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 study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy
Centre Hospitalier Intercommunal Creteil Creteil France
University Medicine Greifswald Greifswald Germany
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Centre Hospitalier Universitaire De Bordeaux Bordeaux France

Other Sites

Site Name City Country Status
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Clinico Universitario De Valladolid Valladolid Spain
MBAL Trakia EOOD Stara Zagora Bulgaria
Medical Center Vereya EOOD Stara Zagora Bulgaria
Specialized Eye Hospital For Active Treatment Pentagram ЕООD Sofia Bulgaria
Oftex s.r.o. Pardubice Czechia
Theorie Etudes Organisation Recherche En Retine Medicale S.A.R.L. Paris France
Centre Monticelli Paradis D Ophtalmologie Marseille France
Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia Rome Italy
Oftalmologia Vistahermosa S.L. Burjassot Spain
Fakultni Nemocnice Plzen Plzen Czechia
Specialized Hospital for Active Treatment of Oncology Diseases Prof. d-r Marin Mushmov EOOD Sofia Bulgaria
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Ospedale San Raffaele S.r.l. Milan Italy
Saarland University Hospital Homburg Germany
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
IRCCS Ospedale Policlinico San Martino Genoa Italy
Justus-Liebig-Universitaet Giessen Giessen Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Instituto Clinico Quirúrgico de Oftalmología. ICQO Bilbao Spain
Azma Cqqdchwr svwmes Prague Czechia
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Ijozvn Osgjnl Ish Bmbzpdsxx Barcelona Spain
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Cwvfit Hwvuipwufkm Uebnzposoxwlq Dc Dnkew Dijon France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
20.05.2024
Czechia Czechia
Not recruiting
20.05.2024
France France
Not recruiting
20.05.2024
Germany Germany
Not recruiting
20.05.2024
Italy Italy
Not recruiting
20.05.2024
Spain Spain
Not recruiting
20.05.2024

Trial locations

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.

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 ID:
2023-507207-66-00
Protocol code:
DX221
Trial Phase:
Therapeutic confirmatory (Phase III)

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