ABSTRACT
PURPOSE: To investigate factors associated with macular atrophy (MA) incidence in neovascular age-related macular degeneration treated with either ranibizumab or aflibercept in an Observe-and-Plan variable dosing regimen. METHODS: Information was obtained from two identical prospective treatment protocols using ranibizumab or aflibercept in a variable dosing regimen termed "Observe and Plan." Eyes without MA at baseline were included. New atrophy at the final 2-year visit was investigated with univariate and multivariate analysis to identify associated risk factors, focusing on treatment factors. RESULTS: De novo MA developed in 63 (42%) of 149 eyes/patients (mean age 79.0 years), in 70 eyes treated using aflibercept and 79 eyes using ranibizumab. The univariate analysis showed multiple associations of MA with baseline factors, of which the following were confirmed as independent risk factors after multivariate stepwise logistic regression: lower number of anti-vascular endothelial growth factors injections (P = 0.011), depigmentation (P = 0.0004), reticular pseudodrusen (P = 0.0005), lower baseline visual acuity (P = 0.0006), and retinal angiomatous proliferation (P = 0.001). The drug type showed no significant association with MA incidence (P = 0.21). CONCLUSION: Within the variable dosing regimen, MA incidence was higher when fewer injections were required. More injections, if required by disease activity, did not increase the risk for MA.
Subject(s)
Macula Lutea/pathology , Ranibizumab/adverse effects , Recombinant Fusion Proteins/adverse effects , Visual Acuity , Wet Macular Degeneration/drug therapy , Aged , Angiogenesis Inhibitors/administration & dosage , Angiogenesis Inhibitors/adverse effects , Atrophy/chemically induced , Atrophy/diagnosis , Atrophy/epidemiology , Disease Progression , Dose-Response Relationship, Drug , Female , Fluorescein Angiography , Fundus Oculi , Humans , Incidence , Intravitreal Injections , Macula Lutea/drug effects , Male , Prognosis , Prospective Studies , Ranibizumab/administration & dosage , Receptors, Vascular Endothelial Growth Factor/administration & dosage , Receptors, Vascular Endothelial Growth Factor/antagonists & inhibitors , Recombinant Fusion Proteins/administration & dosage , Risk Factors , Switzerland/epidemiology , Tomography, Optical Coherence , Wet Macular Degeneration/diagnosisABSTRACT
PURPOSE: The purpose of our study was to investigate the two-year outcome of Aflibercept treatment for neovascular age-related macular degeneration (nAMD), using the Observe-and-Plan regimen, an individually planned treatment regimen, based on the predictability of an individual's need for retreatment, aiming to reduce the clinical burden. METHODS: Our prospective study used the Observe-and-Plan regimen with Aflibercept to treat nAMD: Three loading doses, followed by monthly observation visits until the disease-recurrence interval was determined, which then was shortened by 2 weeks in a treatment plan for the next three injections without intermediate monitoring visits. The subsequent treatment plans were adjusted according to periodically assessed disease activity. The primary outcome measures were visual acuity changes, number of injections, and number of monitoring visits. RESULTS: The study included 112 eyes of 102 patients with a mean age of 80.7 years (SD 7.6). Mean visual acuity (VA) improved from 61.8 ETDRS letters (20/60+2) at baseline, by 8.5, 8.0, and 6.2 letters at months 3, 12 and 24, respectively. Mean central retinal thickness was 438um at baseline, and reduced by 152um, 155um, and 150um at months 3, 12 and 24, respectively. The mean number of injections was 8.7 and 6.5 in the first and second year, respectively. The mean number of monitoring visits after baseline was 3.8 and 2.8 during the first and second year, respectively. CONCLUSIONS: The Observe-and-Plan regimen significantly improved VA, while fewer monitoring visits were needed as compared to other variable dosing regimens, thus reducing the workload for chronic care management of nAMD.
