Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on the Effectiveness and Safety of OCS-01 Eye Drops with Dexamethasone for Patients with Diabetic Macular Edema

Verified siteInvestigational
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Diabetic Macular Edema (DME), a condition that affects the eyes of people with diabetes, leading to vision problems. The study will test the effectiveness and safety of a new treatment called OCS-01, which is an eye drop containing the active ingredient dexamethasone. Dexamethasone is a type of medication known as a corticosteroid, which is used to reduce inflammation and swelling.

The purpose of the study is to compare the effects of OCS-01 with a placebo over a period of 52 weeks. Participants will be randomly assigned to receive either the OCS-01 eye drops or a placebo. Throughout the study, participants will have regular check-ups to monitor their eye health and overall well-being. The main goal is to see if there is an improvement in vision, specifically looking at changes in the ability to see clearly, which is measured by a test called Best Corrected Visual Acuity (BCVA).

Participants will also be monitored for any side effects or changes in their eye condition. The study aims to provide valuable information on whether OCS-01 can be a safe and effective treatment option for people with Diabetic Macular Edema. This research could potentially lead to better management of this eye condition, improving the quality of life for those affected by it.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will have signed an informed consent form. This confirms understanding of the study and agreement to participate.

    Eligibility is confirmed based on specific criteria, including age, medical history, and current health status related to Diabetic Macular Edema (DME).

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish baseline measurements. This includes checking Best Corrected Visual Acuity (BCVA) and central subfield thickness (CST) using specific eye tests.

    Participants must have a documented diagnosis of diabetes and meet certain health criteria, such as HbA1c levels.

  3. Step 3

    Treatment phase

    Participants receive OCS-01 eye drops, which are a suspension for ocular use. The dosage and frequency are determined by the study protocol.

    The treatment aims to evaluate the efficacy and safety of the eye drops over a period of 52 weeks.

  4. Step 4

    Regular follow-up visits

    Regular follow-up visits are scheduled to monitor progress and any changes in vision. These visits include assessments of BCVA and CST.

    Safety is monitored through various tests, including intraocular pressure, blood tests, and other health checks.

  5. Step 5

    Final assessment

    At the end of the 52-week period, a final assessment is conducted to measure changes in vision and overall eye health.

    The primary goal is to determine the mean change in BCVA from the start of the study to the end.

Who can join the trial?

11 criteria

  • You must sign a form agreeing to participate before any study-related procedures are done.
  • You need to be an adult, either male or female, aged between 18 and 85 years.
  • You should have **Diabetic Macular Edema (DME)**, which means there is fluid in the layers of the retina in your eye, with a **Central Subfield Thickness (CST)** of at least 310 micrometers, as measured by a special eye scan called **SD-OCT**.
  • Your vision in the eye not being studied should be better than 20/200, which is a way to measure how well you see.
  • Your vision in the eye being studied should be between 20/50 and 20/320, which are measurements of visual clarity.
  • You must have been diagnosed with either **Type 1 or Type 2 diabetes** and have a blood test result called **HbA1c** that is 10.0% or lower.
  • You should not have received certain treatments for your eye condition before, or if you have, enough time should have passed since your last treatment. This includes:
    • No treatment with **anti-VEGF** or **corticosteroid** injections in the eye before, or if treated, a waiting period of:
      • 3 months for anti-VEGF injections
      • 4 months for **Triamcinolone** injections
      • 6 months for a slow-release steroid implant like **Ozurdex**
      • 3 years for nonbiodegradable steroid implants like **Iluvien**, **Retisert**, or **Yutiq**
      • If you are a woman who can become pregnant, you must have a negative pregnancy test at the start and use effective birth control during the study.

Who cannot join the trial?

8 criteria

  • Patients who have any other eye disease that could affect the study results.
  • Patients who have had eye surgery in the last 3 months.
  • Patients who are currently using other treatments for Diabetic Macular Edema (DME).
  • Patients with uncontrolled diabetes, meaning their blood sugar levels are not stable.
  • Patients who have a history of severe allergic reactions.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial in the last 30 days.
  • Patients with any serious health condition that could interfere with the study.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

OCS-01 Eye Drops are being studied for their effectiveness and safety in treating Diabetic Macular Edema, a condition that affects the retina in people with diabetes. The trial aims to determine how well these eye drops work in reducing the swelling and improving vision over a period of 52 weeks.

What is already known about the treatment

OCS-01 – OCS-01 is an investigational eye drop formulation currently being studied in a Phase 3 clinical trial for its effectiveness and safety in treating Diabetic Macular Edema (DME). This medication is administered directly to the eye, providing a targeted approach to managing this condition. The main therapeutic indication for OCS-01 is to reduce swelling in the retina caused by diabetes, which can lead to vision impairment. At the molecular level, OCS-01 is believed to work by inhibiting inflammatory pathways that contribute to fluid accumulation in the retina. It is classified pharmacologically as an anti-inflammatory agent.

Investigated diseases

Diabetic Macular Edema – Diabetic Macular Edema (DME) is a condition that affects the eyes, specifically the macula, which is the part of the retina responsible for sharp, central vision. It occurs when blood vessels in the retina become damaged due to high blood sugar levels, leading to fluid leakage and swelling in the macula. This swelling can cause vision to become blurry or wavy, and colors may appear washed out. Over time, if left unchecked, the condition can lead to more significant vision impairment. DME is commonly associated with diabetes and is a complication of diabetic retinopathy. The progression of the disease can vary, with some individuals experiencing gradual changes in vision, while others may notice more rapid deterioration.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507207-66-00Protocol codeDX221Estimated enrolment348 patientsSponsorOculis Operations SARL

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.