FARICIMAB for Polypoidal choroidal vasculopathy

Inclusion criteria

• {"criterion_text":"- Signed informed consent form (ICF)\n- Age ≥ 50 years at the time of signing the ICF\n- Caucasian\n- Participants who are able to comply with the study protocol, in the investigator’s judgment\n- For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception\n- Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis.\n- 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.\n- 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

• {"criterion_text":"- 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.\n- Any major illness or major surgical procedure within 1 month before screening.\n- 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.\n- 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).\n- Systemic treatment for suspected or active systemic infection on study Day 1.\n- Ongoing use of prophylactic antibiotic therapy may be acceptable after discussion with the Medical Monitor.\n- 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.\n- History of stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to study Day 1.\n- 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.\n- 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.\n- Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 3 months after the final dose of faricimab.\n- History of idiopathic or autoimmune-associated uveitis in either eye.\n- Active ocular inflammation or suspected or active ocular or periocular infection in either eye on study Day 1.\n- Any history or presence of macular pathology unrelated to PCV affecting vision or contributing to the presence of macular haemorrhage, IRF, or SRF.\n- Retinal pigment epithelial tear involving the macula on study Day 1.\n- 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.\n- 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.\n- 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.\n- 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.\n- Any other intraocular surgery (e.g., pars plana vitrectomy, glaucoma surgery, corneal transplant, or radiotherapy).\n- Prior periocular pharmacological or IVT treatment (including anti-VEGF medication) for other retinal diseases.\n- 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.\n- 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."}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"BCVA measured on the ETDRS chart at a starting distance of 4 meters; change from baseline assessed at Weeks 40, 44 or 48."}

Secondary endpoints

• {"endpoint_text":"- Change from baseline in BCVA (as measured on the ETDRS chart at a starting distance of 4 meters) to the last treatment visit.","definition_or_measurement_approach":"BCVA measured on ETDRS chart at 4 meters; change from baseline to last treatment visit."}
• {"endpoint_text":"- Change from baseline in BCVA over time.","definition_or_measurement_approach":"Serial BCVA measurements using ETDRS chart at 4 meters over study visits."}
• {"endpoint_text":"- Proportion of participants gaining ≥ 15, ≥ 10, or ≥ 5 letters in BCVA from baseline over time.","definition_or_measurement_approach":"Proportion achieving specified letter gains on ETDRS chart versus baseline across visits."}
• {"endpoint_text":"- Proportion of participants avoiding loss of ≥ 15, ≥ 10, ≥ 5 letters in BCVA from baseline over time.","definition_or_measurement_approach":"Proportion not losing the specified number of ETDRS letters from baseline across visits."}
• {"endpoint_text":"- Percentage of participants maintaining or achieving BCVA of 20/40 (69 letters).","definition_or_measurement_approach":"Proportion with BCVA ≥ 69 ETDRS letters (approx. 20/40) at specified visits."}
• {"endpoint_text":"- Proportion of participants with complete polypoidal lesion regressions at Weeks 40, 44, or 48 and at the end of the study","definition_or_measurement_approach":"Assessment of polypoidal lesion regression by imaging (ICGA) at Weeks 40, 44 or 48 and study end."}
• {"endpoint_text":"- Change from baseline in central subfield thickness (CST) at Weeks 40, 44 or 48.","definition_or_measurement_approach":"CST measured by OCT; change from baseline at Weeks 40, 44 or 48."}
• {"endpoint_text":"- Change from baseline in CST to the end of the study.","definition_or_measurement_approach":"CST measured by OCT; change from baseline to study end."}
• {"endpoint_text":"- Change from baseline in CST over time.","definition_or_measurement_approach":"Serial OCT-measured CST changes over study visits."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"OCT assessment for absence of intraretinal and subretinal fluid at specified visits."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"OCT assessment for absence of intraretinal, subretinal and sub-RPE fluid at specified visits."}
• {"endpoint_text":"- Change from baseline in branch neovascular network size at 1 and 2 years.","definition_or_measurement_approach":"Measurement of neovascular network size (imaging) compared with baseline at 1 and 2 years."}
• {"endpoint_text":"- Proportion of participants on 12 weeks or more treatment intervals at the end of the study.","definition_or_measurement_approach":"Proportion of participants whose treatment interval reached ≥12 weeks by study end (treat-and-extend schedule)."}
• {"endpoint_text":"- Number of faricimab injections received from Week 20 until the end of the study.","definition_or_measurement_approach":"Count of administered intravitreal faricimab injections from Week 20 to study end."}
• {"endpoint_text":"- Incidence and severity of ocular adverse events (AE).","definition_or_measurement_approach":"Recording and grading of ocular AEs per protocol safety reporting procedures."}
• {"endpoint_text":"- Incidence and severity of non-ocular AEs.","definition_or_measurement_approach":"Recording and grading of non-ocular AEs per protocol safety reporting procedures."}

Italy

Earliest CTIS Part Ii Submission Date

22-05-2025

Latest Decision Or Authorization Date

25-06-2025

Processing Time Days

34

Number Of Sites

7

Number Of Participants

30

Spain

Earliest CTIS Part Ii Submission Date

12-06-2025

Latest Decision Or Authorization Date

26-06-2025

Processing Time Days

14

Number Of Sites

8

Number Of Participants

34

Portugal

Earliest CTIS Part Ii Submission Date

09-05-2025

Latest Decision Or Authorization Date

23-06-2025

Processing Time Days

45

Number Of Sites

10

Number Of Participants

26

Primary sponsor

Full Name

Association For Innovation And Biomedical Research On Light And Image

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Portugal

Third parties

• {"country":"Italy","full_name":"Opis S.r.l.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Liverpool University Hospitals NHS Foundation Trust","duties_or_roles":"Ophthalmic images reading centre","organisation_type":"Hospital/Clinic/Other health care facility"}