Single Injection of Faricimab for nAMD With Persisting Fluid Despite Frequent Aflibercept Treatments

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Neovascular Age-related Macular Degeneration

Intervention / Treatment
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* Drug: Faricimab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Patients who received intravitreal faricimab injections between May and September, in 2023. and conform the inclusion/exclusion criteria. | Drug: Faricimab<br>* 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.<br>* Other names: Vabysmo (6 mg, 0.05 ml);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients responding to the treatment switch | Defined as reduction or disappearance of the intra- or subretinal fluid at 4 weeks following a single injection of faricimab | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Durability of a single injection in cases of favorable treatment response without residual fluid | Time of reappearance of the fluid | Up to 16 weeks | 
| Differences in patient characteristics between individuals responding and not responding to faricimab |  | 4 weeks | 
| Changes in visual acuity after the treatment switch |  | 4 weeks | 
| Changes in central retinal thickness after the treatment switch | Measured on optical coherence tomography (OCT) scans | 4 weeks | 
| Changes in pigment epithelium detachment (PED) height after the treatment switch | Measured on optical coherence tomography (OCT) scans | 4 weeks |