Tests EYE201 eye injection against aflibercept in wet age-related macular degeneration
Compares an eye injection, EYE201, with aflibercept in adults with wet macular degeneration.
Plain-language title generated from the registry record
Registry title: 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)
Key facts
- Where
- Bonn, Frankfurt am Main, Hamburg, Hanover, Munich, Munster, and Tuebingen, GermanySee the 7 sites
- Phase
- Phase 2/3
AI summary: who the study is looking for
From the trial's eligibility criteria. 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 been treated yet. It compares EYE201/MK-8748 with aflibercept.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Treatment-naive choroidal neovascularization (CNV) from age-related macular degeneration in at least one eye (the study eye). NVAMD diagnosed within 21 days before starting treatment. Vision loss in that eye mainly due to NVAMD.
- Earlier treatment
- No earlier anti-VEGF or other injection into the eye (intravitreal therapy) in the study eye. No earlier macular laser treatment in the study eye.
Main reasons for not taking part
- Uncontrolled blood pressure at screening
- History of uveitis in either eye
- Uncontrolled glaucoma in the study eye
- Other active retinal disease in the study eye
- Cataract or glaucoma surgery, or Yag laser capsulotomy, in the study eye within 90 days
Read by machine on 9 November 2026.
Where in Germany
- Universitaetsklinikum Bonn AöRBonn, GermanyTaking people
- University Hospital FrankfurtFrankfurt am Main, GermanyTaking people
- University Medical Center Hamburg-EppendorfHamburg, GermanyTaking people
- Medizinische Hochschule HannoverHanover, GermanyTaking people
- Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)Munich, GermanyTaking people
- Augenzentrum Am St Franziskus-Hospital MuensterMunster, GermanyTaking people
- Universitaetsklinikum Tuebingen AöRTuebingen, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorTrial details
- Who runs it
- Eyebiotech Limited
- Trial code
- EU 2025-524575-22-00
- Record updated
- 12 June 2026
- Original description
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 1Read full original descriptionShow less
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)
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
Inclusion: 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.
Exclusion: 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; History of uveitis in either eye; Active retinal disease other than the condition under investigation in the study eye; Has uncontrolled blood pressure at screening; Has uncontrolled glaucoma in the study eye.