2025-524894-17-00RecruitingPhase 2/3
A clinical trial of EYE201/MK-8748 in people with macular degeneration (MK-8748-003)
A randomized double-masked, multicenter, 3-arm, pivotal Phase 2/3 study to evaluate the efficacy and safety of intravitreal (IVT) EYE201/MK-8748 compared to aflibercept (2 mg) in participants with neovascular age-related macular degeneration (NVAMD)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 10 Sept 2026
Brief summary (registry, in English)
The primary objective is to demonstrate that EYE201/MK-8748 is non-inferior to aflibercept with respect to mean change in BCVA (ETDRS letters) from baseline to Year 1
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- First submitted
- 25 Feb 2026
- Start date
- 22 Jun 2026
- Lead sponsor
- Eyebiotech Limited
- Diseases
- Macular degeneration
- EU CT number
- 2025-524894-17-00
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 250
- 55 sites in 10 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with newly diagnosed wet age-related macular degeneration (NVAMD) who have not had treatment in the affected eye.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Treatment-naive choroidal neovascularization due to age-related macular degeneration in at least one eye, diagnosed within 21 days before starting treatment. Vision loss must mainly come from NVAMD.
- Earlier treatment
- No earlier anti-VEGF or other intravitreal treatment in the study eye. No earlier macular laser treatment in the study eye.
Main reasons for not taking part
- Uncontrolled blood pressure at screening
- Uveitis in either eye in the past
- Uncontrolled glaucoma in the study eye
- Other active retinal disease in the study eye
- Cataract surgery, glaucoma surgery or Yag laser capsulotomy in the study eye within 90 days before entering the study
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of any prior macular laser photocoagulation in the study eye
- History of cataract surgery, minimally invasive glaucoma surgery, or Yttrium-Aluminium Garnet (Yag) laser capsulotomy in the study eye within 90 days before entering the study
- Has previously received anti- vascular endothelial growth factor (VEGF) therapy or other intravitreal (IVT) therapy in the study eye
Other illness
- History of uveitis in either eye
- Has active retinal disease other than the condition under investigation in the study eye
Other
- Has uncontrolled blood pressure at screening
- Has uncontrolled glaucoma in the study eye
Who the study is looking for
- Has treatment naive choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) including subfoveal, juxtafoveal and extrafoveal lesions or retinal angiomatous proliferations (RAP) and polypoidal choroidal vascularization (PCV) lesions in at least one eye (study eye)
- The diagnosis of neovascular age-related macular degeneration (NVAMD) must have been made within 21 days prior to starting study treatment
- Has a decrease in vision in the study eye that has been determined by the Investigator to be primarily the result of NVAMD
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (55)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Graz | Graz | Austria | Recruiting |
| Medizinische Universitaet Innsbruck | Innsbruck | Austria | Recruiting |
| Institut Fuer Forschung Und Innovation In Der Augenchirurgie | Vienna | Austria | Recruiting |
| Medical University of Vienna | Vienna | Austria | Recruiting |
| Oblastni nemocnice Mlada Boleslav, a.s., nemocnice Stredoceskeho kraje | Mladá Boleslav | Czechia | Recruiting |
| VISUS, spol s.r.o. | Náchod | Czechia | Recruiting |
| Fakultni nemocnice Ostrava | Ostrava | Czechia | Recruiting |
| Astra Clinic.s.r.o. | Prague | Czechia | Recruiting |
| Fakultni nemocnice Kralovske Vinohrady | Prague | Czechia | Recruiting |
| Axon Clinical s.r.o. | Prague 5 | Czechia | Recruiting |
| Rigshospitalet | Glostrup | Denmark | Recruiting |
| Zealand University Hospital | Køge | Denmark | Recruiting |
| Instituto De Microcirugia Ocular Dos S.L. | Barcelona | Spain | Recruiting |
| Oftalmologia Vistahermosa S.L. | Burjassot | Spain | Recruiting |
| Valles Ophthalmology Research S.L. | Sant Cugat Del Valles | Spain | Recruiting |
| Miranza Galicia S.L. | Santiago De Compostela | Spain | Recruiting |
| Hospital Clinico Universitario Lozano Blesa | Zaragoza | Spain | Recruiting |
| Centre Hospitalier Intercommunal Créteil | Créteil | France | Recruiting |
| Centre Hospitalier Universitaire de Dijon | Dijon | France | Recruiting |
| Pole Vision Val d'Ouest | Écully | France | Recruiting |
| Hospices Civils De Lyon | Lyon Cedex 04 | France | Recruiting |
| Centre Monticelli Paradis d'Ophtalmologie | Marseille | France | Recruiting |
| Theorie Etudes Organisation Recherche En Retine Medicale S.A.R.L. | Paris | France | Recruiting |
| Societe Civile De Moyens Des Docteurs Maury-Francais-Coscas-Favard-Krivosic | Paris | France | Recruiting |
| Fondation A. de Rothschild | Paris | France | Recruiting |
| Retina | Saint-Cyr-Sur-Loire | France | Recruiting |
| Klinički bolnički centar Osijek | Osijek | Croatia | Recruiting |
| Specijalna bolnica Svjetlost | Zagreb | Croatia | Recruiting |
| Budapesti Jahn Ferenc Del-pesti Korhaz es Rendelointezet | Budapest | Hungary | Recruiting |
| Central Hospital Of Northern Pest Military Hospital | Budapest VI | Hungary | Recruiting |
| Semmelweis University | Budapest VIII | Hungary | Recruiting |
| Budapesti Bajcsy-Zsilinszky Korhaz Es Rendelointezet | Budapest X | Hungary | Recruiting |
| Budapest Retina Associates Kft. | Budapest XIII | Hungary | Recruiting |
| University of Debrecen | Debrecen | Hungary | Recruiting |
| Nozologen Kft. | Pécs | Hungary | Recruiting |
| University of Szeged | Szeged | Hungary | Recruiting |
| Zala Varmegyei Szent Rafael Korhaz | Zalaegerszeg | Hungary | Recruiting |
| University Hospital Of Ferrara | Ferrara | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Careggi | Florence | Italy | Recruiting |
| ASST Fatebenefratelli Sacco | Milan | Italy | Recruiting |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico | Milan | Italy | Recruiting |
| Ospedale San Raffaele S.r.l. | Milan | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Rome | Italy | Recruiting |
| Azienda Ospedaliera Policlinico Universitario Tor Vergata | Rome | Italy | Recruiting |
| Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia | Rome | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino | Turin | Italy | Recruiting |
| Azienda Sanitaria Universitaria Friuli Centrale | Udine | Italy | Recruiting |
| Unidade Local De Saude De Almada-Seixal E.P.E. | Almada | Portugal | Recruiting |
| Rufino Silva & Joao Figueira Espaco Medico De Coimbra Lda. | Coimbra | Portugal | Recruiting |
| Unidade Local de Saúde de Coimbra, E.P.E. | Coimbra | Portugal | Recruiting |
| Association For Innovation And Biomedical Research On Light And Image | Coimbra | Portugal | Recruiting |
| Euromedix a.s. | Petrzalka | Slovakia | Recruiting |
| Nemocnica s poliklinikou Trebisov a.s. | Trebišov | Slovakia | Recruiting |
| Fakultna nemocnica Trencin | Trenčín | Slovakia | Recruiting |
| Fakultna nemocnica s poliklinikou Zilina | Žilina | Slovakia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.