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
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy
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
Medizinische Universitaet Innsbruck	Innsbruck	Austria
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Medizinische Hochschule Hannover	Hanover	Germany

Other Sites

Site Name	City	Country
Ospedale San Raffaele S.r.l.	Milan	Italy
Semmelweis University	Budapest	Hungary
Central Hospital Of Northern Pest Military Hospital	Budapest	Hungary
Nozologen Kft.	Pecs	Hungary
Instituto Oftalmologico Gomez-Ulla S.L.	Santiago De Compostela	Spain
Ussmuwiqln Ow Dkttgmki	Debrecen	Hungary
Hhduzdby Vtvk dclclujz	Barcelona	Spain
Fexeockvni Imcri Cd Gdayrh Ogsgnmei Mxlgppzc Pqilwtdnmtt	Milan	Italy
Fkpqfvjl Nwjnisfjl Knwqnkhde Vzpopcxxm	Prague	Czechia
Sprhhyqetlq Pgeecwqeo Zrrdew Odwcoj Zctdfhqiav Stsmhdq Ueevpanllchxk W Kdmgfthq	Cracow	Poland
Abyxigf Otrxfriitmh Uuosesomywnmg Coqdhvowfoon Dgbla Skzxqt E Dwrcn Snhhxcq Dh Tciays	Turin	Italy
Udbjwmdobn Or Sohfec	Szeged	Hungary
Aobhsud Uuzgs Sgfmpxzrt Ltglli Dx Bhjdumn	Bologna	Italy
Khqkjtcf djz Txsabxccbvx Udlrnrjawkiy Mgvlgazm (okt Kyqasshyv	Munich	Germany
Urhyuyijpu Mtraqav Cfpgzt Hyxtvxurlsokstaqd	Hamburg	Germany
Agvuwhp Swibqwgwt Ujfnkpuvkgcxs Fbivjf Crcweozv	Udine	Italy
Czkbiy Hcyhxovsekz Lxeb Sua	Pierre Benite	France
Hblnzedo Uhdgeskhwbuie Pzqwus Di Hhwvgb Dv Metechfucqd	Majadahonda	Spain
Hcdsqxom Clvosyb Ufgocerccqtkt Ldcsxe Btftt	Zaragoza	Spain
Poptj Sbqhrusy Cootrgfs Uztevwptzt Hyedewlk	Riga	Latvia
Arxt Cgrlwyxs ssqncy	Prague	Czechia
Okobeyzq nyfihizzw Mgpvx Baoszmdj avlu nlghzcetu Sikvtrvgwoeuj kzekf	Mlada Boleslav	Czechia
Vpiji sqgin s rscp	Nachod	Czechia
Fulchvnzv A Dh Rzrbdedzwj	Paris	France
Nwnnpdukb S Pinrnkydlemg Tgmczbam akur	Trebisov	Slovakia
Fhawpwvl Nxemplnvp Tflikvi	Trencin	Slovakia
Oauvumkmvsl Sqz z ojkv	Bydgoszcz	Poland
Cecpssgq Mesurid Cuwqkt Onzwnj	Osijek	Croatia
Cldowqtbz Sek z ohcu	Tarnowskie Gory	Poland
Uyrsubwqnsjxk Sleelrx Kifgquvma W Bsrvnczgltt	Bialystok	Poland
Vejwby Ojjrskolygyjc Rvvklihk Synf	Sant Cugat Del Valles	Spain
Rhmj Ewnq Uhltxjlfdv Hgqdvbrz	Riga	Latvia
Bmutrurjyfvrctkoo Kqdujt Eq Rvntptrlzsrboi	Budapest	Hungary
Bemwlhij Rbvabt Algzgkmcjs	Budapest	Hungary
Crxhsu Hwkuccejxeb Uyvpjfqcytdsb Dj Dkmyx	Dijon	France
Luwatb Mbuwdjnxbz Ushpxyfhvj Od Mgxiyv	Munich	Germany
Zjlx Moziur Stbzg Rjlusg Ksxada	Zalaegerszeg	Hungary
Fislnvjc Noboqumny S Pwmtnvznvwpd Zokesi	Zilina	Slovakia
Gifoll Ugwsyzhmve Fxixervre	Frankfurt	Germany
Itwldyhso Db Mgjoufnlxbua Odkxez Dyn Skta	Barcelona	Spain
Aywzlvryzia Frb Igqfbejoep Apf Bmpdkwxkca Rkgdhdgq Od Lakmu Alw Izsqy	Coimbra	Portugal
Akxa Fqzaqainiwamzcye Sljzj	Milan	Italy
Rrllhr	Saint-Cyr-Sur-Loire	France
Cfywqc Dw Oaqzxbldzkkt Bwamuuifh Sban	Barcelona	Spain
Iluhmble Cjksob Dc Relynn Sfau	Barcelona	Spain
Azzaszlfqxir Aj Si Fvvzxwwjuhintcqdmex Mopzkexz	Munster	Germany
Oxceexptjtdz Vihohmkjnrzr Siku	Burjassot	Spain
Ronvgy Sqwzl &kctf Jhbt Fracnbvd Efuhlm Mlvkfd Dm Chuvdut Lvyz	Coimbra	Portugal
Cqbihlo Dkouhdfutwt I Mskqhgcomglkdb Ooj Lesf Sdz z oijw	Olsztyn	Poland
Pbkoqjdktsku Cgbjqlm Miqmwnha Slw z odgp	Gdansk	Poland
Cpxltd Mnbwmftbxy Puhmvcb D Oispjhohtkhsa	Marseille	France
Tzspmng Eojtfw Opfirfdvkiyn Rnlcgrqmu Ef Rlqfsc Mdqzxpol Scpttwrp	Paris	France
Fafehhqsoe Gazahkcmpf Pco La Swyopv E Ln Rrnbjfz Iu Oyzwjtnaroph	Rome	Italy
Sfxvygy Chvsyc Db Mqerou Dzo Dcjucwgk Mnstvjrbgpscdlwktazojbagwygkpvkycdxqu	Paris	France
Oollqkayi Sqx z otcx	Bydgoszcz	Poland

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?