Neovascular Age-related Macular Degeneration
Conditions
Brief summary
The goal of this retrospective single-center chat review is to establish the efficacy and safety of a single dose of intravitreal faricimab (Vabysmo®) injection in patients with neovascular age-related macular degeneration (AMD), who were previously treated with aflibercept (Eylea®) and had persisting intraretinal or subretinal fluid despite frequent treatments.
Interventions
DRUGFaricimab
The Injections were performed according to local standard protocol, that included the use of 2-3 drops of topical tetracaine anesthesia, use of eye speculum, topical 5% povidone-iodine disinfection, a 30G-needle, injection site 3.5 mm posterior from the limbus marked by calipers in supertemporal or inferotemporal quadrants, a sterile cotton tip tamponade at the site of injection after removal of the needle, and no post-procedure antibiotics.
Sponsors
Rigshospitalet, Denmark
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Presence of neovascular age-related macular degeneration (AMD) in the study eye * \>50 years of age * Previous intravitreal anti-VEGF treatment with aflibercept (Eylea®) or with aflibercept and ranibizumab (Lucentis®) in the study eye * Minimum of 6 monthly aflibercept injections * Persisting intraretinal or subretinal fluid or both, despite at least 3 consecutive monthly aflibercept injections in the study eye before switching to faricimab
Exclusion criteria
* Neovascular conditions other than AMD (e.g., choroidal neovascularisation due to other causes) or co-existence of other retinal disease in the study eye * Significant optical media opacities that would result in poor imaging quality on OCT scans in the study eye * Intraocular surgery in the study eye 3 months before or within 1 month after the treatment switch
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients responding to the treatment switch | 4 weeks | Defined as reduction or disappearance of the intra- or subretinal fluid at 4 weeks following a single injection of faricimab |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Durability of a single injection in cases of favorable treatment response without residual fluid | Up to 16 weeks | Time of reappearance of the fluid |
| Differences in patient characteristics between individuals responding and not responding to faricimab | 4 weeks | — |
| Changes in central retinal thickness after the treatment switch | 4 weeks | Measured on optical coherence tomography (OCT) scans |
| Changes in pigment epithelium detachment (PED) height after the treatment switch | 4 weeks | Measured on optical coherence tomography (OCT) scans |
| Changes in visual acuity after the treatment switch | 4 weeks | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Frequency of ocular and systemic adverse events | 4 weeks | As safety endpoint |
Countries
Denmark
Outcome results
None listed