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Taking people in ItalyPhase 2/3

Tests EYE201/MK-8748 eye injection against aflibercept in wet macular degeneration

Tests an eye injection, EYE201/MK-8748, compared with aflibercept in adults with wet macular degeneration.

Key facts

Who runs it
Eyebiotech Limited
Where
Ferrara, Florence, Milan, Rome, Turin, and Udine, ItalySee the 10 sitesAlso in 9 other countries, 45 sites
Trial code
Registry title
A clinical trial of EYE201/MK-8748 in people with macular degeneration (MK-8748-003)
Status
Recruiting
Phase
Phase 2/3
People taking part
250 people, planned
Started
22 Jun 2026
Expected to end
30 Aug 2029
Type of study
Interventional
Record updated
10 September 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 had treatment in the affected eye.

Age
18 years or older
Sex
All sexes can join
Disease stage
Treatment-naive choroidal neovascularization due to age-related macular degeneration in at least one eye, diagnosed within 21 days before starting treatment. Vision loss must mainly come from NVAMD.
Earlier treatment
No earlier anti-VEGF or other intravitreal treatment in the study eye. No earlier macular laser treatment in the study eye.

Main reasons for not taking part

  • Uncontrolled blood pressure at screening
  • Uveitis in either eye in the past
  • Uncontrolled glaucoma in the study eye
  • Other active retinal disease in the study eye
  • Cataract surgery, glaucoma surgery or Yag laser capsulotomy in the study eye within 90 days before entering the study

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
  • Has 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 Italy

Also in 9 other countries, 45 sites

  • University Hospital Of FerraraFerrara, ItalyTaking people
  • Azienda Ospedaliero-Universitaria CareggiFlorence, ItalyTaking people
  • ASST Fatebenefratelli SaccoMilan, ItalyTaking people
  • Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, ItalyTaking people
  • Ospedale San Raffaele S.r.l.Milan, ItalyTaking people
  • Azienda Ospedaliera Policlinico Universitario Tor VergataRome, ItalyTaking people
  • Fondazione G.B.Bietti Per Lo Studio E La Ricerca In OftalmologiaRome, ItalyTaking people
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people
  • Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di TorinoTurin, ItalyTaking people
  • Azienda Sanitaria Universitaria Friuli CentraleUdine, ItalyTaking 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/MK-8748 eye injection against aflibercept in wet 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
10 September 2026