What is faricimab studying for polypoidal choroidal vasculopathy?

Faricimab is being studied to evaluate its effects on vision improvement and safety in Caucasian patients with symptomatic macular PCV. The trial aims to understand how faricimab injections impact best corrected visual acuity and disease activity over time, supported by the Association for Innovation and Biomedical Research on Light and Image.

Who may be eligible for this polypoidal choroidal vasculopathy clinical trial?

Adults aged 50 to 90 years who are Caucasian with a confirmed diagnosis of symptomatic macular PCV may be eligible. Participants must have no prior treatment for PCV in the study eye and be able to follow study procedures. Please review eligibility criteria for more details.

Is there any cost to participate in this polypoidal choroidal vasculopathy clinical trial?

Study-related care, including the study drug faricimab and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 4

Age: 50Years - 90Years

All Genders

ID06709339

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

Led by Association for Innovation and Biomedical Research on Light and Image · Updated on 2026-02-06

120

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness, safety, and lasting effects of faricimab in Caucasian patients with symptomatic macular polypoidal choroidal vasculopathy PCV. PCV is a type of choroidal vasculopathy that causes hemorrhagic and exudative macular degeneration. This study aims to see how intravitreal injections of faricimab 6 mg affect best corrected visual acuity BCVA outcomes in these patients, addressing the current unmet needs due to disease heterogeneity and treatment challenges. The study involves administering faricimab injections directly into the eye following a treat and extend regimen tailored to each patient. It is an open-label, single-arm study lasting approximately 100 weeks, including a screening period of up to 28 days, a 12-week treatment initiation period, and a subsequent treat and extend phase extending to week 100. Participants receive faricimab at intervals up to 24 weeks based on their response and the study protocol. Participants will undergo regular eye examinations, safety assessments, and visual acuity testing using the ETDRS protocol. The study will monitor changes in BCVA from baseline through weeks 40, 44, 48, and up to 104 weeks, along with imaging to assess polypoidal lesion regression and retinal thickness. Adverse events will be tracked throughout the study. Overall participation spans more than two years, allowing detailed evaluation of faricimabs effects on vision and eye health in this population.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 50Years - 90Years

All Genders

Eligibility Criteria

You may qualify if you...

Signed informed consent form
Age 50 years or older at the time of signing the consent
Caucasian ethnicity
Ability to follow the study protocol as judged by the investigator
For females of childbearing potential: agreement to remain abstinent or use effective contraception with less than 1% failure rate during treatment and for 3 months after last dose
Clear ocular media and adequate pupil dilation to obtain good quality retinal images
Confirmed diagnosis of treatment-naive symptomatic macular PCV by Reading Centre, including active macular polypoidal lesions and exudative or hemorrhagic features involving the macula
Best corrected visual acuity (BCVA) score between 24 and 78 ETDRS letters inclusive on study Day 1

You will not qualify if you...

Treatment with any investigational therapy within 3 months before study Day 1
Major illness or surgery within 1 month before screening
Active cancer within 12 months before study Day 1, except treated carcinoma in situ of cervix, non-melanoma skin cancer, or stable prostate cancer with low Gleason score
Continuous use of systemic anti-VEGF therapy or drugs known to cause macular edema
Active or suspected systemic infection on study Day 1
Uncontrolled blood pressure above 180/100 mmHg at rest on study Day 1
Stroke or heart attack within 6 months prior to study Day 1
Severe allergic reaction or known hypersensitivity to faricimab or related substances
Pregnancy, breastfeeding, or intention to become pregnant during study or within 28 days after last dose
History of uveitis or ocular inflammation in either eye
Active ocular or periocular infection on study Day 1
Macular pathology unrelated to PCV affecting vision in study eye
Retinal pigment epithelial tear involving macula
Narrow-angle glaucoma without iridotomy unless treated prior to study
Large subretinal hemorrhage, fibrosis, or atrophy involving the fovea
Other eye conditions that could reduce visual improvement or require surgery during study
Prior or concurrent treatment for PCV or other retinal diseases in study eye
Recent cataract surgery or complications within 3 months before study Day 1
Other intraocular surgeries
Use of IVT anti-VEGF agents other than study drug, steroid implants, or chronic topical corticosteroids
Use of macular photocoagulation or photodynamic therapy with verteporfin
Non-functioning fellow eye or monocular status at screening and study Day 1

Research Team

Joana F Tavares, PhD

Liliana C Soares, MsC

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