYP-1901 or Aflibercept. This is done to ensure the study results are fair.

How long will the study last?

The study team will give you a detailed timeline at your first visit, outlining the total duration of your involvement, including all treatments and follow-up.

Can I leave the study if I change my mind?

Yes, you can choose to withdraw from the study at any point, and it won't affect your future medical care.

How to find out more

Ramiro Ribeiro, MD, PhD

rribeiro@eyepoint.bio 833-393-7646 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.