Phase 4: testing Faricimab Injection [Vabysmo] for Polypoidal Choroidal Vasculopathy
The goal of this clinical trial is to assess the how well it works, safety and durability of faricimab in caucasian patients with polypoidal choroidal vasculopathy (PCV). The main question it aims to answer is: To measure the how well it works of intravitreal (IVT) injections of faricimab 6 milligrams (mg) on Best Corrected Visual Acuity (BCVA) outcomes in caucasian patients with symptomatic macular PCV.
Official registry: https://clinicaltrials.gov/study/NCT06709339 · Association for Innovation and Biomedical Research on Light and Image · enrollment listed as 120
What this phase means
Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Faricimab Injection [Vabysmo]. The registry lists allocation as na. The goal of this clinical trial is to assess the how well it works, safety and durability of faricimab in caucasian patients with polypoidal choroidal vasculopathy (PCV).
They plan to enroll about 120 people at 30 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
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
Interventions: Faricimab Injection [Vabysmo]
Primary outcome (registry wording): Change from Baseline in BCVA in the study eye to Week 40 or 44 or 48
Who it is for (from inclusion criteria)
- Ages 50 Years to 90 Years
- Potential participants are eligible to be included in the study only if all of the following criteria apply:
- Age ≥ 50 years at the time of signing the ICF
- 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
- 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 devices, and copper intrauterine devices
- The reliability of sexual abstinence should be evaluated concerning the duration of the clinical trial and the preferred and usual lifestyle of the individual
Who the registry excludes
- Potential participants are excluded from the study if any of the following criteria apply:
- 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
- Continuous use of any medications and treatments indicated below:
- Systemic anti-VEGF therapy
- Systemic drugs known to cause macular oedema (fingolimod, tamoxifen)
Public study contact (from the registry)
Joana F Tavares, PhD
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
30 listed- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena — Milan, Italy (not_yet_recruiting)
- Medical Retina Service, Operative Unit Ophthalmology - MultiMedica Spa (IRCCSMM) — Milan, Italy (not_yet_recruiting)
- ASST-Fatebenefratelli-Sacco P.O.L. Sacco — Milan, Italy (not_yet_recruiting)
- Eye Unit, University Hospital Maggiore della Carità — Novara, Italy (not_yet_recruiting)
- IRCCS Fondazione G.B. Bietti per lo Studio e la Ricerca in Oftalmologia ONLUS, — Roma, Italy (recruiting)
- Department of Ophthalmology, University Vita Salute - Scientific Institute of San Raffaele — San Raffaele, Italy (not_yet_recruiting)
- Department of Ophthalmology, University of Udine — Udine, Italy (not_yet_recruiting)
- Espaço Médico de Coimbra — Coimbra, Portugal (recruiting)
- Ophthalmology Department, Hospitais Universidade de Coimbra, — Coimbra, Portugal (recruiting)
- Unidade Local de Saúde da Região de Leiria, E.P.E. — Leiria, Portugal (recruiting)
- almPRIMUM- Serviços de Oftalmologia Médica e Cirúrgica — Lisbon, Portugal (recruiting)
- Instituto de Retina e Diabetes Ocular de Lisboa (IRL), — Lisbon, Portugal (recruiting)
FAQ about this NCT record
Is NCT06709339 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06709339?
Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06709339?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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