Study on EYE103 and 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 treatment known as Ranibizumab. Both treatments are given as injections directly into the eye, a method known as intravitreal use. The purpose of the study is to see if EYE103 is as effective as Ranibizumab in improving vision.

Participants in the study will receive either EYE103 or Ranibizumab, or a placebo, over a period of time. The study will last for about a year, during which participants will have regular check-ups to monitor their vision and overall eye health. The main goal is to measure changes in vision using a special eye chart designed for people with diabetic eye conditions. This will help determine if EYE103 can maintain or improve vision as effectively as the current treatment.

In addition to EYE103 and Ranibizumab, a substance called Fluorescein Sodium may be used during the study. This is a type of contrast agent that helps doctors see the blood vessels in the eye more clearly during examinations. The study aims to provide valuable information about the safety and effectiveness of EYE103 for people with Diabetic Macular Edema, potentially offering a new option for managing this condition.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, you will undergo a series of assessments to confirm your eligibility for the trial. This includes a review of your medical history and a comprehensive eye examination.

If you are a female participant of childbearing potential, a pregnancy test will be conducted to ensure eligibility. You will also be required to agree to use an acceptable method of contraception during the study and for 30 days after the last dose of the study drug.

2 randomization and first treatment

After confirming eligibility, you will be randomly assigned to one of the study groups. This means you will receive either EYE103 or ranibizumab (also known as Lucentis).

The first dose of the study medication will be administered through an injection into the eye, a procedure known as intravitreal use. The dosage for EYE103 will be either 0.5 mg or 0.8 mg, while ranibizumab will be administered at a dose of 0.5 mg.

3 follow-up visits

You will attend regular follow-up visits throughout the study period, which lasts up to 52 weeks. These visits are crucial for monitoring your response to the treatment and ensuring your safety.

During these visits, your vision will be assessed using a standardized chart to measure any changes in your visual acuity. This is known as the ETDRS chart, which stands for Early Treatment of Diabetic Retinopathy Study.

4 ongoing treatment

You will continue to receive the assigned study medication at regular intervals as determined by the study protocol. The frequency of these injections will be explained to you during your visits.

It is important to attend all scheduled appointments and follow the instructions provided by the study team to ensure the best possible outcomes.

5 final assessment

At the end of the study period, a final assessment will be conducted. This will include a comprehensive eye examination and a review of your overall health status.

The primary goal of this assessment is to evaluate the change in your visual acuity from the start of the study to the end, using the ETDRS chart.

Who Can Join the Study?

  • 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 pregnancy test at the start of the study and further negative tests before each dose of study medication if you are of childbearing potential. This includes women 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 sterile. You must agree to use an acceptable method of birth control for 30 days after the last dose of study drug.
  • If male, be surgically sterile 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.

Who Cannot Join the Study?

  • Patients who do not have Diabetic Macular Edema cannot participate.
  • Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important to check if you qualify.
  • Both male and female patients are eligible, so gender is not a reason for exclusion.
  • Patients who are part of a vulnerable population are not eligible. This typically means groups that may need special protection, like children or those unable to give consent.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
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 Clinico Universitario Lozano Blesa Zaragoza Spain
Centre Monticelli Paradis D Ophtalmologie Marseille France
Societe Civile De Moyens Des Docteurs Maury-Francais-Coscas-Favard-Krivosic Paris France
Retina Saint-Cyr-Sur-Loire France
Theorie Etudes Organisation Recherche En Retine Medicale S.A.R.L. Paris France
Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia Rome Italy
Centro De Oftalmologia Barraquer S.A. Barcelona Spain
Oftalmologia Vistahermosa S.L. Burjassot Spain
Institut Catala De Retina S.L. Barcelona Spain
Oftex s.r.o. Pardubice Czechia
Augenzentrum Am St Franziskus-Hospital Muenster Munster Germany
Institut Fuer Forschung Und Innovation In Der Augenchirurgie Vienna Austria
Rufino Silva & Joao Figueira Espaco Medico De Coimbra Lda. Coimbra Portugal
Association For Innovation And Biomedical Research On Light And Image Coimbra Portugal
Nozologen Kft. Pecs Hungary
Centrum Diagnostyki I Mikrochirurgii Oka Lens Sp. z o.o. Olsztyn Poland
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
Riga East University Hospital – Department of Ophthalmology, Clinical Center “Bikernieki” Riga Latvia
Acjw Ciidznkj suuvyg Prague Czechia
Ujuqoyyrvo Mznisrc Cxspyu Hquunycididfzggoi Hamburg Germany
Oznyfasj nkclftdlk Mmccg Bwkfckoc arpc nhqkklkzu Suwnwarztaiwp kxaxx Mlada Boleslav Czechia
Vmnrd sgjcp s rmck Nachod Czechia
Neywzpxyy S Pvjdalzpcins Tpysmchi acgy Trebisov Slovakia
Vwhgal Oplc kzhuknl Bratislava Slovakia
Vbhyvm Oqmmqjzzcihpy Rlwrejcv Scso Sant Cugat Del Valles Spain
Oqajaczibkz Sik z oxcp Bydgoszcz Poland
Cddxpttvq Soh z oqwg Tarnowskie Gory Poland
Pmxllbdvioay Crhcxbp Msyhwwbd Sbr z ougv Gdansk Poland
Cawsms Hhsqqoeomae Uynuwcuyerggt Dh Demvp Dijon France
Aydhsdi Obubybjknjb Unsscvlwjlnvj Clxvdqzshhvc Drquh Svhoza E Dlacy Seiikhe Dx Tfsopt Turin Italy
Apzxjcf Urtib Snsigejtm Lmumvp Da Bsmwaln Bologna Italy
Iprodaynl De Mxzngysganlx Oikity Drq Sjff Barcelona Spain
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Gtxzab Udrtxlkiwh Fequobmrc Frankfurt Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
01.09.2024
Croatia Croatia
Not recruiting
01.09.2024
Czechia Czechia
Not recruiting
01.09.2024
France France
Not recruiting
01.09.2024
Germany Germany
Not recruiting
01.09.2024
Hungary Hungary
Not recruiting
01.09.2024
Italy Italy
Not recruiting
01.09.2024
Latvia Latvia
Not recruiting
01.09.2024
Poland Poland
Not recruiting
01.09.2024
Portugal Portugal
Not recruiting
01.09.2024
Slovakia Slovakia
Not recruiting
01.09.2024
Spain Spain
Not recruiting
01.09.2024

Trial locations

EYE103 is a new medication being tested in this clinical trial. It is given as an injection into the eye and is being studied to see if it can help improve vision in people with diabetic macular edema, a condition that affects the retina and can lead to vision loss. The goal is to see if EYE103 can work as well as another treatment already used for this condition.

Ranibizumab is a medication that is already used to treat diabetic macular edema. It is also given as an injection into the eye. Ranibizumab works by blocking a protein that can cause abnormal blood vessels to grow and leak in the eye, which can lead to vision problems. In this trial, it is being used as a comparison to see how well EYE103 performs in improving vision.

Investigated diseases:

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 linked to the duration and control of diabetes, with prolonged high blood sugar levels increasing the risk. Over time, the accumulation of fluid can cause persistent vision problems if not managed. The condition is a common complication of diabetic retinopathy, which is a broader term for diabetes-related damage to the retina.

Trial ID:
2024-510944-30-00
Protocol code:
EYE-RES-102
Trial Phase:
Therapeutic use (Phase IV)

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