Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

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

This research study is investigating the effectiveness and safety of a new eye drop treatment for people with diabetic macular oedema (DMO). DMO is an eye condition linked to diabetes that can affect your central vision. The study aims to find out if these eye drops can improve your eyesight over a period of 52 weeks (about a year). Researchers will be carefully checking vision changes and also looking at how safe the drops are by monitoring for any side effects. Both men and women aged 18 and above who have DMO might be able to take part in this study.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Oculis Operations S.a.r.l.

Enrolment target

133

Start

20 May 2024

Diabetic Macular Edema (DME)

What is this study about?

This study is looking into a new eye drop treatment for a condition called diabetic macular oedema, or DMO. DMO can happen to people who have diabetes and it affects the macula, which is the central and most important part of the retina at the back of your eye. When the blood vessels in the retina leak fluid, it causes swelling in the macula, which can make your vision blurry or distorted.

The main goal of this particular study is to see if these new eye drops can improve your eyesight over time. They will measure this by looking at how many letters you can read on an eye chart, similar to the one you might see at an optician. This will be checked at the start of the study and again after about a year (52 weeks).

Beyond just seeing if vision improves, the researchers will also be very keen to understand how safe these eye drops are. They will carefully monitor for any side effects or changes in other health measurements. This is a "Phase 3" study, which means it's one of the final stages of testing before a new medicine might be considered for wider use.

Key takeaways

This study is testing new eye drops for diabetic macular oedema (DMO).
Its main aim is to see if the drops can improve eyesight and if they are safe.
The study will last about one year (52 weeks) with regular clinic visits.
Participants must be 18 years or older and have a diagnosis of DMO.
You will be closely monitored for both vision changes and any side effects.

Who may be eligible?

To be able to take part in this study, you need to be an adult, aged 18 years or older. Both men and women are welcome to participate.

The main requirement is that you have diabetic macular oedema (DMO). The study team will need to confirm your diagnosis and make sure it fits with the study's specific criteria.

There will also be other medical checks to make sure the study is a good fit for you and that it would be safe for you to take part. This usually involves reviewing your medical history and current health.

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 diabetic macular oedema (DMO)?
Are you willing and able to attend regular clinic visits for about one year?
Are you comfortable with the possibility of receiving either the study drug or a placebo?
Do you understand that there will be various eye checks and general health assessments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would use eye drops as instructed by the study team. You would also have several visits to the clinic over a period of about 1 year (52 weeks). At these visits, doctors and nurses would perform various assessments. This includes regular eye tests, like reading an eye chart, to check your vision. They would also take special pictures of your eye to measure the swelling.

Throughout the study, your general health would be monitored closely. This might involve blood tests, checking your blood pressure, and asking about any changes in your health or any side effects you might experience. The study team will explain everything in detail, including how often you need to come in and what each visit will involve.

Potential risks and benefits

Taking part in a study like this could potentially offer benefits, such as access to a new treatment before it's widely available and closer monitoring of your eye condition and general health. However, there are also potential risks, including side effects from the eye drops, which might be unknown at this stage, or the treatment not working for you. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

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

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Unverified
Italy
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Unverified
France
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Unverified
Germany
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Unverified
Spain
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Unverified
Czechia
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Unverified
Bulgaria

Common questions

What is diabetic macular oedema (DMO)?

DMO is an eye condition common in people with diabetes. It happens when fluid leaks into the macula, the central part of your retina, causing blurry or distorted vision.

What kind of treatment are the eye drops?

The study is testing a new type of eye drop treatment. It's given as a liquid suspension that you put directly into your eye.

How long will I be in the study?

The main part of the study where your vision changes are assessed will last for about 52 weeks, which is approximately one year.

What does 'double-masked' mean in the study title?

It means neither you nor the study doctors will know if you're receiving the actual study drops or a placebo (a dummy drop). This helps make the study results fair and unbiased.

Will I have to pay for the eye drops or visits?

Typically, all study-related treatments and visits in clinical trials are provided at no cost to the participant, but you should always confirm this with the study site.