Neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME H35.3 H35.30 H36.0
Conditions
Interventions
Group 1: Patients aged 40 years and older with neovascular age-related macular degeneration (nAMD) (approximately 233 patients) or diabetic macular edema (DME) (approximately 50 patients) who received
Sponsors
Roche Pharma AG
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: • Diagnosis of nAMD or DME • Age: =40 years • Three to seven intravitreal injections of bevacizumab before switch to faricimab therapy • At least one intravitreal injection of faricimab after switch • VA in the study eye between 30 and 80 letters of ETDRS (0.08 and 0.8 Snellen decimal) at first faricimab treatment • For retrospective data: Availability of OCT and VA before start of bevacizumab treatment (pre-baseline), before start of faricimab treatment (baseline date) and after the third faricimab injection • Reason for switch: Insufficient anatomic response (i.e., persistent or recurrent or increase in retinal fluid) to bevacizumab therapy • Patient has signed informed consent
Exclusion criteria
Exclusion criteria: • Prior treatment with other anti-VEGF or steroid agents other than bevacizumab before switch to faricimab • Previously treated with photodynamic therapy and retinal laser therapy (study eye) • More than 12 months of bevacizumab therapy • More than four months on faricimab therapy • Other retinal disease/intraocular condition (e.g., secondary choroidal neovascularization [CNV], uveitis, trauma, inflammatory conditions, myopia >-6 diopters, angioid streaks, vision-reducing cataract) that, in the opinion of the treating physician, could affect the VA (study eye) • Current participation in any other ophthalmological interventional and/or non-interventional study • Off-label use of faricimab • Pregnant and/or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the mean change in central subfield thickness (CST, in µm) from baseline to T1 (visit after the third faricimab injection), measured by optical coherence tomography (OCT) in a real-world population of nAMD patients previously treated with bevacizumab | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Secondary Objective: To evaluate the durability of faricimab over time in a real-world nAMD or DME population of previously bevacizumab treated patients. Endpoints: Mean actual and planned faricimab injection interval at month 12 (closest visit). Mean bevacizumab injection interval at switch. Mean and median faricimab injection number over 12 months. Proportion of eyes with an actual and planned faricimab interval length of =Q4W, >Q4W and =Q8W, >Q8W and =Q12W, >Q12W and =Q16W, or longer intervals (>Q16W) at month 12 (closest visit) Variables: Injection interval length per study eye (number of days) and next planned injection. Interval length (number of days) between the last two bevacizumab injections per study eye. Number of faricimab injections per study eye. Status (yes/no) of interval length =Q4W per study eye. Status (yes/no) of interval length >Q4W and =Q8W per study eye. Status (yes/no) of interval length >Q8W and =Q12W per study eye. Status (yes/no) of interval length >Q12W and =Q16W per study eye. Status (yes/no) of interval length >Q16W per study eye. 2. Secondary Objective: To evaluate the effectiveness of faricimab on functional and additional anatomical parameters over time in a real-world nAMD population or DME population of previously bevacizumab treated patients. Endpoints: Mean change in CST from baseline to month 12 (closest visit). Mean change in CST from T1 (visit after the third faricimab injection) to month 12 (closest visit). Mean change in CST from baseline to months 1 and 2 for patients with a loading dose regimen according to faricimab SmPC. Proportion of eyes with presence/absence of intraretinal fluid (IRF) at baseline, T1 (visit after the third faricimab injection) and 12 months after baseline (closest visit). Proportion of eyes with presence/absence of subretinal fluid (SRF) at baseline, T1 (visit after the third faricimab injection) and 12 months after baseline (closest visit). Proportion of eyes with presen | — |
Countries
Germany
Contacts
Public ContactSvenja Deuchler
Augenzentrum Frankfurt
Outcome results
None listed