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

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What is this trial about?

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

This clinical trial is focused on studying a condition called Diabetic Macular Edema (DME), which affects the eyes of people with diabetes. The study is testing a new treatment in the form of eye drops known as OCS-01, which contain the active ingredient dexamethasone. Dexamethasone is a type of medication that helps reduce inflammation and swelling. The purpose of the study is to evaluate how effective and safe these eye drops are for people with DME.

The study is divided into two stages. In the first stage, researchers will determine the best dosing schedule for the eye drops. In the second stage, they will compare the effects of the eye drops to a placebo over a period of 52 weeks. Participants will be randomly assigned to receive either the OCS-01 eye drops or a placebo, and neither the participants nor the researchers will know which treatment each participant is receiving. This is known as a "double-masked" study, which helps ensure that the results are unbiased.

Throughout the study, participants will have regular check-ups to monitor their eye health and vision. The main focus will be on changes in vision clarity, measured by a test called Best Corrected Visual Acuity (BCVA). This test helps determine how well a person can see with the best possible glasses or contact lenses. The study aims to see if the OCS-01 eye drops can improve vision in people with DME compared to those who receive a placebo. Participants will also be monitored for any side effects or safety concerns related to the treatment.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the participant will be required to sign an informed consent form. This is a necessary step before any study-specific procedures can be performed.
Step 2
Initial assessment
Participants will undergo an initial assessment to confirm eligibility. This includes checking visual acuity and confirming a diagnosis of diabetic macular edema (DME).
Step 3
Stage 1: Treatment initiation
Participants will begin treatment with OCS-01 eye drops, which are a suspension for ocular use. The specific dosing regimen will be determined during this stage.
The primary goal is to select the appropriate dosing regimen for the eye drops in participants with DME.
Step 4
Stage 1: Monitoring and evaluation
Participants will be monitored for changes in visual acuity using the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score. This will occur at Visit 5 (Week 6) and Visit 7 (Week 12).
The study will assess the proportion of participants with significant improvements in visual acuity and changes in central subfield thickness (CST) of the retina.
Step 5
Stage 2: Long-term evaluation
Participants will continue to use the OCS-01 eye drops or a vehicle for up to 52 weeks. The efficacy and safety of the treatment will be evaluated at Visit 12 (Week 52).
The study will measure changes in visual acuity and CST over the course of the year.
Step 6
Completion of the study
The study is expected to conclude by January 19, 2026. Participants will have their final assessments to determine the overall effectiveness and safety of the treatment.

Who can join the trial?

8 criteria

Must have signed an informed consent form before any study-specific procedures are performed. This means you agree to participate and understand what the study involves.
Must be a male or female adult aged 18 to 85 years.
Must have a condition called **Diabetic Macular Edema (DME)**, which involves fluid in the eye, with a certain thickness measured by a special eye scan called **Spectral Domain Optical Coherence Tomography (SD-OCT)**.
Must have a certain level of vision in the eye being studied, measured by a test called **Best Corrected Visual Acuity (BCVA)**. This test checks how well you can see letters on a chart.
Must have a documented diagnosis of **Type 1 or Type 2 diabetes mellitus** and a blood test result called **HbA1c** that is 12.0% or lower. This test shows your average blood sugar levels over the past few months.
If you have been treated with certain eye medications in the past, you must wait a specific amount of time before starting the study. These medications include **anti-VEGF agents** and **corticosteroids**, which are used to treat eye conditions.
If you have never received treatment with anti-VEGF agents or corticosteroids in the eye being studied, you can still participate.
If you are a woman who can become pregnant, you must have a negative pregnancy test 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 three months.
Patients who are currently using other treatments for diabetic macular edema.
Patients with uncontrolled diabetes, meaning their blood sugar levels are not stable.
Patients who have a history of severe allergic reactions to any of the study medications.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial within the last 30 days.
Patients with any serious health condition that the study doctor thinks could interfere with the study.

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Verified sites

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

Hospital Clinico San Carlos
Verified
Madrid, Spain
Hospital Universitario De Navarra
Verified
Pamplona, Spain
Semmelweis University
Responsive
Budapest, Hungary

Trial locations

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Investigated drugs

OCS-01 Eye Drops are being studied for their effectiveness and safety in treating diabetic macular edema, a condition that affects the eyes of people with diabetes. The trial aims to determine the best dosing regimen and to compare the results of using these eye drops against a non-active treatment over a period of 52 weeks.

Dexamethasone

What is already known about the treatment

OCS-01 – OCS-01 is an eye drop medication currently being studied in clinical trials for its effectiveness in treating Diabetic Macular Edema (DME). It is administered directly to the eye, providing a targeted approach to managing this condition. The medication is in the Phase 2/3 stage of clinical trials, where its safety and efficacy are being evaluated. OCS-01 works by reducing inflammation and fluid accumulation in the retina, which are key factors in DME. It belongs to the pharmacological class of anti-inflammatory agents, specifically designed for ocular use.

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 blurred or distorted vision, making it difficult to read, drive, or see faces clearly. Over time, if left untreated, the condition can lead to more severe vision impairment. DME is commonly associated with diabetes and is a complication of diabetic retinopathy. The progression of DME can vary, with some individuals experiencing gradual changes in vision, while others may notice more rapid deterioration.