Phase 2/3 study to evaluate efficacy & safety of MK-8748 in patients with NVAMD
Research type
Research Study
Full 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)
IRAS ID
1013341
Contact name
Divya Manek
Contact email
Sponsor organisation
Eyebiotech Limited
Clinicaltrials.gov Identifier
Research summary
Neovascular age-related macular degeneration (NVAMD) is the leading cause of severe vision loss in people over 50 and central vision loss in those over 65. NVAMD is an eye condition where abnormal blood vessels grow under the retina (the light-sensitive layer at the back of the eye). These new and abnormal bloods vessels leak fluid or blood, damaging the macula - the part of the eye responsible for sharp, straight-ahead vision. People with NVAMD may notice blurry or wavy vision, dark spots, or difficulty seeing details. If left untreated, NVAMD can lead to serious and permanent loss of central vision.
Current treatments mostly involve medicines called anti-VEGF drugs, which help block the growth of the abnormal blood vessels. These treatments can preserve vision for some people, but they don’t work well enough for everyone, so there is still a need for better options that improve results.
This study is testing a new medicine called EYE201/MK 8748 (also called Tiespectus) to see if it can safely treat NVAMD as well as the current standard anti-VEGF treatment, aflibercept. Tiespectus is designed to strengthen blood vessels and reduce leakage, while also blocking the growth of abnormal vessels. Both are given by an injection into the eye (intravitreal injection).
About 960 participants aged 50 or older with newly diagnosed NVAMD will take part. Participants will be randomly placed into one of three groups (two dose levels of Tiespectus or aflibercept) and will be in the study for up to 96 weeks.REC name
London - Harrow Research Ethics Committee
REC reference
26/LO/0054
Date of REC Opinion
27 Mar 2026
REC opinion
Further Information Favourable Opinion