Actively Recruiting
Real-World, Long-Term Data Collection to Gain Clinical Insights Into Faricimab for Neovascular Age-related Macular Degeneration and Diabetic Macular Edema
Led by Hoffmann-La Roche · Updated on 2026-05-11
850
Participants Needed
59
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of faricimab in patients with neovascular age-related macular degeneration nAMD or diabetic macular edema DME affecting at least one eye. This observational study aims to evaluate the effectiveness, safety, treatment patterns, and health economics of faricimab in real-world clinical practice over a two-year follow-up period. The study includes patients both new to anti-VEGF treatment and those who have been previously treated with anti-VEGF therapies. Participants will receive faricimab as guided by local clinical practice and labeling. The study divides participants into two sub-cohorts based on their prior eye treatment history those naive to anti-VEGF treatment and those previously treated. The study is designed to observe treatment regimens, dosing, and clinical outcomes in routine care settings without experimental interventions. During the study, participants will be monitored for changes in visual acuity and central subfield thickness at multiple time points up to 24 months. Researchers will collect data on injection frequency, treatment intervals, and any switch in treatment. Safety will be assessed by tracking ocular and non-ocular adverse events. The study emphasizes the collection of real-world clinical and economic data, following each patient for up to two years.
CONDITIONS
Brief Title
A Real-World Study to Gain Clinical Insights Into Faricimab (FaReal Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients receiving faricimab according to local product labeling who started treatment at or within 3 months before consent
- Patients with diabetic macular edema or neovascular age-related macular degeneration in at least one eye
- Patients who have received at least one faricimab injection in the affected eye
- Patients with available visual acuity and central subfield thickness data at baseline or within 4 months prior
You will not qualify if you...
- Participation in any investigational ophthalmology trial with investigational drugs or procedures within 28 days before consent
- Concurrent participation in any interventional clinical study
- Active eye inflammation or suspected/active eye infection in either eye
- Participation in patient support programs such as market research, post-trial access, or compassionate use programs
- Presence of non-ocular sight-threatening diseases affecting the primary study endpoint
- Known hypersensitivity to faricimab or any of its components as per product label
Research Team
R
Reference Study ID Number: MR45586 https://forpatients.roche.com/
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