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
- Bialystok, Bydgoszcz, Cracow, Gdansk, Katowice, Olsztyn, Tarnowskie Góry és Warsaw, LengyelországSee the 10 sites
- Phase
- 2/3. fázis
Where in Lengyelország
- Uniwersytecki Szpital Kliniczny w BialymstokuBialystok, LengyelországTaking people
- Oculomedica Sp. z o.o.Bydgoszcz, LengyelországTaking people
- OFTALMIKA Sp. z o.oBydgoszcz, LengyelországTaking people
- Centrum Medyczne Dietla 19 Sp. z o.o.Cracow, LengyelországTaking people
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W KrakowieCracow, LengyelországTaking people
- Profesorskie Centrum Medyczne Sp. z o.o.Gdansk, LengyelországTaking people
- Gabinet Okulistyczny Prof Edward WylegalaKatowice, LengyelországTaking people
- Centrum Diagnostyki i Mikrochirurgii Oka-Lens Sp. z o.o.Olsztyn, LengyelországTaking people
- Caminomed Sp. z o.o.Tarnowskie Góry, LengyelországTaking people
- Warszawski Szpital Okulistyczny Sp. z o.o.Warsaw, LengyelországTaking 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?
Trial details
- Who runs it
- Eyebiotech Limited
- Trial code
- EU 2025-524575-22-00
- Record updated
- 2026. június 12.
- 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.