A Real-World Study to Gain Clinical Insights Into Faricimab (FaReal Study)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHoffmann-La Roche
About this trial
The FaReal study aims to evaluate the effectiveness, safety, clinical insights and treatment patterns in patients treated with faricimab, in neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME) in at least one eye, in real-world routine clinical practice over a 2-year patient follow-up period. Additionally, the FaReal study also aims to describe and evaluate health economic aspects of previous anti-VEGF treatments and current treatment with faricimab.
Eligibility criteria
Qualifiers
Patients receiving faricimab according to the local faricimab product label and who have initiated treatment with faricimab at time of the ICF signature date or no more than 3 months prior to the ICF signature date, in diabetic macular edema (DME) or neovascular age-related macular degeneration (nAMD) in at least one eye
Patients have received at least one faricimab treatment (the first dose) in the study eye
Patients should have available data for visual acuity (VA) and Central Subfield Thickness (CST) for the Baseline level (i.e. examinations to be performed at the index date or within 4 months prior to it)
Disqualifiers
Patient participation in any investigational ophthalmology clinical trial that includes receipt of any ophthalmological investigational drug or procedure within the last 28 days prior to the ICF signature date
Concomitant participation in any interventional clinical study
Active ocular inflammation and/or suspected/active ocular infection in either eye
Patients treated with faricimab who have and are currently participating in patient support programs (PSP) that are Market Research and Patient Support Programs (MAP) including Post Trial Access Programs (PTAP) and Compassionate Use Programs (CUP)
Trial design
Treatments tested in this trial
- Faricimab
Treatment groups
850 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov