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

  • Eye Disorder
  • Neovascular Age-related Macular Degeneration
  • Wet Age-Related Macular Degeneration
  • Diabetic Macular Edema
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:

Not yet recruiting

This study runs in
N/A
Study Identifier:

NCT06680817 MR45586

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Study 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 also aims to describe and evaluate health economic aspects of previous anti-VEGF treatments and current treatment with faricimab.

      Hoffmann-La Roche Sponsor
      N/A Phase
      NCT06680817, MR45586 Study Identifier
      Faricimab Treatments
      Neovascular Age-related Macular Degeneration, Diabetic Macular Edema Condition
      Official Title

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

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      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.
      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)

      For the latest version of this information please go to www.forpatients.roche.com

       

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