A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-002)
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)
EyeBiotech Ltd.
960 participants
Mar 27, 2026
INTERVENTIONAL
Conditions
Summary
Researchers are looking for new ways to treat neovascular age-related macular degeneration (NVAMD). Available standard (usual) treatments for NVAMD, such as aflibercept, may not work for every person. Researchers want to learn if a trial medicine called tiespectus (also called MK-8748 or EYE201) can treat NVAMD. The goal of this trial is to learn if tiespectus works as well as aflibercept to treat NVAMD.
Eligibility
Inclusion Criteria2
- 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
Exclusion Criteria7
- Has uncontrolled blood pressure at screening
- History of any prior macular laser photocoagulation in the study eye
- History of uveitis in either 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 uncontrolled glaucoma in the study eye
- Active retinal disease other than the condition under investigation in the study eye
- Has previously received anti- vascular endothelial growth factor (VEGF) therapy or other intravitreal (IVT) therapy in the study eye
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Interventions
Administered by intravitreal (IVT) injection
Administered by intravitreal injection (IVT)
Locations(91)
View Full Details on ClinicalTrials.gov
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NCT07440225