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NCT Number: NCT06439576

Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)

The Farseeing Study will explore long-term effectiveness, safety, and treatment patterns among patients being treated with faricimab in real-world, routine clinical practice in China. It is a primary data collection, non-interventional, prospective and retrospective, multi-center study designed to collect real-world, long-term data to gain clinical evidence on faricimab, by observing cohorts of patients with neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and retinal vein occlusion (RVO) who are receiving treatment with faricimab.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Diabetic Macular Edema Cardiovascular Diseases Embolism and Thrombosis Eye Diseases Neovascular Age-related Macular Degeneration Retinal Diseases Retinal Vein Occlusion Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Joint Shantou International Eye Center, Shantou, Guangdong, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Have signed the informed consent
  • Female and male Chinese patients, who had been diagnosed with nAMD, DME, or RVO by CFP, OCT, FFA, ICGA, or OCTA
  • ≥50 years old for patients with nAMD, ≥18 years old both for patients with DME and RVO, at the time of signing informed consent (or the first administration of faricimab, whichever occurs first)
  • Patients for whom the decision to receive treatment with faricimab is made prior to and independent from study participation
  • Patients have received at least one faricimab treatment (the first dose) in the study eye

Exclusion criteria

  • Patients not receiving treatment for nAMD/DME/RVO with faricimab according to the standard of care and in line with the current summary of product characteristics (SPC) / labeling in China
  • Active ocular inflammation or suspected / active ocular infection in either eye
  • Received any other anti-VEGF treatment after faricimab
  • Received any steroid treatment within 6 months (180 days) before the first faricimab treatment in the study eye
  • Any participation in any other clinical trials currently
  • Patients could not provide the clinical data (visual acuity and OCT images) within 2 weeks (14 days) before receiving the initial faricimab injection

Treatment and study plan

Faricimab

Drug

The dosing and treatment duration of the studied medicinal product is at the discretion of the physician in accordance with clinical practice and labeling in China.

Other names: VABYSMO®

Primary outcomes

  1. Change in Visual Acuity from Baseline at Month 12

    Time frame: Baseline and Month 12

    Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score.

Secondary outcomes

  1. Visual Acuity Over Time

    Time frame: Baseline, Months 3, 6, 9, 12, 18, and 24

  2. Change in Visual Acuity from Baseline Over Time

    Time frame: Baseline, Months 3, 6, 9, 18, and 24

  3. Central Subfield Thickness Over Time

    Time frame: Baseline, Months 3, 6, 9, 12, 18, and 24

  4. Change in Central Subfield Thickness from Baseline Over Time

    Time frame: Baseline, Months 3, 6, 9, 12, 18, and 24

  5. Percentage of Eyes on Each Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other)

    Time frame: From Baseline to Month 24

  6. Number of Treatments per Year

    Time frame: Months 12 and 24

  7. Percentage of Eyes with Treatment Switch by Reason for Switch Over Time

    Time frame: Months 3, 6, 9, 12, 18, and 24

  8. Percentage of Eyes with Treatment Regimen Switch (Fixed, Treat-and-Extend, As Needed, or Other) by Reason for Switch Over Time

    Time frame: Months 3, 6, 9, 12, 18, and 24

  9. Total Number of Visits per Year

    Time frame: Months 12 and 24

  10. Number of Visits With or Without Treatment per Year

    Time frame: Months 12 and 24

  11. Time Interval Between Treatments per Year

    Time frame: Months 12 and 24

  12. Percentage of Eyes Treated with Ocular Concomitant Medications or Therapy by Type and Frequency During the Study

    Time frame: From Baseline until end of study (up to 3.5 years)

  13. Number of Participants Lost to Follow-Up More Than 6 Months at Months 12, 18, and 24

    Time frame: Months 12, 18, and 24

  14. Percentage of Eyes According to the Last Treatment Interval at Months 3, 6, 12, 18, and 24

    Time frame: Months 3, 6, 12, 18, and 24

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Collaborators

  • Shanghai Roche Pharmaceutical Co., Ltd

Registry information

Official study title

China Faricimab Real World Evidence: Evaluation of Faricimab Effectiveness, Safety and Treatment Pattern, in Diabetic Macular Edema, Retinal Vein Occlusion and Neovascular Age-Related Macular Degeneration: The Farseeing Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jun 3, 2024
Registry last updated
May 12, 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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