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A Real-World Study to Gain Clinical Insights Into Faricimab (FaReal Study)
- Eye Disorder
- Neovascular Age-related Macular Degeneration
- Wet Age-Related Macular Degeneration
- Diabetic Macular Edema
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:
Not yet recruiting
This study runs in
N/A
Trial Identifier:
NCT06680817 MR45586
Study Summary
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.
Hoffmann-La Roche
Sponsor
N/A
Phase
NCT06680817, MR45586
Trial Identifier
Faricimab
Treatments
Neovascular Age-related Macular Degeneration, Diabetic Macular Edema
Condition
Official Title
Real-World, Long-Term Data Collection to Gain Clinical Insights Into Faricimab (FaReal Study)
Eligibility Criteria
All
Gender
≥18 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- Patients, as defined by local regulations and local faricimab product label, who are initiating treatment with faricimab at time of enrollment or have initiated treatment with faricimab within 3 months prior to patient enrollment, in diabetic macular edema (DME) or neovascular age-related macular degeneration (nAMD) in at least one eye according to the investigator's discretion in routine clinical practice for anti-VEGF treatment naïve and pre-treated patients.
- Patients have received at least one faricimab treatment (the first dose) in the study eye.
Exclusion Criteria
- Concomitant participation of the patient in any investigational ophthalmology clinical trial that includes receipt of any ophthalmological investigational drug or procedure within the last 28 days prior to enrollment
- Current participation in any interventional clinical study
- Active ocular inflammation and/or suspected/active ocular infection in either eye
- Patients in whom the study eye has been treated with faricimab for more than 3 months prior to enrollment
- 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)
- Patients with non-ocular sight threatening disease which have an effect on the primary endpoint (e.g., apoplexia)
- Hypersensitivity to the active substance or any of the excipients of Vabysmo (as per label)
For the latest version of this information please go to www.forpatients.roche.com