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Clinical trial

Anatomical and Visual Outcomes Following a Single Injection of Intravitreal Faricimab in Patients With Neovascular Age-related Macular Degeneration and Persisting Fluid Despite Frequent Aflibercept Treatments

ID
Name
VAB1SHOT
Description
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.
Trial arms
Trial start
2023-11-01
Estimated PCD
2023-11-15
Trial end
2023-12-01
Status
Completed
Treatment
Faricimab
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.
Arms:
Patients
Other names:
Vabysmo (6 mg, 0.05 ml)
Size
46
Primary endpoint
Proportion of patients responding to the treatment switch
4 weeks
Eligibility criteria
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 46, 'type': 'ACTUAL'}}
Updated at
2023-12-11

1 organization

1 product

1 indication

Organization
Rigshospitalet
Product
Faricimab
Indication
Age-Related Macular Degeneration