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

Launched by HOFFMANN-LA ROCHE · May 28, 2024

Keywords

ClinConnect Summary

The Farseeing Study is a clinical trial that aims to understand how well the drug faricimab works in treating conditions like diabetic macular edema (DME), neovascular age-related macular degeneration (nAMD), and retinal vein occlusion (RVO) in real-world settings in China. Researchers want to learn about the long-term effectiveness, safety, and the ways doctors are using this treatment in everyday practice. This study will gather information by observing patients who are already receiving faricimab treatment and collecting data on their progress.

To participate in this study, individuals must be at least 50 years old for nAMD, or at least 18 years old for DME and RVO, and they need to have been diagnosed with one of these conditions. They must have agreed to participate in the study and received at least one treatment with faricimab. It’s important to note that participants should not have any active eye infections, inflammation, or been part of another clinical trial recently. Those who join can expect to share their medical information, like vision tests and eye scans, which will help the researchers gather important data about how well faricimab works for them over time.

Gender

ALL

Eligibility 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

Trial Officials