Neovascular age related macular degeneration (nAMD) Eye Diseases
Conditions
Interventions
Participants will be observed for effectiveness, safety, and quality of life once every 4 weeks during the loading dose phase (if applicable) and thereafter according to routine clinical practice for
Sponsors
Roche Pharma (Roche Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline in visual acuity measured per local practice at Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of participants with an extended treatment interval without losing >4 letters in best-corrected visual acuity (BCVA) compared to baseline measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 and Week 104 2. Percentage of participants with an extended treatment interval compared to baseline measured by ETDRS Letter Score at Week 52 and Week 104 3. Percentage of participants in different treatment intervals compared to baseline measured using data collected on the electronic case report form (eCRF) after 52 Weeks 4. Percentage of participants in different treatment intervals compared to baseline measured using data collected on the eCRF after 104 Weeks 5. Mean change from baseline in visual acuity assessed using ETDRS Letter Score at Week 104 6. Mean change from baseline in central subfield thickness (CST) measured by the reading center using OCT from baseline up to Week 104 7. Mean change from baseline in central point thickness (CPT), measured by the investigator using OCT from baseline up to Week 104 8. Percentage of participants with the absence of intraretinal fluid (IRF) within the ETDRS Grid measured by the investigator using OCT from baseline up to Week 104 9. Percentage of participants with the absence of subretinal fluid (SRF) within the ETDRS Grid measured by the investigator using OCT from baseline up to Week 104 10. Percentage of participants with absence of sub-retinal pigment epithelium fluid (Sub-RPE fluid) within the ETDRS grid measured by the investigator using OCT from baseline up to Week 104 11. Percentage of participants with absence of IRF and SRF within the ETDRS grid measured by the investigator using OCT from baseline up to Week 104 12. Percentage of participants with absence of IRF, SRF and Sub-RPE fluid within the ETDRS grid measured by the investigator using OCT from baseline up to Week 104 13. Percentage of participants with pigment epithelial detachment (PED) within the ETDRS grid measured b | — |
Countries
Germany
Contacts
Public ContactClinical Trials
Outcome results
None listed