Ongoing, recruitingPhase II and Phase III (Integrated)Interventional

A Phase 2/3 Double-masked, Randomized, 2-stage, Multicenter Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects With Diabetic Macular Edema

This research trial is investigating a new eye drop treatment for people who have diabetic macular edema (DME). DME is an eye condition linked to diabetes where swelling occurs in the macula, the part of your eye responsible for sharp, central vision. This swelling can lead to blurred vision or vision loss. The study aims to find out if these eye drops are effective and safe in helping to improve vision and reduce the swelling. Researchers will be looking closely at how much a person's vision improves over time, using a standard eye chart test. They will also measure changes in the swelling at the back of the eye. The study will last for about a year and involves two main stages of investigation, measuring vision changes at different points.

At a glance

Status

Ongoing, recruiting

Phase

Phase II and Phase III (Integrated)

Sponsor

Oculis Operations S.a.r.l.

Enrolment target

Start

21 Sep 2023

Diabetic Macular Edema (DME)

What is this study about?

This study is a clinical trial looking into a new eye drop treatment for a condition called diabetic macular edema, often shortened to DME. DME happens when high blood sugar from diabetes damages the tiny blood vessels in the retina, the light-sensitive layer at the back of your eye. These damaged vessels can leak fluid, causing swelling in a crucial part of the retina called the macula. The macula is vital for the clear, sharp vision you use for reading, recognising faces, and driving. This swelling can make your vision blurry or distorted, and if left untreated, it can lead to lasting vision loss.

The main goal of this research is to see how well these new eye drops work and whether they are safe to use for people with DME. Researchers are particularly interested in whether the eye drops can help improve a person's eyesight. They will measure this by using a special eye chart, similar to ones you might see at an optician, to check how many letters a participant can read. They will also be monitoring changes in the swelling at the back of the eye, as reducing this swelling is key to improving vision.

The trial is divided into two main stages, each looking at different time points to see how effective the treatment is. In the first stage, they'll check vision improvements six weeks into the study. In the second, longer stage, they'll look at the vision changes after a full year. This detailed approach helps researchers understand both the short-term and longer-term effects of the eye drops. Finding effective new treatments for DME is important because it can help preserve vision and improve the quality of life for many people living with diabetes.

Key takeaways

The study is testing new eye drops for diabetic macular edema (DME).
Its main aim is to see if the drops improve vision and reduce eye swelling.
Participation involves using eye drops and attending clinic visits for about a year.
You won't know if you're getting the active drops or a placebo.
This is a late-stage study (Phase 2/3) to confirm treatment effectiveness and safety.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 years or older.

Both men and women are welcome to take part in this research.

The study is specifically for individuals who have been diagnosed with diabetic macular edema (DME) and meet certain medical criteria, which the study team will discuss with 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.

Are you 18 years old or older?
Do you have a diagnosis of diabetic macular edema (DME)?
Are you able to attend regular clinic appointments for about a year?
Are you willing to use eye drops as instructed?
Are you comfortable with the possibility of receiving a placebo (dummy) treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will use specific eye drops. The study is "double-masked," which means neither you nor your study doctor will know if you are receiving the active treatment or a dummy (placebo) drop, to ensure fair results. You will have several clinic visits over a period of about a year (52 weeks). During these visits, the study team will carefully check your vision using eye charts and perform scans to measure the swelling at the back of your eye. They will also carry out other tests to monitor your eye health and overall well-being. Regular follow-up appointments are important to track any changes and ensure your safety throughout the study.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access a new potential treatment for your condition before it's widely available. While we hope the eye drops will be beneficial, there's no guarantee they will improve your vision or eye swelling, and they may have side effects. Potential risks will be fully explained by the study team before you decide to join. Remember, your participation is completely voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain
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Unverified
Hungary

Common questions

What is diabetic macular edema (DME)?

DME is an eye condition caused by diabetes, where fluid leaks into the macula, the central part of your retina, causing swelling and blurry vision.

What kind of treatment are they testing?

They are testing new eye drops that you put in your eye.

Will I know if I'm getting the real medicine?

No, neither you nor your doctor will know if you're getting the active eye drops or a non-active (placebo) eye drop. This is a standard practice in research to get unbiased results.

How long will the study last?

The study will last for about a year (52 weeks), with several visits to the clinic during that time.

What does a 'phase 2/3 study' mean?

It means the study is in a later stage of research. Phase 2 looks for the right dose and how well it works, while Phase 3 checks its effectiveness and safety in a larger group of people before it can be approved for general use.