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 个研究点目标入组 620 人开始时间: 2023年9月7日最近更新: 2024年7月29日

适应症

试验速览

暂无简介。

•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
•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 24 months since the first aVEGF injection (study eye)
•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

•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

发起方

Roche Pharma (Roche Germany)