Study to investigate efficacy, safety and durability of faricimab in caucasian patients with PCV
Research type
Research Study
Full title
A phase IV, multicentre, open-label, single-arm study to investigate the efficacy, safety and durability of faricimab (RO6867461) in caucasian patients with polypoidal choroidal vasculopathy (acronym: MONDEGO)
IRAS ID
1011335
Contact name
Joana Tavares
Contact email
Sponsor organisation
AIBILI - Association for Innovation and Biomedical Research on Light and Image
ISRCTN Number
-
Clinicaltrials.gov Identifier
Research summary
The MONDEGO clinical trial is studying a recent approved treatment called faricimab for Age-related macular degeneration (AMD) patients in a group of Caucasian patients with a specific type of AMD known as polypoidal choroidal vasculopathy (PCV). This trial’s main goal is to find out if faricimab, given through eye injections, helps improve and sustain that improvement for higher intervals between injections and ensures safety for patients suffering from this eye disease.
AMD is a common cause of vision loss in older adults. It can develop slowly and lead to serious eyesight problems over time. PCV is a specific type of AMD that can cause further complications. Currently, patients receive injections to manage PCV, but these treatments can be challenging. Patients may need many injections, and sometimes the problem doesn’t fully go away, which makes finding better treatments very important.
In the MONDEGO trial, patients will receive faricimab injections for about 24 months. Each participant will have regular eye check-ups and safety assessments, which will help doctors understand how well the treatment is working. The number of visits can range from 12 to 18, depending on how each patient responds to the treatment. After the last injection, participants will have a final visit about four weeks later to compare their vision with their condition before starting treatment.
The trial will take place in around 30 clinical sites across four European countries: Portugal, Spain, Italy, and the United Kingdom. The study aims to include about 120 participants. This research will not only help determine if faricimab is effective but also contribute to future treatments and prevention of vision loss for people with PCV.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
25/NW/0096
Date of REC Opinion
9 May 2025
REC opinion
Further Information Favourable Opinion