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

Hoffmann-La Roche850 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

850

Conditions

Neovascular Age-related Macular Degeneration Diabetic Macular Edema

Interventions

FaricimabDRUG

Faricimab will be administered as per local clinical practice and local labeling.

Eligibility

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Change in Visual Acuity from Index Date to 12 Months

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

Time frame: Index Date and 12 months

Secondary Outcomes

Change in Visual Acuity from Index Date to 3, 6, and 24 Months

Time frame: Index Date and 3, 6, and 24 months

Change in Central Subfield Thickness (CST) from Index Date to 3, 6, 12, and 24 Months

Time frame: 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

Time frame: Index Date and 3, 6, 12, and 24 months

Number of Faricimab Intravitreal Injections per Eye per Year

Time frame: 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

Time frame: Approximately 4 months

Total Number of Visits and Number of Visits With or Without Treatment Over Time

Time frame: 3, 6, 12, and 24 months

Cumulative Time Spent in Each Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other)

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: Index Date and 3, 6, 12, and 24 months

Change in Visual Acuity from Index Date Over Time, According to Number of Intravitreal Treatments

Time frame: Index Date and 3, 6, 12, and 24 months

Change in Visual Acuity from Index Date Over Time, According to Total Number of Visits

Time frame: Index Date and 3, 6, 12, and 24 months

Change in Visual Acuity from Index Date Over Time, According to Treatment Intervals

Time frame: 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

Time frame: 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

Time frame: Index Date and 3, 6, 12, and 24 months

Number of Participants with at Least One Ocular Adverse Event

Time frame: Approximately 2 years

Number of Participants with at Least One Non-Ocular Adverse Event

Time frame: Approximately 2 years

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

Overview

Conditions

Interventions

Eligibility

Locations (54)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts