A non-interventional, multicenter study to investigate effectiveness, safety and quality of life in nAMD switch patients treated with faricimab under real world conditions in Germany

Roche Pharma (Roche Germany)0 sites620 target enrollmentSeptember 7, 2023

Overview

No summary available.

Registry

who.int

Start Date

September 7, 2023

End Date

June 30, 2027

Last Updated

last year

Study Type

Observational

Sex

All

Sponsor

Roche Pharma (Roche Germany)

•Current inclusion criteria as of 17/07/2024:
•1\. Signed informed consent
•2\. Diagnosis of nAMD
•3\. Is at least 50 years old
•4\. Previously treated with an (anti) vascular endothelial growth factor (aVEGF)\-drug (at least 3 doses) but no longer than 36 months since the first aVEGF injection (study eye) with clinical features of diabetic retinopathy (e.g.: microaneuryms, hemorrhages, etc.)
•5\. The last injection of the previous aVEGF has to be longer than 4 weeks before the first faricimab injection
•6\. Active nAMD, defined as persistent IRF and/or SRF on OCT despite treatment with aVEGF therapy or participants who could benefit from treatment intervals beyond their current standard treatment
•7\. BCVA in the study eye between 30 and 80 letters of ETDRS at first faricimab treatment
•Previous inclusion criteria:
•1\. Signed informed consent

•1\. Off\-label use of faricimab
•2\. Previously treated with photodynamic therapy and retinal laser therapy (study eye)
•3\. Other retinal disease/intraocular condition (e.g., diabetic retinopathy, diabetic macular oedema, myopia \>\-6 diopter, angioid streaks, vision\-reducing cataract) that, in the opinion of the investigator, could have an influence on the visual acuity (study eye)
•4\. Medical history of diabetes type 1 or 2
•5\. Participation in any other ophthalmological interventional and/or non\-interventional study
•6\. Previously treated with faricimab (study eye); however, the first faricimab treatment may have occurred up to 12 weeks prior to enrollment
•7\. Pregnant and/or breastfeeding