Study to Investigate the Efficacy, Safety and Durability of Faricimab in Caucasian Patients With Polypoidal Choroidal Vasculopathy (MONDEGO)

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age50-90
SponsorAssociation for Innovation and Biomedical Research on Light and Image

About this trial

The goal of this clinical trial is to assess the efficacy, safety and durability of faricimab in caucasian patients with polypoidal choroidal vasculopathy (PCV). The main question it aims to answer is:

To evaluate the efficacy of intravitreal (IVT) injections of faricimab 6 milligrams (mg) on Best Corrected Visual Acuity (BCVA) outcomes in caucasian patients with symptomatic macular PCV.

Participants will undergo ophthalmic examination, safety assessment and treatment with faricimab according to a patient specific treat and extend regimen.

Eligibility criteria

Qualifiers

Signed ICF

Age ≥ 50 years at the time of signing the ICF

Caucasian

Participants who are able to comply with the study protocol, in the investigator's judgment

Disqualifiers

Treatment with investigational therapy (device, drug, or traditional medicine with the exception of vitamins and minerals) within 3 months prior to initiation of study treatment on study Day 1

Any major illness or major surgical procedure within 1 month before screening

Active cancer within the 12 months prior to study Day 1 except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer with a Gleason score of ≤ 6 (Grade Group of 1) and a stable prostate-specific antigen for ≥ 12 months

Systemic anti-VEGF therapy

Trial design

Treatments tested in this trial

  • Faricimab Injection [Vabysmo]

Treatment groups

120 Participants
are divided into 1 treatment group