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

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

Recruiting
18 years and older
All
Phase N/A

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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.

Eligibility

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)

Study details
    Neovascular Age-related Macular Degeneration
    Diabetic Macular Edema

NCT06680817

Hoffmann-La Roche

1 November 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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