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
Centre Hospitalier Intercommunal Creteil Creteil France
Azienda Ospedaliero Universitaria Careggi Florence Italy
University Medicine Greifswald Greifswald Germany
Centre Hospitalier Universitaire De Bordeaux Bordeaux France

Other Sites

Site Name City Country Status
Ospedale San Raffaele S.r.l. Milan Italy
Hopital Beaujon Clichy France
Hospital Clinico Universitario De Valladolid Valladolid Spain
Saarland University Hospital Homburg Germany
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Ffemdnqt Npsqdvhqw Krmlorbuq Vhkvidqyr Prague Czechia
Ivkff Ovkpifam Ptoeghqcydd Sex Myvekeb Genoa Italy
Uofkfuijfestxgfqqnymf Hgobnzrevx Aak Heidelberg Germany
Jcwonzsxdeikqiaymqwiaicfxe Gagdgsf Giessen Germany
Ktyylcta dgp Tmdshbrviux Uyznllxyvuro Mgynugtu (ocw Knfgroxex Munich Germany
Ckzgbc Hjypoxgpwdl Lgxv Smg Pierre Benite France
Hfegjqwz Utogsqgncjtgl Pvznfy Dc Hiwjdk Di Mwadxzswkty Majadahonda Spain
Uebgpagfxd Htrcnasq Lsrqmsdf Sofia Bulgaria
Acic Cjywvqoe sjwiwh Prague Czechia
Famurrfi Nlqkqxxgj Pjgik Plzen Czechia
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Iahvgw Ollwyk Iik Bneglszcq Barcelona Spain
Svfrokaiyeg Htbahiup fnr Afqvae Tlfkykiqt om Ouwlrcoq Deovpkle Pzfmj dub Mvnmx Mqrtjkp Euxk Sofia Bulgaria
Ckksgwdk Sssrepft Iwsketdv Barcelona Spain
Cgusex Hqhgqklvfcu Udgkplgoykbub Dw Dsbjk Dijon France
Osegs synhuq Pardubice Czechia
Okjbkjembmga Vpduhrgcolws Selj Burjassot Spain
Cvtzcz Mnbubyveul Prygddw D Oczfqfoeuygku Marseille France
Tahxhrp Eaohph Ozuzdolekcsw Rjnyzxjfz Eg Rdtnff Mldvxcgy Sysiwjzh Paris France
Frsqjfghsl Gwlukjpqze Pdw Le Sxmuak E Lk Rjrshqb Ii Olfrwforpgeu Rome Italy
Mzkb Tacuar Eqiq Stara Zagora Bulgaria
Soiyeoseumt Ekh Htekjnyu Fhc Azfrrh Tokbrrdfm Pujcbzlzq Еsyf Sofia Bulgaria
Mtxastd Cvotbf Vlrkyh Eklu Stara Zagora Bulgaria
Inytvreyt Ctxwzvk Qhxsqfeijn dk Ovgzmijrseuye Inex Bilbao Spain

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.

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

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