A study investigating the effectiveness, safety and quality of life in participants with age related visual impairment (macular degeneration) who have switched to faricimab, under real world conditions in Germany
- Conditions
- eovascular age related macular degeneration (nAMD)Eye Diseases
- Registration Number
- ISRCTN27514808
- Lead Sponsor
- Roche Pharma (Roche Germany)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 620
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change from baseline in visual acuity measured per local practice at Week 52
- Secondary Outcome Measures
Name Time Method