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Taking people in PolandPhase 2/3

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.

Key facts

Who runs it
Eyebiotech Limited
Where
Bialystok, Bydgoszcz, Cracow, Gdansk, Katowice, Olsztyn, Tarnowskie Góry, and Warsaw, PolandSee the 10 sitesAlso in 4 other countries, 18 sites
Trial code
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)
Status
Recruiting
Phase
Phase 2/3
People taking part
130 people, planned
Started
30 Jun 2026
Expected to end
31 Jul 2029
Type of study
Interventional
Record updated
12 June 2026

Who can take part

AI summary

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

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Poland

Also in 4 other countries, 18 sites

  • Uniwersytecki Szpital Kliniczny w BialymstokuBialystok, PolandTaking people
  • Oculomedica Sp. z o.o.Bydgoszcz, PolandTaking people
  • OFTALMIKA Sp. z o.oBydgoszcz, PolandTaking people
  • Centrum Medyczne Dietla 19 Sp. z o.o.Cracow, PolandTaking people
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W KrakowieCracow, PolandTaking people
  • Profesorskie Centrum Medyczne Sp. z o.o.Gdansk, PolandTaking people
  • Gabinet Okulistyczny Prof Edward WylegalaKatowice, PolandTaking people
  • Centrum Diagnostyki i Mikrochirurgii Oka-Lens Sp. z o.o.Olsztyn, PolandTaking people
  • Caminomed Sp. z o.o.Tarnowskie Góry, PolandTaking people
  • Warszawski Szpital Okulistyczny Sp. z o.o.Warsaw, PolandTaking people

About the trial

What the trial wants to find out

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official 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 compared to aflibercept (2 mg) in participants with neovascular age-related macular degeneration (NVAMD)
Plain-language title
Tests EYE201 eye injection against aflibercept in wet age-related macular degenerationGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
12 June 2026