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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Association For Innovation And Biomedical Research On Light And Image

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

6 Aug 2025 → ongoing

Decision date (initial)

2025-06-25

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

F. Hoffmann-La Roche Ltd

External identifiers

EU CT number

2024-515640-22-00

ClinicalTrials.gov

NCT06709339

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Others

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)

Secondary objectives 6

1. To evaluate the efficacy of IVT injections of faricimab on additional BCVA outcomes.
2. To evaluate the efficacy of IVT injections of faricimab on anatomic outcome measures using Indocyanine Green Angiography (ICGA).
3. To evaluate the efficacy of IVT injections of faricimab on anatomic outcomes measures using Optical Coherence Tomography (OCT).
4. To evaluate the efficacy of IVT injections of faricimab on anatomic outcomes measures using Optical Coherence Tomography Angiography (OCTA).
5. To evaluate the durability of IVT injections of faricimab.
6. To evaluate the ocular and non-ocular safety and tolerability of IVT injections of faricimab.

Conditions and MedDRA coding

polypoidal choroidal vasculopathy

Study design 2 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. 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.
2. 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 4

1. 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.
2. 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.
3. 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.
4. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 16

1. Change from baseline in BCVA (as measured on the ETDRS chart at a starting distance of 4 meters) to the last treatment visit.
2. Change from baseline in BCVA over time.
3. Proportion of participants gaining ≥ 15, ≥ 10, or ≥ 5 letters in BCVA from baseline over time.
4. Proportion of participants avoiding loss of ≥ 15, ≥ 10, ≥ 5 letters in BCVA from baseline over time.
5. Percentage of participants maintaining or achieving BCVA of 20/40 (69 letters).
6. Proportion of participants with complete polypoidal lesion regressions at Weeks 40, 44, or 48 and at the end of the study
7. Change from baseline in central subfield thickness (CST) at Weeks 40, 44 or 48.
8. Change from baseline in CST to the end of the study.
9. Change from baseline in CST over time.
10. 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.
11. 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.
12. Change from baseline in branch neovascular network size at 1 and 2 years.
13. Proportion of participants on 12 weeks or more treatment intervals at the end of the study.
14. Number of faricimab injections received from Week 20 until the end of the study.
15. Incidence and severity of ocular adverse events (AE).
16. Incidence and severity of non-ocular AEs.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Association For Innovation And Biomedical Research On Light And Image

Sponsor organisation

Association For Innovation And Biomedical Research On Light And Image

Address

Azinhaga De Santa Comba

City

Coimbra

Postcode

3000-548

Country

Portugal

Scientific contact point

Organisation

Association For Innovation And Biomedical Research On Light And Image

Contact name

Coimbra Coordinating Centre for Clinical Research

Public contact point

Organisation

Association For Innovation And Biomedical Research On Light And Image

Contact name

Coimbra Coordinating Centre for Clinical Research

Third parties 2

Locations

3 EU/EEA countries · 25 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 24 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications