Abstract
PurposeTo explore the relationship between retinal fluid status and best-corrected visual acuity (BCVA) in patients treated with intravitreal aflibercept (IVT-AFL) treat-and-extend (T&E) in the ALTAIR study.MethodsOutcomes were investigated according to overall fluid status at week 16 (predefined) and the relationship between any fluid, intraretinal fluid (IRF), subretinal fluid (SRF), or pigment epithelial detachment with BCVA at baseline, and weeks 16, 52, and 96 (post-hoc). The analyses involved treatment-naïve patients (N = 246) with exudative age-related macular degeneration (AMD), aged ≥ 50 years with BCVA of 73–25 Early Treatment Diabetic Retinopathy Study letters, who participated in the ALTAIR study.ResultsThe mean (standard deviation) change in BCVA from baseline to week 52 was + 10.6 (10.9) and + 6.5 (16.0) letters in patients without and with fluid at week 16, respectively; and to week 96 was + 9.1 (14.3) and + 4.3 (16.1) letters in patients without and with fluid at week 16, respectively. The last injection interval was 16 weeks in 33.6% and 2.0% (week 52), and 62.9% and 17.6% (week 96) of patients without or with fluid at week 16, respectively. At baseline, 35.7% of patients had IRF and 85.2% of patients had SRF, which decreased to 11.8% (IRF) and 31.7% (SRF) of patients, 8.5% (IRF) and 18.7% (SRF), and 6.5% (IRF) and 20.7% (SRF) at weeks 16, 52, and 96, respectively. Presence of IRF at all timepoints was associated with poorer BCVA than if IRF was absent, while the presence of SRF was not associated with poorer BCVA compared with the absence of SRF.ConclusionIVT-AFL T&E dosing was effective at clearing fluid regardless of fluid type in ~ 80% of patients with exudative AMD. Patients without fluid at week 16 had numerically better BCVA than those with fluid at week 16. Over 60% of patients without fluid at week 16 achieved the maximum treatment interval of 16 weeks by study end, compared with < 20% of patients with fluid at week 16. IRF (weeks 16, 52, 96), although evident in a small number of patients, was associated with poorer BCVA, whereas SRF was not.Trial registrationClinicalTrials.gov Identifier: NCT02305238
Highlights
Exudative age-related macular degeneration (AMD) is characterized by abnormal growth of new blood vessels in the macula [1] and is the leading cause of AMD-related vision loss [2]
85.2% of patients had intraretinal fluid (IRF) or subretinal fluid (SRF), which had reduced by week 16 to 11.8% and 31.7% of patients for the respective fluid compartment. In this predefined fluid analysis of data from the ALTAIR study, intravitreal aflibercept (IVT-AFL) T&E dosing was effective at clearing fluid and improving vision by week 16 in treatment-naïve patients with exudative AMD
BCVA, best-corrected visual acuity; confidence intervals (CIs), confidence interval; ETDRS, Early Treatment Diabetic Retinopathy Study; IVTAFL, intravitreal aflibercept; IVT-AFL-2 W, intravitreal aflibercept with 2-week adjustment; IVT-AFL-4 W, intravitreal aflibercept with 4-week adjustment; OCT, optical coherence tomography; SD, standard deviation treatment interval up to week 96, over 60% of patients without fluid at week 16 achieved the maximum treatment extension interval of 16 weeks, compared with 17.6% of patients with fluid at week 16
Summary
Exudative age-related macular degeneration (AMD) is characterized by abnormal growth of new blood vessels in the macula [1] and is the leading cause of AMD-related vision loss [2]. Clinical management of exudative AMD involves administering anti-vascular endothelial growth factor (VEGF) agents, such as aflibercept and ranibizumab [1], with the aim of improving functional and anatomic outcomes. Treat-and-extend (T&E) is a proactive, individualized dosing strategy whereby the treatment interval is gradually extended or shortened based on physician decision regarding the maintenance of functional and anatomic stability [4]. Results of the ALTAIR study demonstrated that, following initial monthly dosing, intravitreal aflibercept (IVT-AFL) administered in a T&E dosing regimen was effective in the first year of treatment and was continuously efficacious in the second year in patients with exudative AMD in Japan [5]. In the ALTAIR study, the criteria for injection interval shortening, maintenance, or extension were based on functional and anatomic outcomes (central retinal thickness [CRT], total fluid, intraretinal fluid [IRF], subretinal fluid [SRF], neovascularization, and hemorrhage) [5]
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