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

Roche

Status: Enrolling

Conditions: Diabetic Macular Edema; Neovascular Age-related Macular Degeneration

Treatments: Drug: Faricimab

Study type: Observational

Funder types: Industry

Identifiers

NCT06680817

MR45586

Details and patient eligibility

About

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.

Enrollment: 850 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

850 participants in 2 patient groups

Cohort 1: Faricimab for nAMD

Description:

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

Treatment:

Drug: Faricimab

Cohort 2: Faricimab for DME

Description:

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

Treatment:

Drug: Faricimab