One-Year Outcomes of a Treat-and-Extend Regimen of Aflibercept for Exudative Age-Related Macular Degeneration

Yamamoto, Akiko; Okada, Annabelle A.; Nakayama, Makiko; Yoshida, Yumiko; Kobayashi, Hiroaki

doi:10.1159/000458538

Cited by 24 publications

(14 citation statements)

References 24 publications

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“…Our study demonstrated that an IVT-AFL T&E regimen, following initial monthly dosing, can be effective in the first year of treatment and continuously efficacious in the second year using either a 2-or 4-week adjustment based on defined criteria for interval extension, maintenance, or shortening. In other studies, injection intervals were adjusted by 2-week increments with a set minimum injection interval of 4 weeks and a maximum of 12 weeks [21][22][23]. In ALTAIR, 57-60% of patients achieved a last injection interval of at least 12 weeks up to week 96, compared with 17-37% of patients in other prospective studies of ranibizumab and IVT-AFL T&E regimens [21,[24][25][26].…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Intravitreal Aflibercept Treat-and-Extend Regimens in Exudative Age-Related Macular Degeneration: 52- and 96-Week Findings from ALTAIR

et al. 2020

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Purpose: To evaluate efficacy and safety of intravitreal injections of aflibercept (IVT-AFL) treat-and-extend (T&E) dosing regimens in treatment-naïve patients with exudative agerelated macular degeneration (AMD).Methods: Adults aged at least 50 years old with exudative AMD and best-corrected visual acuity (BCVA) of 73-25 Early Treatment Diabetic Retinopathy Study (ETDRS) letters were included. Patients received three monthly doses of IVT-AFL 2 mg. At week 16, patients were randomized 1:1 to IVT-AFL T&E with either 2-or 4-week adjustments. The primary endpoint was mean change in BCVA from baseline to week 52. Outcomes were assessed at weeks 52 and 96. Results: Baseline characteristics were comparable between the groups (n = 123 each). Over 52 weeks, mean number of injections was 7.2 and 6.9 and mean last injection interval was 10.7 and 11.8 weeks, for the 2-and 4-week groups, respectively. From baseline, mean change in BCVA was ? 9.0 and ? 8.4 letters (week 52) and ? 7.6 and ? 6.1 letters (week 96); mean change in central retinal thickness was -134.4 lm and -126.1 lm (week 52) and -130.5 lm and -125.3 lm (week 96). Last injection interval before week 52 was at least 12 weeks in 42.3% and 49.6% of patients and 56.9% and 60.2% before week 96. Over 96 weeks, mean number of injections was 10.4 (both groups). The safety profile of IVT-AFL was consistent with previous reports. Conclusions: IVT-AFL administered using two different T&E regimens for treatment-naïve exudative AMD improved functional and anatomic outcomes at week 52 and outcomes were Enhanced Digital Features To view enhanced digital features for this article go to https://doi.org/10.6084/ m9.figshare.11603511.maintained to week 96. Outcomes were similar between the 2-and 4-week groups. Trial Registration: ClinicalTrials.gov identifier, NCT02305238. Key Summary PointsWhy carry out this study?The goal of proactive flexible treat-andextend (T&E) regimens is to reduce the treatment burden associated with antivascular endothelial growth factor (VEGF) therapy, while maintaining a patient's visual acuity gains.The aim of this study was to evaluate the efficacy and safety of intravitreal aflibercept (IVT-AFL) T&E dosing regimens in treatment-naïve patients with exudative age-related macular degeneration (AMD).What was learned from the study?IVT-AFL administered using either 2-or 4-week adjustment T&E regimens in treatment-naïve patients with exudative AMD improved functional (best-corrected visual acuity ? 9.0 and ? 8.4 letters) and anatomic outcomes (central retinal thickness -134.4 and -126.1 lm) at 52 weeks; functional and anatomic outcomes were maintained over 96 weeks.A large proportion of patients (35.1% and 40.5%) had an intended injection interval of 16 weeks at week 52.The incidence of treatment-emergent adverse events was consistent with the known safety profile of IVT-AFL.IVT-AFL T&E regimens were efficacious and safe over 96 weeks of treatment using either 2-or 4-week adjustments.

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Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Intravitreal Aflibercept Treat-and-Extend Regimens in Exudative Age-Related Macular Degeneration: 52- and 96-Week Findings from ALTAIR

et al. 2020

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“… 8 , 23 , 24 In the VIEW studies, monthly and bimonthly aflibercept treatment after 3 loading doses resulted in 8-9 letters of visual increase at month 12. 8 Yamamoto et al 25 evaluated the efficacy of treat-and-extend regimen with aflibercept in nAMD and demonstrated 1.5 lines of visual increase at month 12. In all of these and other randomized controlled studies, the mean injection number during the first year was reported as at least 8.…”

Section: Discussionmentioning

confidence: 99%

“…In all of these and other randomized controlled studies, the mean injection number during the first year was reported as at least 8. 6 , 8 , 12 , 23 , 24 , 25 On the other hand, reaching this injection number seems nearly impossible with the PRN treatment regimen in real life. 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 Most of the retrospective real-life studies reported the injection number as 3-4 during the first year.…”

Section: Discussionmentioning

confidence: 99%

Real-World Outcomes of Anti-VEGF Treatment for Neovascular Age-Related Macular Degeneration in Turkey: A Multicenter Retrospective Study, Bosphorus Retina Study Group Report No: 1

Özkaya

Karabaş

Alagöz

et al. 2018

tjo

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Objectives:To evaluate the real-world outcomes of intravitreal anti-vascular endothelial growth factor (anti-VEGF) treatment in neovascular age-related macular degeneration (nAMD) patients.Materials and Methods:Multicenter, retrospective, interventional, non-comparative study. The records of nAMD patients treated with an anti-VEGF agent on a pro re nata treatment regimen basis between January 2013 and December 2015 were reviewed. The patients who completed a follow-up period of 12 months were included. Primary outcome measures of this study were the visit and injection numbers during the first year.Results:Eight hundred eighty eyes of 783 patients met the inclusion criteria for the study. Mean number of visits at month 12 was 6.9±2.5 (range: 1-15). Mean number of injections at month 12 was 4.1±1.9 (range: 1-11). Mean visual acuity at baseline and months 3, 6, and 12 was 0.90±0.63 LogMAR (range: 0.0-3.0), 0.79±0.57 LogMAR (range: 0.0-3.0), 0.76±0.57 LogMAR (range: 0.0-3.0), and 0.79±0.59 LogMAR (range: 0.0-3.0), respectively. Mean central retinal thickness at baseline and months 6 and 12 was 395±153 μm (range: 91-1582), 330±115 μm (range: 99-975), and 332±114 μm (range: 106-1191), respectively.Conclusion:The numbers of visits and injections were much lower than ideal and were insufficient with the pro re nata treatment regimen.

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“…In real-world practice, the majority of patients with AMD are given pro re nata or treat-and-extend (TAE) regimens to reduce various physical and financial burdens on both the patients and physicians,19–22 and a TAE dosing regimen showed similar visual outcomes with less injection numbers compared to fixed-dosing regimens 23…”

Section: Introductionmentioning

confidence: 99%

Two-year outcome of treat-and-extend aflibercept after ranibizumab in age-related macular degeneration and polypoidal choroidal vasculopathy patients

Azuma¹,

Asaoka²,

Matsuda³

et al. 2018

OPTH

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BackgroundThe purpose of the study was to evaluate the 2-year outcome and predictive factors of treat-and-extend aflibercept in patients with eyes affected by typical neovascular age-related macula degenelation (t-AMD) or polypoidal choroidal vasculopathy (PCV), who were switched from ranibizumab.Patients and methodsThe patients underwent three monthly aflibercept injections and subsequent administration following the treat-and-extend protocol. Sixty-two eyes of 62 patients were reviewed retrospectively. R statistical software was used for statistical analysis.ResultsTwenty-two eyes were t-AMD and the remaining 40 eyes were PCV. There was no significant difference in the logarithm of the minimal angle of resolution visual acuity (VA) between baseline and 2 years after switching to aflibercept (0.40 vs 0.40; P=0.99). Multivariate analyses suggested that the following factors were significantly correlated with better VA at 2 years after switching to aflibercept: patients with PCV, the absence of intraretinal fluid at baseline, and better VA at baseline.ConclusionIn conclusion, VA was maintained and there was an anatomical improvement at 2 years in patients with t-AMD and PCV who were switched from ranibizumab to treat-and-extend aflibercept. PCV patients showed more favorable visual outcomes and less injections at 2 years compared to t-AMD patients. Intraretinal fluid and VA at baseline were predictors of VA at 2 years.

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One-Year Outcomes of a Treat-and-Extend Regimen of Aflibercept for Exudative Age-Related Macular Degeneration

Cited by 24 publications

References 24 publications

Efficacy and Safety of Intravitreal Aflibercept Treat-and-Extend Regimens in Exudative Age-Related Macular Degeneration: 52- and 96-Week Findings from ALTAIR

Efficacy and Safety of Intravitreal Aflibercept Treat-and-Extend Regimens in Exudative Age-Related Macular Degeneration: 52- and 96-Week Findings from ALTAIR

Real-World Outcomes of Anti-VEGF Treatment for Neovascular Age-Related Macular Degeneration in Turkey: A Multicenter Retrospective Study, Bosphorus Retina Study Group Report No: 1

Two-year outcome of treat-and-extend aflibercept after ranibizumab in age-related macular degeneration and polypoidal choroidal vasculopathy patients

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