Ophthalmology and therapy · 2026
Prospective Real-World Outcomes After Switching to Aflibercept 8 mg in Neovascular Age-Related Macular Degeneration with High Treatment Burden.
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Spartalis Christoph, Ullrich Marlies, Winkler Silvia, Leisser Christoph, Ruiss Manuel, Pilwachs Caroline, Findl Oliver
Аннотация
INTRODUCTION: This study aimed to evaluate functional, anatomical, and safety outcomes after switching from aflibercept 2 mg to aflibercept 8 mg in patients with neovascular age-related macular degeneration (nAMD) requiring short re-treatment intervals in a real-world setting.
METHODS: This single-center prospective observational study included patients with nAMD insufficiently responsive to prior anti-vascular endothelial growth factor (anti-VEGF) therapy requiring re-treatment every 4-6 weeks. All eyes had received four consecutive intravitreal injections of aflibercept 2 mg prior to switching to aflibercept 8 mg as part of routine clinical management. Functional outcome was assessed by distance-corrected visual acuity (DCVA). Anatomical outcomes included central retinal thickness (CRT), central subfield thickness (CST), and optical coherence tomography (OCT) features. Injection burden, responder status, discontinuation, and safety outcomes were evaluated. Follow-up occurred at 3, 6, 9, and 12 months.
RESULTS: Fifty patients (50 eyes) were included (mean age 78.4 ± 6.9 years; 60% female). Median baseline DCVA was 0.19 logMAR (IQR 0.12-0.32; 75.5 ETDRS letters), median CST 272 µm, and median CRT 338 µm. DCVA improved significantly at months 3, 6, and 9 (p ≤ 0.046) and remained stable at month 12. CRT and CST decreased early and remained improved. Over 12 months, 24 patients (48%) completed follow-up, while 26 (52%) discontinued early. Intraocular inflammation (IOI) occurred in 10 eyes (20%), corresponding to 3.0% per injection, and was temporally associated with off-label aliquoted preparation; all cases resolved without permanent visual loss. No further IOI events were observed after transition to on-label preparation. During safety evaluation, seven patients discontinued aflibercept 8 mg as a result of precautionary safety measures. Seventeen (34%) required ≤ 8 injections per year.
CONCLUSIONS: In chronically treated patients with nAMD requiring short re-treatment intervals, switching to aflibercept 8 mg was associated with modest anatomical improvement and stable visual function. A reduction in treatment burden was observed in a subset of patients, although overall durability remained heterogeneous and discontinuation rates were high. A cluster of sterile inflammatory events occurred during off-label aliquoted preparation, highlighting the importance of appropriate drug handling. Careful patient selection and strict adherence to on-label preparation procedures are essential to optimize safety. These findings should be interpreted cautiously given the exploratory design, lack of a comparator group, and high discontinuation rate.
TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT07390253.
METHODS: This single-center prospective observational study included patients with nAMD insufficiently responsive to prior anti-vascular endothelial growth factor (anti-VEGF) therapy requiring re-treatment every 4-6 weeks. All eyes had received four consecutive intravitreal injections of aflibercept 2 mg prior to switching to aflibercept 8 mg as part of routine clinical management. Functional outcome was assessed by distance-corrected visual acuity (DCVA). Anatomical outcomes included central retinal thickness (CRT), central subfield thickness (CST), and optical coherence tomography (OCT) features. Injection burden, responder status, discontinuation, and safety outcomes were evaluated. Follow-up occurred at 3, 6, 9, and 12 months.
RESULTS: Fifty patients (50 eyes) were included (mean age 78.4 ± 6.9 years; 60% female). Median baseline DCVA was 0.19 logMAR (IQR 0.12-0.32; 75.5 ETDRS letters), median CST 272 µm, and median CRT 338 µm. DCVA improved significantly at months 3, 6, and 9 (p ≤ 0.046) and remained stable at month 12. CRT and CST decreased early and remained improved. Over 12 months, 24 patients (48%) completed follow-up, while 26 (52%) discontinued early. Intraocular inflammation (IOI) occurred in 10 eyes (20%), corresponding to 3.0% per injection, and was temporally associated with off-label aliquoted preparation; all cases resolved without permanent visual loss. No further IOI events were observed after transition to on-label preparation. During safety evaluation, seven patients discontinued aflibercept 8 mg as a result of precautionary safety measures. Seventeen (34%) required ≤ 8 injections per year.
CONCLUSIONS: In chronically treated patients with nAMD requiring short re-treatment intervals, switching to aflibercept 8 mg was associated with modest anatomical improvement and stable visual function. A reduction in treatment burden was observed in a subset of patients, although overall durability remained heterogeneous and discontinuation rates were high. A cluster of sterile inflammatory events occurred during off-label aliquoted preparation, highlighting the importance of appropriate drug handling. Careful patient selection and strict adherence to on-label preparation procedures are essential to optimize safety. These findings should be interpreted cautiously given the exploratory design, lack of a comparator group, and high discontinuation rate.
TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT07390253.