Study to Investigate the Efficacy, Safety and Durability of Faricimab in Caucasian Patients With … (NCT06709339) | Clinical Trial Compass
RecruitingPhase 4
Study to Investigate the Efficacy, Safety and Durability of Faricimab in Caucasian Patients With Polypoidal Choroidal Vasculopathy (MONDEGO)
Italy120 participantsStarted 2025-08-06
Plain-language summary
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.
Who can participate
Age range50 Years – 90 Years
SexALL
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General Inclusion Criteria:
Potential participants are eligible to be included in the study only if all of the following criteria apply:
* 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
* For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception as defined below:
Female participants must remain abstinent or use contraceptive methods with a failure rate of \< 1% per year, during the treatment period and for at least 3 months after the final dose of faricimab.
A female participant is considered to be of childbearing potential if she is post-menarche, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). Per this definition, a female participant with a tubal ligation is considered to be of childbearing potential. The definition of childbearing potential may be adapted for alignment with local guidelines or regulations.
Examples of contraceptive methods with a failure rate of \< 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine dev…
What they're measuring
1
Change from Baseline in BCVA in the study eye to Week 40 or 44 or 48
Timeframe: From Baseline through Week 40 or 44 or 48
Trial details
NCT IDNCT06709339
SponsorAssociation for Innovation and Biomedical Research on Light and Image