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Clinical outcomes of a treat and extend regimen with intravitreal aflibercept injections in patients with diabetic macular edema: Experience in clinical practice


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Curry, BA, Sanfilippo, PG, Chan, S, Hewitt, AW ORCID: 0000-0002-5123-5999 and Verma, N 2020 , 'Clinical outcomes of a treat and extend regimen with intravitreal aflibercept injections in patients with diabetic macular edema: Experience in clinical practice' , Ophthalmology and Therapy, vol. 9, no. 1 , pp. 87-101 , doi: 10.1007/s40123-019-00224-x.

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Introduction: Treat-and-extend (T&E) and prore nata (PRN; ‘as needed’) regimens of intravitreal anti-vascular endothelial growth factor(VEGF) treatment have been found to reducethe injection burden on patients and improvethe cost effectiveness of the treatment of macular edema. The aim of this study was to assessthe effectiveness of a T&E regimen of aflibercept, in a clinical setting, in patients with diabetic macular edema (DME) who were either intravitreal anti-VEGF therapy naive or withminimal exposure to anti-VEGF (B 6 treatments) in the previous 12 months.Methods: This prospective, single arm, open labelstudy recruited patients with DME (macularthickness of C 300 lm) and best-corrected visualacuity (BCVA) between 28-78 ETDRS letters. Participants received five loading doses of intravitrealaflibercept at 4-weekly intervals. BCVA measurements and macular optical coherence tomographywere performed at each visit. If no disease activitywas detected, treatment intervals were increased by2 weeks to a maximum of 12 weeks. Outcomemeasures included: changes in BCVA and retinalanatomical measures (central foveal thickness[CFT] and central macular volume within 6 mm ofthe fovea [CSVol]) between baseline and 2 years,patient treatment intervals; and adverse events.Results: Of the 36 patients who providedinformed consent to participate in the studyand were screened, 26 patients (eyes) were eligible to participate in the study. After regressionanalysis, adjustment for repeated measures, andsignificant covariates, the mean BCVA increasedby 3.8 letters (95% confidence interval [CI] 1.1,6.4) and the CFT and CSVol decreased by127.2 lm (95% CI 91.7, 162.5) and 1.6 mm3 (95% CI 1.2, 2.0), respectively, over the courseof the study. In the second year, 16 of the 25patients still participating had their treatmentintervals extended to 12 weeks. There was noevidence of any new adverse events that wouldrequire changes to the aflibercept safety profile.Conclusion: For the majority of patients presenting with DME, a T&E regimen of afliberceptin the first 2 years of therapy is a practical alternative to PRN treatment with regular review.

Item Type: Article
Authors/Creators:Curry, BA and Sanfilippo, PG and Chan, S and Hewitt, AW and Verma, N
Keywords: aflibercept, anti-vascular endothelial growth factor, clinical setting, diabetic macular oedema, treat and extend
Journal or Publication Title: Ophthalmology and Therapy
Publisher: Adis International Ltd.
ISSN: 2193-8245
DOI / ID Number: 10.1007/s40123-019-00224-x
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Copyright The Author(s) 2019 This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (, which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

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