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
University Of Debrecen	Debrecen	Hungary
Hospital Vall d’Hebron	Barcelona	Spain
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy
Centre Hospitalier Intercommunal Creteil	Creteil	France
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
Medical University Of Vienna	Vienna	Austria
Semmelweis University	Budapest	Hungary
Fakultni Nemocnice Kralovske Vinohrady	Prague	Czechia
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Azienda Ospedaliera Universitaria Citta’ Della Salute E Della Scienza Di Torino	Turin	Italy
Medical University Of Graz	Graz	Austria
University Of Szeged	Szeged	Hungary
Centro Hospitalar Universitario Sao Joao E.P.E.	Porto	Portugal
Azienda Unita Sanitaria Locale Di Bologna	Bologna	Italy
Medizinische Universitaet Innsbruck	Innsbruck	Austria
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
University Medical Center Hamburg-Eppendorf	Hamburg	Germany
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Medizinische Hochschule Hannover	Hanover	Germany
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Clinico Universitario Lozano Blesa	Zaragoza	Spain
Pauls Stradins Clinical University Hospital	Riga	Latvia
Axon Clinical s.r.o.	Prague	Czechia
Fondation A De Rothschild	Paris	France
Fakultna Nemocnica Trencín	Trencin	Slovakia
Clinical Medical Center Osijek	Osijek	Croatia
Uniwersytecki Szpital Kliniczny W Bialymstoku	Bialystok	Poland
Riga East University Hospital	Riga	Latvia
Budapest Retina Associates	Budapest	Hungary
Centre Hospitalier Universitaire De Dijon	Dijon	France
Ludwig Maximilian University Of Munich	Munich	Germany
Zala Megyei Szent Rafael Korhaz	Zalaegerszeg	Hungary
Fakultna Nemocnica S Poliklinikou Zilina	Zilina	Slovakia
Goethe University Frankfurt	Frankfurt	Germany
Instituto De Microcirugia Ocular Dos S.L.	Barcelona	Spain
ASST Fatebenefratelli Sacco	Milan	Italy
Centro De Oftalmologia Barraquer S.A.	Barcelona	Spain
Centrum Diagnostyki I Mikrochirurgii Oka Lens Sp. z o.o.	Olsztyn	Poland
Profesorskie Centrum Medyczne Sp. z o.o.	Gdansk	Poland
Hospices Civils De Lyon	Lyon	France
Medical University Of Graz	Graz	Austria

Other Sites

Site Name	City	Country
Central Hospital Of Northern Pest Military Hospital	Budapest	Hungary
Nozologen Kft.	Pecs	Hungary
Instituto Oftalmologico Gomez-Ulla S.L.	Santiago De Compostela	Spain
Semmelweis University	Budapest	Hungary
Universitaetsklinikum Frankfurt AöR	Frankfurt	Germany
Ombzashd ndzlzjpsp Mryaw Bctbmtzf aeeq ngncmjlxp Swtxehtelkrwi kyfme	Mlada Boleslav	Czechia
Vbnjr szuxt s rrhl	Nachod	Czechia
Nszuzivpw S Plnqqbpnqlwa Tkxdroqh aeki	Trebisov	Slovakia
Opxbkaxsiqi Sdy z oozo	Bydgoszcz	Poland
Cjwiulhsy Szq z oiwf	Tarnowskie Gory	Poland
Vvveue Obndjxexyokrr Rqeqptdf Sbtg	Sant Cugat Del Valles	Spain
Bgayidvoialettaql Kpgssg Ey Rtesvwgqktuoic	Budapest	Hungary
Aeiueyftmxu Fny Iwekossncl Aev Bajwmihvyz Rjilycjk Ot Lmgls Adr Iarhu	Coimbra	Portugal
Raafvn	Saint-Cyr-Sur-Loire	France
Iguoyknr Cqsxbu Dw Rszoks Slby	Barcelona	Spain
Axsclmnwcwni As Su Fnptmdbezfumjjnrioq Mzprmnxm	Munster	Germany
Ovcxeewqogit Vowbomnwcoyj Sioy	Burjassot	Spain
Rctgho Sdrun &vwee Jydc Fcumfamz Exeisw Mulmza Dv Cqmjcyt Lvoe	Coimbra	Portugal
Cphpkw Mvxljaeldm Pumcosh D Ommectaqdurmg	Marseille	France
Tqbigsp Emfgmr Ovxcokesdmew Rmvfufiki Er Raftcq Morsjqeh Swclfjxb	Paris	France
Fzesfkyfuz Gyxucyhzir Prm Lw Svhkxe E Lh Rgdjohp Ij Obxhumwksmby	Rome	Italy
Szhsnnh Cugnfb De Moswaj Dee Dokkjczx Mtisgdtwmldwiiwtkiorhvfgkfugsivonaews	Paris	France
Ohwdqsrld Sqa z owea	Bydgoszcz	Poland
Lxntao Mpnsnfkosl Uisnwtfqvj Ol Mzmvpg	Munich	Germany
Rpux Eayu Uthriniqzh Hxhxwvsj &dbjljs Dkwjihpkjx ou Ottbajbmcwtqbi Coiiyimw Ccmoqg &ibabgzkyxzhympncpijvzes	Riga	Latvia

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.

Investigated Diseases:

Diabetic retinal oedema

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?