Real-World, Long-Term Data Collection to Gain Clinical Insights Into Faricimab (FaReal Study)

Hoffmann-La Roche109 sites in 13 countries850 target enrollmentFebruary 5, 2025

ConditionsNeovascular Age-related Macular Degeneration Diabetic Macular Edema

InterventionsFaricimab

DrugsFaricimab

Overview

Phase: N/A
Intervention: Faricimab
Conditions: Neovascular Age-related Macular Degeneration
Sponsor: Hoffmann-La Roche
Enrollment: 850
Locations: 109
Primary Endpoint: Change in Visual Acuity from Index Date to 12 Months
Status: Recruiting
Last Updated: 19 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The FaReal study aims to evaluate the effectiveness, safety, clinical insights and treatment patterns in patients treated with faricimab, in neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME) in at least one eye, in real-world routine clinical practice over a 2-year patient follow-up period. Additionally, the FaReal study also aims to describe and evaluate health economic aspects of previous anti-VEGF treatments and current treatment with faricimab.

Registry

clinicaltrials.gov

Start Date

February 5, 2025

End Date

June 30, 2028

Last Updated

19 days ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients receiving faricimab according to the local faricimab product label and who have initiated treatment with faricimab at time of the ICF signature date or no more than 3 months prior to the ICF signature date, in diabetic macular edema (DME) or neovascular age-related macular degeneration (nAMD) in at least one eye
•Patients have received at least one faricimab treatment (the first dose) in the study eye
•Patients should have available data for visual acuity (VA) and Central Subfield Thickness (CST) for the Baseline level (i.e. examinations to be performed at the index date or within 4 months prior to it)

Exclusion Criteria

•Patient participation in any investigational ophthalmology clinical trial that includes receipt of any ophthalmological investigational drug or procedure within the last 28 days prior to the ICF signature date
•Concomitant participation in any interventional clinical study
•Active ocular inflammation and/or suspected/active ocular infection in either eye
•Patients treated with faricimab who have and are currently participating in patient support programs (PSP) that are Market Research and Patient Support Programs (MAP) including Post Trial Access Programs (PTAP) and Compassionate Use Programs (CUP)
•Patients with non-ocular sight threatening disease which have an effect on the primary endpoint (e.g., apoplexia)
•Hypersensitivity to the active substance or any of the excipients of Vabysmo (as per label)

Arms & Interventions

Cohort 1: Faricimab for nAMD

This cohort will be divided into two sub-cohorts based on eye treatment history: anti-VEGF treatment naive and anti-VEGF pre-treated.

Intervention: Faricimab

Cohort 2: Faricimab for DME

This cohort will be divided into two sub-cohorts based on eye treatment history: anti-VEGF treatment naive and anti-VEGF pre-treated.

Intervention: Faricimab

Outcomes

Primary Outcomes

Change in Visual Acuity from Index Date to 12 Months

Time Frame: Index Date and 12 months

The index date is defined as the date of the first faricimab treatment injection in the eye.

Secondary Outcomes

Cumulative Time Spent in Each Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other)(From Index Date to 24 months)
Change in Visual Acuity from Index Date Over Time, According to Number of Intravitreal Treatments(Index Date and 3, 6, 12, and 24 months)
Change in Visual Acuity from Index Date Over Time, According to Treatment Intervals(Index Date and 3, 6, 12, and 24 months)
Change in Visual Acuity from Index Date Over Time, According to Length of Diagnosis of Disease at Index Date(Index Date and 3, 6, 12, and 24 months)
Number of Participants with at Least One Non-Ocular Adverse Event(Approximately 2 years)
Change in Visual Acuity from Index Date to 3, 6, and 24 Months(Index Date and 3, 6, and 24 months)
Change in Central Subfield Thickness (CST) from Index Date to 3, 6, 12, and 24 Months(Index Date and 3, 6, 12, and 24 months)
Percentage of Eyes on Each Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other) Over Time(Index Date and 3, 6, 12, and 24 months)
Number of Faricimab Intravitreal Injections per Eye per Year(12 and 24 months)
Number of Faricimab Intravitreal Injections in the Loading Phase for Participants who are anti-VEGF Treatment Naive or anti-VEGF pre-Treated(Approximately 4 months)
Total Number of Visits and Number of Visits With or Without Treatment Over Time(3, 6, 12, and 24 months)
Cumulative Time Spent in Each Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other)(From Index Date to 24 months)
Percentage of Eyes With Treatment Switch from Faricimab by Reason for Switch in Participants who are anti-VEGF Treatment Naive or anti-VEGF pre-Treated(3, 6, 12, and 24 months)
Percentage of Eyes Obtaining Treatment Intervals of Once Every 8, 12, or 16 Weeks or Other Intervals in Participants who are anti-VEGF Treatment Naive or anti-VEGF pre-Treated(12 and 24 months)
Change in Visual Acuity from Index Date Over Time, According to Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other)(Index Date and 3, 6, 12, and 24 months)
Change in Visual Acuity from Index Date Over Time, According to Number of Intravitreal Treatments(Index Date and 3, 6, 12, and 24 months)
Change in Visual Acuity from Index Date Over Time, According to Total Number of Visits(Index Date and 3, 6, 12, and 24 months)
Change in Visual Acuity from Index Date Over Time, According to Treatment Intervals(Index Date and 3, 6, 12, and 24 months)
Change in Visual Acuity from Index Date Over Time, According to Type of anti-VEGF Pre-Treatment and Number of Previous Injections for Preceding Regimen at Index Date(Index Date and 3, 6, 12, and 24 months)
Change in Visual Acuity from Index Date Over Time, According to Length of Diagnosis of Disease at Index Date(Index Date and 3, 6, 12, and 24 months)
Number of Participants with at Least One Ocular Adverse Event(Approximately 2 years)
Number of Participants with at Least One Non-Ocular Adverse Event(Approximately 2 years)