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

Roche

Status

Enrolling

Conditions

Diabetic Macular Edema

Neovascular Age-related Macular Degeneration

Treatments

Drug: Faricimab

Study type

Observational

Funder types

Industry

Identifiers

NCT06680817

MR45586

Details and patient eligibility

About

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.

Enrollment

850 estimated patients

Sex

All

Ages

18+ years old

Volunteers

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)