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
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
- Diseases
- Macular degeneration
- 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
Sites (28)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitaetsklinikum Bonn AöR | Bonn | Germany | Recruiting |
| University Hospital Frankfurt | Frankfurt am Main | Germany | Recruiting |
| University Medical Center Hamburg-Eppendorf | Hamburg | Germany | Recruiting |
| Medizinische Hochschule Hannover | Hanover | Germany | Recruiting |
| Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) | Munich | Germany | Recruiting |
| Augenzentrum Am St Franziskus-Hospital Muenster | Munster | Germany | Recruiting |
| Universitaetsklinikum Tuebingen AöR | Tuebingen | Germany | Recruiting |
| East Tallinn Central Hospital | Tallinn | Estonia | Recruiting |
| Silmaarst Krista Turman OÜ | Tallinn | Estonia | Recruiting |
| Silmalaser OÜ | Tallinn | Estonia | Recruiting |
| Tartu University Hospital | Tartu Linn | Estonia | Recruiting |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | Recruiting |
| Centro De Oftalmologia Barraquer S.A. | Barcelona | Spain | Recruiting |
| Institut Catala De Retina S.L. | Barcelona | Spain | Recruiting |
| Hospital Universitario Puerta de Hierro de Majadahonda | Majadahonda | Spain | Recruiting |
| Riga East University Hospital - Department of Ophthalmology, Clinical Center "Bikernieki" | Riga | Latvia | Recruiting |
| Pauls Stradins Clinical University Hospital | Riga | Latvia | Recruiting |
| Northern Kurzeme Regional Hospital | Ventspils | Latvia | Recruiting |
| Uniwersytecki Szpital Kliniczny w Bialymstoku | Bialystok | Poland | Recruiting |
| Oculomedica Sp. z o.o. | Bydgoszcz | Poland | Recruiting |
| OFTALMIKA Sp. z o.o | Bydgoszcz | Poland | Recruiting |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie | Cracow | Poland | Recruiting |
| Centrum Medyczne Dietla 19 Sp. z o.o. | Cracow | Poland | Recruiting |
| Profesorskie Centrum Medyczne Sp. z o.o. | Gdansk | Poland | Recruiting |
| Gabinet Okulistyczny Prof Edward Wylegala | Katowice | Poland | Recruiting |
| Centrum Diagnostyki i Mikrochirurgii Oka-Lens Sp. z o.o. | Olsztyn | Poland | Recruiting |
| Caminomed Sp. z o.o. | Tarnowskie Góry | Poland | Recruiting |
| Warszawski Szpital Okulistyczny Sp. z o.o. | Warsaw | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.