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2025-524575-22-00RecruitingPhase 2/3

A randomized double-masked, multicenter, 3 arm pivotal Phase 2/3 study to evaluate the efficacy and safety of intravitreal (IVT) EYE201/MK-8748 in participants with neovascular age-related macular degeneration (NVAMD)

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 12 Jun 2026

Next steps

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
130 (estimated)
First submitted
5 Feb 2026
Start date
30 Jun 2026
Lead sponsor
Eyebiotech Limited
EU CT number
2025-524575-22-00

What you commit to

  • Study type: Interventional · Phase 2/3
  • Planned participants: 130
  • 28 sites in 5 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.

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
  • 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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (28)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Universitaetsklinikum Bonn AöRBonnGermanyRecruiting
University Hospital FrankfurtFrankfurt am MainGermanyRecruiting
University Medical Center Hamburg-EppendorfHamburgGermanyRecruiting
Medizinische Hochschule HannoverHanoverGermanyRecruiting
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)MunichGermanyRecruiting
Augenzentrum Am St Franziskus-Hospital MuensterMunsterGermanyRecruiting
Universitaetsklinikum Tuebingen AöRTuebingenGermanyRecruiting
East Tallinn Central HospitalTallinnEstoniaRecruiting
Silmaarst Krista Turman OÜTallinnEstoniaRecruiting
Silmalaser OÜTallinnEstoniaRecruiting
Tartu University HospitalTartu LinnEstoniaRecruiting
Hospital Universitari Vall d'HebronBarcelonaSpainRecruiting
Centro De Oftalmologia Barraquer S.A.BarcelonaSpainRecruiting
Institut Catala De Retina S.L.BarcelonaSpainRecruiting
Hospital Universitario Puerta de Hierro de MajadahondaMajadahondaSpainRecruiting
Riga East University Hospital - Department of Ophthalmology, Clinical Center "Bikernieki"RigaLatviaRecruiting
Pauls Stradins Clinical University HospitalRigaLatviaRecruiting
Northern Kurzeme Regional HospitalVentspilsLatviaRecruiting
Uniwersytecki Szpital Kliniczny w BialymstokuBialystokPolandRecruiting
Oculomedica Sp. z o.o.BydgoszczPolandRecruiting
OFTALMIKA Sp. z o.oBydgoszczPolandRecruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W KrakowieCracowPolandRecruiting
Centrum Medyczne Dietla 19 Sp. z o.o.CracowPolandRecruiting
Profesorskie Centrum Medyczne Sp. z o.o.GdanskPolandRecruiting
Gabinet Okulistyczny Prof Edward WylegalaKatowicePolandRecruiting
Centrum Diagnostyki i Mikrochirurgii Oka-Lens Sp. z o.o.OlsztynPolandRecruiting
Caminomed Sp. z o.o.Tarnowskie GóryPolandRecruiting
Warszawski Szpital Okulistyczny Sp. z o.o.WarsawPolandRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.