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      Recurrence of neovascular age-related macular degeneration after cessation of treat and extend regimen

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          Abstract

          The appropriate timing of treatment cessation after treat and extend (TAE) regimen for age-related macular degeneration has not been established. This study aimed to investigate the incidence and risk factors of recurrence after cessation of the TAE regimen. We included patients who received and discontinued the TAE regimen, after extension of the treatment interval to ≥ 12 weeks. Forty-nine patients were included in the study. The estimated recurrence rates were 33% at 1 year and 48% at 2 years after treatment cessation, respectively. Good visual acuity at cessation and a large number of injections in the 6 months before cessation were significant risk factors. Higher chances of recurrence were associated with < 0.1 logarithm of the minimum angle of resolution (logMAR) at cessation ( P < 0.002). Meanwhile, five patients with visual acuity ≥ 1.0 logMAR at cessation did not show recurrence. Among the 25 recurrences, two lines of vision loss were noted in only two cases after resumed treatment. This study confirmed the importance of the number of injections in reducing recurrence and the association between visual acuity and recurrence. Recurrence is generally well-controlled with resumed treatment.

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          Investigation of the freely available easy-to-use software ‘EZR' for medical statistics

          Y Kanda (2012)
          Although there are many commercially available statistical software packages, only a few implement a competing risk analysis or a proportional hazards regression model with time-dependent covariates, which are necessary in studies on hematopoietic SCT. In addition, most packages are not clinician friendly, as they require that commands be written based on statistical languages. This report describes the statistical software ‘EZR' (Easy R), which is based on R and R commander. EZR enables the application of statistical functions that are frequently used in clinical studies, such as survival analyses, including competing risk analyses and the use of time-dependent covariates, receiver operating characteristics analyses, meta-analyses, sample size calculation and so on, by point-and-click access. EZR is freely available on our website (http://www.jichi.ac.jp/saitama-sct/SaitamaHP.files/statmed.html) and runs on both Windows (Microsoft Corporation, USA) and Mac OS X (Apple, USA). This report provides instructions for the installation and operation of EZR.
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            Global causes of blindness and distance vision impairment 1990-2020: a systematic review and meta-analysis.

            Contemporary data for causes of vision impairment and blindness form an important basis of recommendations in public health policies. Refreshment of the Global Vision Database with recently published data sources permitted modelling of cause of vision loss data from 1990 to 2015, further disaggregation by cause, and forecasts to 2020.
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              Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration.

              Two similarly designed, phase-3 studies (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD [VIEW 1, VIEW 2]) of neovascular age-related macular degeneration (AMD) compared monthly and every-2-month dosing of intravitreal aflibercept injection (VEGF Trap-Eye; Regeneron, Tarrytown, NY, and Bayer HealthCare, Berlin, Germany) with monthly ranibizumab. Double-masked, multicenter, parallel-group, active-controlled, randomized trials. Patients (n = 2419) with active, subfoveal, choroidal neovascularization (CNV) lesions (or juxtafoveal lesions with leakage affecting the fovea) secondary to AMD. Patients were randomized to intravitreal aflibercept 0.5 mg monthly (0.5q4), 2 mg monthly (2q4), 2 mg every 2 months after 3 initial monthly doses (2q8), or ranibizumab 0.5 mg monthly (Rq4). The primary end point was noninferiority (margin of 10%) of the aflibercept regimens to ranibizumab in the proportion of patients maintaining vision at week 52 (losing <15 letters on Early Treatment Diabetic Retinopathy Study [ETDRS] chart). Other key end points included change in best-corrected visual acuity (BCVA) and anatomic measures. All aflibercept groups were noninferior and clinically equivalent to monthly ranibizumab for the primary end point (the 2q4, 0.5q4, and 2q8 regimens were 95.1%, 95.9%, and 95.1%, respectively, for VIEW 1, and 95.6%, 96.3%, and 95.6%, respectively, for VIEW 2, whereas monthly ranibizumab was 94.4% in both studies). In a prespecified integrated analysis of the 2 studies, all aflibercept regimens were within 0.5 letters of the reference ranibizumab for mean change in BCVA; all aflibercept regimens also produced similar improvements in anatomic measures. Ocular and systemic adverse events were similar across treatment groups. Intravitreal aflibercept dosed monthly or every 2 months after 3 initial monthly doses produced similar efficacy and safety outcomes as monthly ranibizumab. These studies demonstrate that aflibercept is an effective treatment for AMD, with the every-2-month regimen offering the potential to reduce the risk from monthly intravitreal injections and the burden of monthly monitoring. Proprietary or commercial disclosure may be found after the references. Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
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                Author and article information

                Contributors
                akio.oishi@nagasaki-u.ac.jp
                Journal
                Sci Rep
                Sci Rep
                Scientific Reports
                Nature Publishing Group UK (London )
                2045-2322
                30 August 2022
                30 August 2022
                2022
                : 12
                : 14768
                Affiliations
                [1 ]GRID grid.174567.6, ISNI 0000 0000 8902 2273, Department of Ophthalmology and Visual Sciences, Graduate School of Biomedical Sciences, , Nagasaki University, ; Sakamoto 1-7-1, Nagasaki, 852- 8102 Japan
                [2 ]Department of Ophthalmology, Japanese Red Cross Nagasaki Genbaku Hospital, Mori-machi, Nagasaki, 852-8511 Japan
                Article
                19062
                10.1038/s41598-022-19062-2
                9427844
                36042371
                98ef8d0c-c15c-4b51-a35e-dbeed23f2e36
                © The Author(s) 2022

                Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

                History
                : 1 July 2022
                : 24 August 2022
                Funding
                Funded by: Bayer Pharmaceutical, Japan
                Funded by: Novartis Pharma, Japan
                Funded by: Senju Pharmaceutical, Japan
                Funded by: Santen Pharmaceutical, Japan
                Funded by: Chugai Pharmaceutical, Japan
                Funded by: FundRef http://dx.doi.org/10.13039/501100001691, Japan Society for the Promotion of Science;
                Award ID: 22K09793
                Award Recipient :
                Funded by: ALCON JAPAN, Japan
                Funded by: Kowa Pharmaceutical, Japan
                Categories
                Article
                Custom metadata
                © The Author(s) 2022

                Uncategorized
                eye diseases,macular degeneration
                Uncategorized
                eye diseases, macular degeneration

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