A Real-World Study to Gain Clinical Insights Into Faricimab (FaReal Study)

Launched by HOFFMANN-LA ROCHE · Nov 6, 2024

Keywords

ClinConnect Summary

The FaReal Study is a clinical trial designed to understand how effective and safe a medication called faricimab is for patients with certain eye conditions, specifically neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). Over a period of two years, researchers will gather information on how well this treatment works in everyday clinical settings and also look into the costs associated with previous treatments compared to faricimab. This study is currently recruiting participants, and it's open to adults aged 65 and older who are either starting treatment with faricimab or have begun treatment within the last three months.

To qualify for the trial, participants need to have one of the specified eye conditions and have received at least one dose of faricimab in the eye being treated. However, there are some criteria that could exclude someone from participating, such as ongoing participation in other clinical trials or specific eye infections. Those who join the study can expect regular check-ups and monitoring over the two years, helping us learn more about this treatment in a real-world setting.

Gender

ALL

Eligibility criteria

• 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)