Observing the use of faricimab for eye conditions in China
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
This study looks at how well and safely the eye treatment faricimab works for people in China with diabetic macular edema, retinal vein occlusion, and age-related macular degeneration.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hoffmann-La Roche Industry-sponsored |
| Drugs / interventions | faricimab |
| Locations | 6 sites (Qingdao and 5 other locations) |
| Trial ID | NCT06439576 on ClinicalTrials.gov |
What this trial studies
The Farseeing Study aims to gather real-world evidence on the long-term effectiveness and safety of faricimab in treating diabetic macular edema, retinal vein occlusion, and neovascular age-related macular degeneration in China. This observational study will collect data from both prospective and retrospective cohorts of patients receiving faricimab in routine clinical practice. By analyzing treatment patterns and outcomes, the study seeks to provide valuable insights into the use of faricimab in these conditions.
Who should consider this trial
Good fit: Ideal candidates include Chinese patients aged 18 and older diagnosed with diabetic macular edema, retinal vein occlusion, or neovascular age-related macular degeneration who are receiving faricimab treatment.
Not a fit: Patients not receiving faricimab or those with active ocular inflammation or infection may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of faricimab's effectiveness and safety, potentially leading to improved treatment strategies for patients with these eye conditions.
How similar studies have performed: Other studies have shown success with similar observational approaches in gathering real-world evidence for treatment effectiveness, making this study a valuable addition to existing knowledge.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Have signed the informed consent 2. Female and male Chinese patients, who had been diagnosed with nAMD, DME, or RVO by CFP, OCT, FFA, ICGA, or OCTA 3. ≥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) 4. Patients for whom the decision to receive treatment with faricimab is made prior to and independent from study participation 5. Patients have received at least one faricimab treatment (the first dose) in the study eye Exclusion Criteria: 1. 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 2. Active ocular inflammation or suspected / active ocular infection in either eye 3. Received any other anti-VEGF treatment after faricimab 4. Received any steroid treatment within 6 months (180 days) before the first faricimab treatment in the study eye 5. Any participation in any other clinical trials currently 6. Patients could not provide the clinical data (visual acuity and OCT images) within 2 weeks (14 days) before receiving the initial faricimab injection
Where this trial is running
Qingdao and 5 other locations
- Qingdao Eye Hospital of Shandong First Medical University — Qingdao, China (Recruiting)
- Shanghai First People's Hospital — Shanghai, China (Recruiting)
- Affiliated Hospital of Shandong Second Medical University — Weifang, China (Recruiting)
- Tongji Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan City, China (Recruiting)
- Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology — Wuhan, China (Recruiting)
- Hebei Eye Hospital — Xingtai, China (Recruiting)
Study contacts
- Study coordinator: Reference Study ID Number: ML45401 https://forpatients.roche.com/
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728 (U.S. Only)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.