A Real-World Study to Gain Clinical Insights Into Roche Ophthalmology Products

  • Neovascular Age-related Macular Degeneration
  • Diabetic Macular Edema
Trial Status:

Not yet recruiting

This trial runs in
Countries
Trial Identifier:

NCT05476926 MR41927

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

      Results Disclaimer

      Trial Summary

      The VOYAGER study is a primary data collection, non-interventional, prospective, multinational, multicenter study. It is designed to collect real-world, long-term data to explore long-term effectiveness, safety, clinical insights, treatment patterns, and factors driving the treatment decisions among patients being treated with specified Roche ophthalmology products (Faricimab and Port Delivery System with Ranibizumab) in approved retinal indications (neovascular age-related macular degeneration [nAMD] and diabetic macular edema [DME]) in routine clinical practice. This study will not provide or make recommendations on use of any products including Roche products; treatment decisions will be determined by the treating physician and must be made independently to the decision to participate in this study. Participation in this study will not change or influence a patient's standard of care in any way. The study start in a country is contingent on the approval of at least one product.

      Hoffmann-La Roche Sponsor
      NCT05476926 , MR41927 Trial Identifier
      Faricimab, Port Delivery System with Ranibizumab Treatments
      Neovascular Age-related Macular Degeneration, Diabetic Macular Edema Condition
      Official Title

      Real-World, Long-Term Data Collection to Gain Clinical Insights Into Roche Ophthalmology Products (VOYAGER STUDY)

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Have provided informed consent, as required per local regulations
      • Adult patients, as defined by local regulations and local product label, who are being treated with any approved Roche ophthalmology product in retinal indication in scope for this study, according to the investigator's discretion in routine clinical practice (irrespective of whether the patient is starting treatment at the time of enrollment or is already receiving treatment). Patients are also considered eligible if they are rolling over from Roche interventional studies and continuing treatment with any specified approved Roche ophthalmology product in retinal indication in scope for this study
      Exclusion Criteria
      • Concomitant participation in an investigational ophthalmology clinical trial that includes receipt of any investigational drug or procedure within the last 28 days prior to enrollment (this restriction does not apply to patients who are rolling over from Roche interventional studies and continuing treatment with any specified approved Roche ophthalmology product in retinal indication in scope for this study)

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