Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, an… (NCT06439576) | Clinical Trial Compass
RecruitingNot Applicable
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
China1,000 participantsStarted 2024-05-09
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
Change in Visual Acuity from Baseline at Month 12
Timeframe: Baseline and Month 12
Trial details
NCT IDNCT06439576
SponsorHoffmann-La Roche
Sponsor typeINDUSTRY
Study typeOBSERVATIONAL
Primary completion2026-11-15
Contact for this trial
Reference Study ID Number: ML45401 https://forpatients.roche.com/
. 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