Study on the Effectiveness and Safety of EYE103 Compared to Ranibizumab for Patients with Diabetic Macular Edema

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What is this study about?

This clinical trial is focused on studying a condition called Diabetic Macular Edema, which affects the eyes of people with diabetes and can lead to vision problems. The study will compare the effects of a new treatment called EYE103 with an existing medication known as ranibizumab. Both treatments are given as a solution for injection directly into the eye, a method known as intravitreal use.

The purpose of the study is to evaluate whether EYE103 is as effective as ranibizumab in improving vision in people with Diabetic Macular Edema. Participants in the study will receive either EYE103 or ranibizumab over a period of time, and their vision will be monitored to see how it changes. The study will last for about a year, with regular check-ups to assess the effects of the treatment.

During the study, participants will have their vision tested using a standardized chart called the ETDRS chart, which helps measure changes in vision clarity. The study aims to determine if EYE103 can provide similar benefits to ranibizumab in terms of improving vision over the course of the study. This research is important for finding effective treatments for people with Diabetic Macular Edema and improving their quality of life.

1 joining the study

Upon joining the study, participants will be required to provide written informed consent. This confirms understanding of the study procedures and the associated risks.

Participants must be at least 18 years old. Female participants of childbearing potential must have a negative pregnancy test before each dose and agree to use effective contraception during the study and for three months after the last dose. Male participants must agree to use contraception during the study and for 90 days after the last dose.

2 initial assessment

An initial assessment will be conducted to establish a baseline for the study. This includes measuring the **BCVA** (Best Corrected Visual Acuity) using the standardized **ETDRS** (Early Treatment Diabetic Retinopathy Study) chart.

3 treatment administration

Participants will be randomly assigned to receive either **EYE103** or **ranibizumab**. Both are administered as a solution for injection directly into the eye, a process known as **intravitreal use**.

The dosage for **ranibizumab** is 0.5 mg. For **EYE103**, the dosage may be either 0.5 mg or 0.8 mg. The frequency and duration of administration will be determined by the study protocol.

4 ongoing assessments

Throughout the study, regular assessments will be conducted to monitor changes in **BCVA**. These assessments will occur up to and including Week 52.

The primary goal is to evaluate the change in vision from the start of the study to the end of the first year.

5 completion of study

The study is expected to conclude by June 30, 2028. Participants will have completed all required assessments and treatments by this time.

Final evaluations will be conducted to assess the overall efficacy and safety of the treatments.

Who Can Join the Study?

Participants must be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity.
Be male or female and at least 18 years old.
If female, have a negative blood pregnancy test at the start and further negative urine tests before each dose of study medication if the participant is a female who can have children. This includes those who have had less than 2 years since the start of menopause, have not had a period for less than 1 year, or are not surgically unable to have children. Such participants must agree to use a highly effective method of birth control from the start of the study up to and including 3 months after the last dose of study drug. She must also agree not to donate eggs from the start of the study up to and including 3 months after the last dose of study drug.
If male, be surgically unable to have children for at least 12 weeks, or agree to use an acceptable method of birth control, such as a condom, and a second highly effective method of birth control from the start of the study up to and including 90 days after the last dose of study drug. He must also agree not to donate sperm from the time of the first dose until 12 weeks after the last dose of study drug.

Who Cannot Join the Study?

Patients with any other eye disease that could affect vision.
Patients who have had eye surgery in the last 3 months.
Patients with an eye infection or inflammation.
Patients who are allergic to any of the study medications.
Patients who are pregnant or breastfeeding.
Patients with uncontrolled diabetes or high blood pressure.
Patients who have had a stroke or heart attack in the last 6 months.
Patients who are participating in another clinical trial.
Patients with a history of drug or alcohol abuse.
Patients with any condition that the study doctor thinks would make it unsafe for them to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medizinische Universitaet Innsbruck	Innsbruck	Austria
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Medizinische Hochschule Hannover	Hanover	Germany
Centre Hospitalier Intercommunal Creteil	Creteil	France
Medical University Of Vienna	Vienna	Austria
Medical University Of Graz	Graz	Austria
Centro Hospitalar Universitario Sao Joao E.P.E.	Porto	Portugal
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy

Other Sites

Site Name	City	Country
Central Hospital Of Northern Pest Military Hospital	Budapest	Hungary
Pauls Stradins Clinical University Hospital	Riga	Latvia
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
ASST Fatebenefratelli Sacco	Milan	Italy
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Clinico Universitario Lozano Blesa	Zaragoza	Spain
Centre Monticelli Paradis D Ophtalmologie	Marseille	France
Theorie Etudes Organisation Recherche En Retine Medicale S.A.R.L.	Paris	France
Retina	Saint-Cyr-Sur-Loire	France
Societe Civile De Moyens Des Docteurs Maury-Francais-Coscas-Favard-Krivosic	Paris	France
Augenzentrum Am St Franziskus-Hospital Muenster	Munster	Germany
Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia	Rome	Italy
Association For Innovation And Biomedical Research On Light And Image	Coimbra	Portugal
Rufino Silva & Joao Figueira Espaco Medico De Coimbra Lda.	Coimbra	Portugal
Institut Catala De Retina S.L.	Barcelona	Spain
Centro De Oftalmologia Barraquer S.A.	Barcelona	Spain
Oftalmologia Vistahermosa S.L.	Burjassot	Spain
Centrum Diagnostyki I Mikrochirurgii Oka Lens Sp. z o.o.	Olsztyn	Poland
Nozologen Kft.	Pecs	Hungary
Fondation A De Rothschild	Paris	France
Fakultna Nemocnica Trencín	Trencin	Slovakia
University Of Debrecen	Debrecen	Hungary
Clinical Medical Center Osijek	Osijek	Croatia
Uniwersytecki Szpital Kliniczny W Bialymstoku	Bialystok	Poland
Bajcsy-Zsilinszky Korhaz Es Rendelointezet	Budapest	Hungary
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
Semmelweis University	Budapest	Hungary
Fakultni Nemocnice Kralovske Vinohrady	Prague	Czechia
Ludwig Maximilian University Of Munich	Munich	Germany
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Zala Megyei Szent Rafael Korhaz	Zalaegerszeg	Hungary
Fakultna Nemocnica S Poliklinikou Zilina	Zilina	Slovakia
Centre Hospitalier Lyon Sud	Pierre Benite	France
Instituto Oftalmologico Gomez-Ulla S.L.	Santiago De Compostela	Spain
University Of Szeged	Szeged	Hungary
Budapest Retina Associates	Budapest	Hungary
Oftalmika Sp. z o.o.	Bydgoszcz	Poland
Afkz Chybduvd shkyuf	Prague	Czechia
Uzvwabnsel Makvrmk Cayexi Hbplpgllvcanoveiy	Hamburg	Germany
Vbytz syufm s rkim	Nachod	Czechia
Oxsefaoq nuatuypca Mzkwv Bevrfflp abtj nbphsqqqg Saeoooilydxsy ktyyl	Mlada Boleslav	Czechia
Vltyur Ocjsayulfmsmt Roismkbr Svcp	Sant Cugat Del Valles	Spain
Omagepaierm Sia z oxiy	Bydgoszcz	Poland
Ccgwprdep Sgq z odrw	Tarnowskie Gory	Poland
Nwispinio S Paxyyzlcihsb Tfocfrul aedq	Trebisov	Slovakia
Pfwomnhkdaqm Cmdggmf Mswlfigu Saa z oomv	Gdansk	Poland
Ceyqpf Hptwejbusny Uophlbfipbvtp Dy Drxkr	Dijon	France
Aqfistv Oktytguobji Ugcnxowvaryva Cntwowtuuqrf Dgumi Sauadw E Dorna Sucaybj Dh Troxvj	Turin	Italy
Galmuf Uktoflsefi Fyfvjuwbu	Frankfurt	Germany
Avivlgx Ukanw Swfkeffhy Lzikag Dw Bkxvlja	Bologna	Italy
Iuyaevnxa Dy Mcktjfbpzoiz Oirixb Dut Sbnc	Barcelona	Spain
Rhns Enof Uirzlswtof Hxkgvuak	Riga	Latvia
Hoeznwpb Vuzo doirnmzx	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	01.05.2025
Croatia	Not recruiting	01.05.2025
Czechia	Not recruiting	01.05.2025
France	Not recruiting	01.05.2025
Germany	Not recruiting	01.05.2025
Hungary	Not recruiting	01.05.2025
Italy	Not recruiting	01.05.2025
Latvia	Not recruiting	01.05.2025
Poland	Not recruiting	01.05.2025
Portugal	Not recruiting	01.05.2025
Slovakia	Not recruiting	01.05.2025
Spain	Not recruiting	01.05.2025

Trial locations

Investigated drugs:

EYE103 is a medication being tested in this clinical trial to see if it can help people with diabetic macular edema, a condition that affects the eyes and can lead to vision problems. This medication is given as an injection directly into the eye. The goal is to see if it can improve vision or at least prevent it from getting worse, by comparing it to another medication already used for this condition.

Ranibizumab is a medication already used to treat diabetic macular edema. It is also given as an injection into the eye. This medication works by blocking a substance in the body that can cause abnormal blood vessels to grow in the eye, which can lead to vision problems. In this trial, it is used as a comparison to see if the new medication, EYE103, is just as effective or better at treating the condition.

Diabetic Macular Edema – Diabetic Macular Edema 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 leak fluid, causing the macula to swell. This swelling can lead to blurred or wavy vision and can affect the ability to see fine details. The progression of the disease is often gradual, with symptoms worsening over time if not managed. It is commonly associated with diabetes and can occur in individuals with both type 1 and type 2 diabetes. The condition can affect one or both eyes and is a common cause of vision impairment in people with diabetes.

Trial ID:

2025-520809-12-00

Protocol code:

EYE-RES-103

Trial Phase:

Therapeutic use (Phase IV)

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Study on the Effectiveness and Safety of EYE103 Compared to Ranibizumab for Patients with Diabetic Macular Edema

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?