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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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515640-22-00
Acronym
ECR-AMD-2024-15
Enrollment
90
Registered
2025-06-23
Start date
2025-08-06
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

polypoidal choroidal vasculopathy

Brief summary

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.

Detailed description

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., 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., 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, 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 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, 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., 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., Incidence and severity of ocular adverse events (AE)., Incidence and severity of non-ocular AEs.

Interventions

Sponsors

Association For Innovation And Biomedical Research On Light And Image
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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., 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., 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, 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 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, no subretinal fluid and no sub-RPE fluid at Weeks 20, 40, 44, or

Countries

Italy, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026