LUCIA
Research type
Research Study
Full title
A Phase 3, Multicenter, Prospective, Randomized, Double-Masked, Parallel-Group Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept in Subjects with Wet AMD
IRAS ID
1011610
Contact name
Ruth Paul
Contact email
Sponsor organisation
EyePoint Pharmaceuticals, Inc.
Clinicaltrials.gov Identifier
Research summary
The study is looking for an alternate treatment that may help people with wet age-related macular degeneration (wet AMD). Wet AMD is a long-lasting eye disorder that can cause blurring or a blind spot in the central vision.
People with wet AMD often experience the challenge of frequent treatment, with injections inside the eye (intravitreal injections). EYP-1901 is being developed to block the mechanism responsible for fluid leaks in the macula, while potentially reducing the number of injections needed over time. Aflibercept is an approved medicine for the treatment of wet AMD.
The purpose of this study is to find out how EYP-1901 may help treat wet AMD compared to aflibercept. This study also aims to learn about the efficacy and safety of EYP-1901 compared to aflibercept in treating wet AMD.
This is a randomized, multicenter study where participants will be in the study for about 99 weeks. This is a double-masked study, the study doctors and participants will not know which treatment participants will receive.
At least 50 years old adults diagnosed with wet AMD can participate in the study, in 165 sites globally.
Participants will be randomly divided into 2 groups:
• EYP-1901 group: In this group they will receive aflibercept IVT on Day 1 and Week 4. On Week 8, they will receive aflibercept and EYP-1901 IVT. They will then continue to receive EYP-1901 IVT every 24 weeks throughout the study. Sometimes, participants in this group will also receive a sham injection. Sham injection mimics and feels like a real eye injection, but it does not penetrate the eye, nor contain any medicine.
• Aflibercept group: In this group they will receive aflibercept IVT on Day 1 and Week 4. On Week 8, they will receive aflibercept IVT and sham injection. After Week 8, they will receive aflibercept every 8 weeks.
During the visits, the site staff will collect information and regularly perform tests on participants’ eye health and take blood samples.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
25/SC/0095
Date of REC Opinion
12 May 2025
REC opinion
Further Information Favourable Opinion