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

Phase 4

Not yet recruiting

• Conditions: polypoidal choroidal vasculopathy

• Registration Number: 2024-515640-22-00
• Lead Sponsor: Association For Innovation And Biomedical Research On Light And Image

Brief Summary

To evaluate the efficacy of intravitreal (IVT) injections of faricimab on Best Corrected Visual Acuity (BCVA) outcomes in caucasian patients with symptomatic macular polypoidal choroidal vasculopathy (PCV)

Detailed Description

Not available

Study Timeline

• Study First Posted: 2025-06-23
• Last Update Posted: 2025-06-26

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 90

Inclusion Criteria

General Inclusion Criteria: Potential participants are eligible to be included in the study only if all of the following criteria apply: - Signed informed consent form (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.

Ocular Inclusion Criteria for study eye: - Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis. - Confirmed diagnosis, by the Reading Centre, of naïve symptomatic macular PCV defined by the following: Active macular polypoidal lesions shown by ICGA AND Presence of exudative or haemorrhagic features involving the macula as identified by the investigator using multimodal images. - BCVA scores of 78-24 ETDRS letters, inclusive (20/32 to 20/320 approximate Snellen equivalent), using the ETDRS protocol and assessed at the initial testing distance of 4 meters on study Day 1.

Exclusion Criteria

General Exclusion Criteria: 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 of the following medications and treatments: Systemic anti-VEGF therapy, Systemic drugs known to cause macular oedema (fingolimod, tamoxifen), Other experimental therapies (except those comprising vitamins and minerals) and therapies that claim to have an effect on macular pathology (e.g., kallidinogenase). - Systemic treatment for suspected or active systemic infection on study Day 1. - Ongoing use of prophylactic antibiotic therapy may be acceptable after discussion with the Medical Monitor. - Uncontrolled blood pressure, defined as systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg while the participant is at rest on study Day 1. - History of stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to study Day 1. - History of other diseases, metabolic dysfunction, physical examination finding, or historical or current clinical laboratory findings giving reasonable suspicion of a condition that contraindicates the use of the IMP or that might affect the interpretation of the results of the study or renders the participant at high risk for treatment complications in the opinion of the investigator. - History of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the faricimab injection, study-related procedure preparations (including fluorescein and indocyanine green dyes), dilating drops, or any of the anaesthetic and antimicrobial preparations used by a participant during the study. - Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 3 months after the final dose of faricimab.

Ocular Exclusion Criteria: Potential participants are excluded from the study if any of the following criteria apply to both eyes: - History of idiopathic or autoimmune-associated uveitis in either eye. - Active ocular inflammation or suspected or active ocular or periocular infection in either eye on study Day 1.

Ocular exclusion criteria for study eye: Participants who meet any of the following ocular criteria for the study eye will be excluded from study entry: - Any history or presence of macular pathology unrelated to PCV affecting vision or contributing to the presence of macular haemorrhage, IRF, or SRF. - Retinal pigment epithelial tear involving the macula on study Day 1. - Diagnosis with or suspected of having narrow-angle glaucoma who have not undergone iridotomy. The inclusion of these patients will be conditional upon prior referral to the relevant specialist for appropriate treatment to enable participation in the study. - On FFA/colour fundus photograph (CFP): Subretinal haemorrhage of > 4 macular photocoagulation study disc area and/or that involves the fovea; Fibrosis or atrophy of > 50% of the total lesion area and/or that involves the fovea; aculopathy, or epiretinal membrane with traction) Any concurrent intraocular condition (e.g., amblyopia, aphakia, retinal detachment, cataract, diabetic retinopathy or mthat, in the opinion of the investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the study; Current vitreous haemorrhage on study Day 1; Advanced and/or uncontrolled glaucoma; Spherical equivalent of refractive error demonstrating more than 8 dioptres of myopia. - Any prior or concomitant treatment for PCV or other retinal diseases, including, but not restricted to, IVT treatment (e.g., faricimab, anti-VEGF, steroids, tissue plasminogen activator, ocriplasmin, C3F8, air), periocular pharmacological intervention, argon laser photocoagulation, verteporfin PDT, diode laser, transpupillary thermotherapy, or ocular surgical intervention. - Any cataract surgery or treatment for complications of cataract surgery with steroids or yttrium-aluminum-garnet (YAG) laser capsulotomy within 3 months prior to study Day 1. - Any other intraocular surgery (e.g., pars plana vitrectomy, glaucoma surgery, corneal transplant, or radiotherapy). - Prior periocular pharmacological or IVT treatment (including anti-VEGF medication) for other retinal diseases. - Continuous use of any of the following medications and treatments: IVT anti-VEGF agents (other than study-assigned faricimab); IVT, periocular (subtenon) corticosteroids, steroid implants (i.e., Ozurdex®, Illuvien®), or chronic topical ocular corticosteroids (defined as continuous usage for 100 days or longer); Concurrent use of any macular photocoagulation or PDT with verteporfin.

Participants who have a non-functioning fellow (non-study) eye, defined as either BCVA of hand motion or worse, or no physical presence of non-study eye (i.e., monocular), at both the screening and study Day 1 visits will be excluded from study entry.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in BCVA (as measured on the Early Treatment of Diabetic Retinopathy Study [ETDRS] chart at a starting distance of 4 meters) at Weeks 40, 44 or 48.		Change from baseline in BCVA (as measured on the Early Treatment of Diabetic Retinopathy Study [ETDRS] chart at a starting distance of 4 meters) at Weeks 40, 44 or 48.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in BCVA (as measured on the ETDRS chart at a starting distance of 4 meters) to the last treatment visit.		Change from baseline in BCVA (as measured on the ETDRS chart at a starting distance of 4 meters) to the last treatment visit.
Change from baseline in BCVA over time.		Change from baseline in BCVA over time.
Proportion of participants gaining ≥ 15, ≥ 10, or ≥ 5 letters in BCVA from baseline over time.		Proportion of participants gaining ≥ 15, ≥ 10, or ≥ 5 letters in BCVA from baseline over time.
Proportion of participants avoiding loss of ≥ 15, ≥ 10, ≥ 5 letters in BCVA from baseline over time.		Proportion of participants avoiding loss of ≥ 15, ≥ 10, ≥ 5 letters in BCVA from baseline over time.
Percentage of participants maintaining or achieving BCVA of 20/40 (69 letters).		Percentage of participants maintaining or achieving BCVA of 20/40 (69 letters).
Proportion of participants with complete polypoidal lesion regressions at Weeks 40, 44, or 48 and at the end of the study		Proportion of participants with complete polypoidal lesion regressions at Weeks 40, 44, or 48 and at the end of the study
Change from baseline in central subfield thickness (CST) at Weeks 40, 44 or 48.		Change from baseline in central subfield thickness (CST) at Weeks 40, 44 or 48.
Change from baseline in CST to the end of the study.		Change from baseline in CST to the end of the study.
Change from baseline in CST over time.		Change from baseline in CST over time.
Proportion of participants with no intraretinal fluid and no subretinal fluid at Weeks 20, 40, 44, or 48 and at the end of the study.		Proportion of participants with no intraretinal fluid and no subretinal fluid at Weeks 20, 40, 44, or 48 and at the end of the study.
Proportion of participants with no intraretinal fluid, no subretinal fluid and no sub-RPE fluid at Weeks 20, 40, 44, or 48 and at the end of the study.		Proportion of participants with no intraretinal fluid, no subretinal fluid and no sub-RPE fluid at Weeks 20, 40, 44, or 48 and at the end of the study.
Change from baseline in branch neovascular network size at 1 and 2 years.		Change from baseline in branch neovascular network size at 1 and 2 years.
Proportion of participants on 12 weeks or more treatment intervals at the end of the study.		Proportion of participants on 12 weeks or more treatment intervals at the end of the study.
Number of faricimab injections received from Week 20 until the end of the study.		Number of faricimab injections received from Week 20 until the end of the study.
Incidence and severity of ocular adverse events (AE).		Incidence and severity of ocular adverse events (AE).
Incidence and severity of non-ocular AEs.		Incidence and severity of non-ocular AEs.

Trial Locations

Locations (25)

Ospedale San Raffaele S.r.l.; 🇮🇹 Milan, Italy

Universita' Degli Studi Di Udine; 🇮🇹 Udine, Italy

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico; 🇮🇹 Milan, Italy

ASST Fatebenefratelli Sacco; 🇮🇹 Milan, Italy

Multimedica S.p.A.; 🇮🇹 Milan, Italy

Azienda Ospedaliero-Universitaria Maggiore Della Carita; 🇮🇹 Novara, Italy

Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia; 🇮🇹 Rome, Italy

Unidade Local De Saude De Santo Antonio E.P.E.; 🇵🇹 Porto, Portugal

Unidade Local De Saude De Santa Maria E.P.E.; 🇵🇹 Lisbon, Portugal

Unidade Local De Saude De Loures-Odivelas EPE; 🇵🇹 Loures, Portugal

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Ospedale San Raffaele S.r.l.

🇮🇹Milan, Italy

Francesco Bandello

Site contact

00390226432648

bandello.francesco@hsr.it