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NCT Number: NCT06680817

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

LKH-Univ.Klinikum Graz, Graz, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Faricimab

Drug

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

Other names: VABYSMO®, RO6867461, RG7716

Primary outcomes

  1. 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

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

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

  2. 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

  3. 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

  4. Number of Faricimab Intravitreal Injections per Eye per Year

    Time frame: 12 and 24 months

  5. 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

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

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

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

    Time frame: From Index Date to 24 months

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

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

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

  14. 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

  15. 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

  16. Number of Participants with at Least One Ocular Adverse Event

    Time frame: Approximately 2 years

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

    Time frame: Approximately 2 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Nov 8, 2024
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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