A Phase 4 interventional study of Faricimab Injection [Vabysmo] in Polypoidal Choroidal Vasculopathy, sponsored by Association for Innovation and Biomedical Research on Light and Image. Recruiting at 31 sites in 4 countries. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-02-06.
Sponsored by Association for Innovation and Biomedical Research on Light and Image · Phase 4, Interventional, and Treatment
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.
Polypoidal choroidal vasculopathy (PCV) was first described in 1982 by Yannuzzi as a choroidal vasculopathy leading to haemorrhagic and exudative macular degeneration. More than four decades later, the pathogenesis of the disease remains uncertain with authors considering PCV a subtype of neovascular age-related macular degeneration (nAMD) while others advocate a separate clinical entity and adequate treatment is still an unmet need.
Several studies have reported an association between PCV and major and minor interethnic classification differences regarding morphological alterations, prevalence, genetic associations, lesion location, and results after anti-vascular endothelial growth factor (VEGF) treatment, among others. For instance, the reported prevalence of PCV in patients with neovascular AMD ranges from 4% to 9,8% in Caucasians and from 22% to 55% in Asians. However, a recent study reported a much higher prevalence in Caucasians (22,1%), suggesting that PCV may actually be underdiagnosed in this population.
Today, intravitreal (IVT) anti-VEGF therapy plays a key role in the management of PCV and has become the standard of care. The anti-permeability property of anti-VEGF agents, such as aflibercept and ranibizumab, play a role in reducing the exudation from abnormal choroidal vessels and polypoidal lesions, thereby decreasing the subretinal fluid and preserving vision.
Although the current standard of care has demonstrated clinical benefit for patients with PCV, many limitations exist in understanding the disease as a result of its heterogeneity in clinical features and treatment outcomes. The burden of frequent injections, incomplete polypoidal lesion closure, and the risk and unpredictability of lesion relapse reinforce the need to develop new treatments for patients with PCV. This population is at risk of disease relapse, retinal haemorrhage, and vision loss, and is appropriate for inclusion in this clinical trial.
Faricimab is a novel humanized bispecific Immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds with high affinity to VEGF-A and angiopoietin-2 (Ang-2). Faricimab was studied for the treatment of neovascular AMD (nAMD) in the global Phase III Studies TENAYA (ClinicalTrials.gov identifier: NCT03823287) and LUCERNE (ClinicalTrials.gov identifier: NCT03823300) and is currently being studied in the long-term extension Study AVONELLE-X (ClinicalTrials.gov identifier: NCT04777201). The TENAYA (ClinicalTrials.gov identifier: NCT03823287) and LUCERNE (ClinicalTrials.gov identifier: NCT03823300) studies consistently showed that faricimab, given at intervals of up to 16 weeks, offered non-inferior vision gains compared with aflibercept, given every 2 months in the first year. Approximately 50% of participants eligible for extended dosing with faricimab were able to be treated every 4 months, and nearly 80% of participants every 3 months or longer. However, patients with symptomatic macular PCV were under-represented in the faricimab Phase III pivotal Studies TENAYA (ClinicalTrials.gov identifier: NCT03823287) and LUCERNE (ClinicalTrials.gov identifier: NCT03823300).
The purpose of this study is to assess the efficacy, durability, and safety of faricimab 6 mg IVT administered at up to 24-week intervals in the treatment-naive study eye of Caucasian patients with symptomatic macular PCV. This study will add to the evidence base for the benefit-risk profile of faricimab IVT injection in Caucasian patients with symptomatic macular PCV.
The study consists of a screening period of up to 28 days (Days -28 to -1) in length and an approximately 100-week study treatment period consisting of a Treatment Initiation period (Weeks 1-12) and the treat and extend (T\&E) regimen period (Weeks 20-Week 100).
54 studies on the registry are indexed under Polypoidal Choroidal Vasculopathy; 6 are open to participants now.
This study's planned enrollment of 120 is above the median of 50 across 39 interventional studies indexed under Polypoidal Choroidal Vasculopathy.
Browse Polypoidal Choroidal Vasculopathy studies →Association for Innovation and Biomedical Research on Light and Image is the lead sponsor of 38 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
General Inclusion Criteria:
Potential participants are eligible to be included in the study only if all of the following criteria apply:
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 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 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.
Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not adequate methods of contraception.
If required per local guidelines or regulations, locally recognized adequate methods of contraception and information about the reliability of abstinence will be described in the local ICF.
Ocular Inclusion Criteria for study eye:
Confirmed diagnosis, by the Reading Centre, of naïve symptomatic macular PCV defined by the following:
General Exclusion Criteria
Potential participants are excluded from the study if any of the following criteria apply:
Continuous use of any medications and treatments indicated below:
Ocular Exclusion Criteria
Potential participants are excluded from the study if any of the following criteria apply to both eyes:
Participants who meet any of the following ocular criteria for the study eye will be excluded from study entry:
On FFA/colour fundus photograph (CFP):
Continuous use of any medications and treatments indicated below:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This open-label, single-arm study will evaluate the efficacy, safety, and durability of Faricimab Injection \[Vabysmo\] 6 mg anti-VEGF IVT in Caucasian patients with symptomatic macular PCV.
Drug: Faricimab Injection [Vabysmo]
The investigational medicinal product (IMP) for this study is faricimab (RO6867461), as per clinical practice. No control treatment will be used for this study
Change from Baseline in BCVA in the study eye to Week 40 or 44 or 48
Best Corrected Visual Acuity (BCVA) is measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity.
Time frame: From Baseline through Week 40 or 44 or 48
Change from Baseline in BCVA in the Study
Best Corrected Visual Acuity (BCVA) is measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart
Time frame: From baseline through last treatment visit (up to 100 weeks)
Change from Baseline in BCVA in the Study Eye to the last treatment visit
At a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity.
Time frame: From Baseline through last treatment visit (up to 100 weeks)
Change From Baseline in BCVA in the Study Eye Over Time
Best Corrected Visual Acuity (BCVA) is measured on the ETDRS chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity.
Time frame: Over time (up to 104 weeks)
Proportion of Participants Gaining Greater Than or Equal to (≥)15, ≥10, or ≥5 Letters from the Baseline BCVA in the Study Eye Averaged Over Time
Best Corrected Visual Acuity (BCVA) is measured on the ETDRS chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity.
Time frame: Over time (up to 104 weeks)
Proportion of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters from the Baseline BCVA in the Study Eye Over Time
Best Corrected Visual Acuity (BCVA) is measured on the ETDRS chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score) and avoiding a loss in BCVA from baseline indicates no worsening in visual acuity.
Time frame: Over time (up to 104 weeks)
Percentage of Participants Maintaining or Achieving BCVA Snellen Equivalent of 20/40 (BCVA =69 Letters) in the Study Eye
Best Corrected Visual Acuity (BCVA) was measured on the ETDRS chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.
Time frame: Over time (up to 104 weeks)
Proportion of participants with complete polypoidal lesion regressions at Weeks 40, 44, or 48
Complete polypoidal lesions regressions are measured using Indocyanine Green Angiography (ICGA), as assessed by the central reading center.
Time frame: From Baseline through Week 40 or 44 or 48
Proportion of participants with complete polypoidal lesion regressions at the end of the study
Complete polypoidal lesions regressions are measured using Indocyanine Green Angiography (ICGA), as assessed by the central reading center.
Time frame: From Baseline through the end of the study (up to 104 weeks)
Change From Baseline in Central Subfield Thickness in the Study Eye at Weeks 40 or 44, or 48
Central subfield thickness (CST) is defined as the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE) using optical coherence tomography (OCT), as assessed by the central reading center.
Time frame: From Baseline through Week 40 or 44 or 48
Change from Baseline in Central Subfield Thickness in the Study Eye to the end of the study
Central subfield thickness (CST) is defined as the distance between the ILM and the RPE using OCT, as assessed by the central reading center.
Time frame: From Baseline through the end of the study (up to 104 weeks)
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time
Central subfield thickness (CST) is defined as the distance between the ILM and the RPE using OCT, as assessed by the central reading center.
Time frame: Over time (up to 104 weeks)
Proportion of Participants With no Intraretinal Fluid and no subretinal fluid in the Study Eye at Week 20
Intraretinal fluid and subretinal fluid are measured using OCT in the central subfield (center 1 millimetre \[mm\]).
Time frame: From Baseline and Week 20
Proportion of Participants With no Intraretinal Fluid and no subretinal fluid in the Study Eye at Weeks 40 or 44, or 48
Intraretinal fluid and subretinal fluid are measured using OCT in the central subfield (center 1 mm).
Time frame: From Baseline and Week 40 or 44 or 48
Proportion of Participants With no Intraretinal Fluid and no subretinal fluid in the Study Eye at the end of the study
Intraretinal fluid and subretinal fluid are measured using OCT in the central subfield (center 1 mm).
Time frame: From Baseline and the end of the study (up to 104 weeks)
Proportion of Participants With no Intraretinal Fluid, no Subretinal Fluid and no sub-RPE fluid in the Study Eye at Week 20
Intraretinal fluid, subretinal fluid and sub-RPE fluid are measured using OCT in the central subfield (center 1 mm).
Time frame: From Baseline and Week 20
Proportion of Participants With no Intraretinal Fluid, no Subretinal Fluid and no sub-RPE fluid in the Study Eye at Weeks 40 or 44, or 48
Intraretinal fluid, subretinal fluid and sub-RPE fluid are measured using OCT in the central subfield (center 1 mm).
Time frame: From Baseline and Week 40 or 44 or 48
Proportion of Participants With no Intraretinal Fluid, no Subretinal Fluid and no sub-RPE fluid in the Study Eye at the end of the study
Intraretinal fluid, subretinal fluid and sub-RPE fluid are measured using OCT in the central subfield (center 1 mm).
Time frame: From Baseline and the end of the study (up to 104 weeks)
Change From Baseline in branch Neovascularization network in the Study Eye at 1 year
The branch neovascularization network in the study eye is evaluated by a central reading center using OCT angiography (OCTA).
Time frame: Baseline and 1 year
Change From Baseline in branch Neovascularization network in the Study Eye at 2 years
The branch neovascularization network in the study eye is evaluated by a central reading center using OCT angiography (OCTA).
Time frame: Baseline and 2 years
Proportion of participants on 12 weeks or more treatment intervals at the end of the study.
Proportions are based on the number of participants who have not discontinued the study at the end of the study. The treatment interval at a given visit is defined as the treatment interval decision followed at that visit.
Time frame: End of study (up to 100 weeks)
Number of faricimab injections received from Week 20 until the end of the study.
Count of the number of faricimab injections each participant received after the treatment initiation period (baseline to week 12).
Time frame: Week 20 through end of study (up to 100 weeks)
Incidence and severity of ocular adverse events
This analysis of adverse events (AEs) only includes ocular AEs. Investigators sought information on AEs at each contact with the participants. All AEs are recorded and the investigator made an assessment of seriousness, severity, and causality of each AE.
Time frame: From first dose of study drug through end of study (up to 104 weeks)
Incidence and severity of Non-Ocular Adverse Event
This analysis of AEs only includes non-ocular (systemic) AEs. Multiple occurrences of the same AE in one individual are counted only once. Investigators sought information on AEs at each contact with the participants. All AEs were recorded and the investigator made an assessment of seriousness, severity, and causality of each AE.
Time frame: From first dose of study drug through end of study (up to 104 weeks)
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Studies of the drug tested here: Faricimab
Polypoidal Choroidal Vasculopathy →
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