A Real-World Study to Gain Clinical Insights Into Faricimab (FaReal Study)

Registration Number
NCT06680817
Lead Sponsor
Hoffmann-La Roche
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 als...

Detailed Description

Not available

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
850
Inclusion Criteria
  • Patients, as defined by local regulations and local faricimab product label, who are initiating treatment with faricimab at time of enrollment or have initiated treatment with faricimab within 3 months prior to patient enrollment, in diabetic macular edema (DME) or neovascular age-related macular degeneration (nAMD) in at least one eye according to the investigator's discretion in routine clinical practice for anti-VEGF treatment naïve and pre-treated patients.
  • Patients have received at least one faricimab treatment (the first dose) in the study eye.
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Exclusion Criteria
  • Concomitant participation of the patient in any investigational ophthalmology clinical trial that includes receipt of any ophthalmological investigational drug or procedure within the last 28 days prior to enrollment
  • Current participation in any interventional clinical study
  • Active ocular inflammation and/or suspected/active ocular infection in either eye
  • Patients in whom the study eye has been treated with faricimab for more than 3 months prior to enrollment
  • 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)
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Cohort 1: Faricimab for nAMDFaricimab-
Cohort 2: Faricimab for DMEFaricimab-
Primary Outcome Measures
NameTimeMethod
Change in Visual Acuity from Index Date to 12 MonthsIndex Date and 12 months

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

Secondary Outcome Measures
NameTimeMethod
Change in Central Subfield Thickness (CST) from Index Date to 3, 6, and 24 MonthsIndex Date and 3, 6, and 24 months
Percentage of Eyes on Each Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other) Over TimeIndex Date and 3, 6, 12, and 24 months
Number of Faricimab Intravitreal Injections per Eye per Year12 and 24 months
Number of Faricimab Intravitreal Injections in the Loading Phase for Participants who are Treatment Naive or anti-VEGF pre-TreatedApproximately 4 months
Total Number of Visits and Number of Visits With or Without Treatment Over Time3, 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 Treatment Naive or anti-VEGF pre-Treated3, 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 Treatment Naive or anti-VEGF pre-Treated12 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 TreatmentsIndex Date and 3, 6, 12, and 24 months
Change in Visual Acuity from Index Date Over Time, According to Total Number of VisitsIndex Date and 3, 6, 12, and 24 months
Change in Visual Acuity from Index Date Over Time, According to Treatment IntervalsIndex Date and 3, 6, 12, and 24 months
Change in Visual Acuity from Index Date Over Time, According to Type of Pre-Treatment and Number of Previous Injections for Preceding Regimen at Index DateIndex 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 DateIndex Date and 3, 6, 12, and 24 months
Number of Participants with at Least One Ocular Adverse EventApproximately 2 years
Number of Participants with at Least One Non-Ocular Adverse EventApproximately 2 years
Change in Visual Acuity from Index Date to 3, 6, and 24 MonthsIndex Date and 3, 6, and 24 months
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