{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,16]],"date-time":"2026-04-16T01:32:03Z","timestamp":1776303123104,"version":"3.50.1"},"reference-count":30,"publisher":"S. Karger AG","issue":"1","license":[{"start":{"date-parts":[[2021,7,13]],"date-time":"2021-07-13T00:00:00Z","timestamp":1626134400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2021,7,13]],"date-time":"2021-07-13T00:00:00Z","timestamp":1626134400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Ophthalmologica"],"published-print":{"date-parts":[[2022]]},"abstract":"<b><i>Importance:<\/i><\/b> Polypoidal choroidal vasculopathy (PCV) is far less common and studied in a Caucasian population than in an Asian population, and the optimal treatment approach remains to be confirmed. <b><i>Methods:<\/i><\/b> A 52-week, double-masked, sham-controlled, phase 4, investigator-initiated randomized clinical trial (RCT) in naive symptomatic Caucasian patients with PCV treated with aflibercept in a treat-and-extend regimen (T&amp;E) (intravitreal aflibercept injection [IVAI] T&amp;E). Patients were randomized at week 16 to receive IVAI T&amp;E plus either sham photodynamic therapy (PDT) or standard fluence PDT with verteporfin. The main outcome measures were changes in best-corrected visual acuity (BCVA) from baseline to 52 weeks and polyp occlusion at week 52. Data are presented as median (interquartile range [IQR]) for BCVA, number of IVAI, and change in central retinal thickness (CRT). <b><i>Results:<\/i><\/b> Of the 50 patients included in the study, 48 patients completed the 52 weeks of follow-up. During this period, a significant median (IQR) BCVA gain of 6 [2\u201312] Early Treatment Diabetic Retinopathy Study letters was observed for all patients (<i>p<\/i> &#x3c; 0.001), after 8 (7\u20139) injections, with a significant reduction of \u221293.0 [\u2212154.0, \u221244.0] \u00b5m in central macular thickness (<i>p<\/i> &#x3c; 0.001). Using indocyanine green angiography, a complete occlusion of polypoidal lesions was documented in 72% of the cases. Still, no significant difference was detected between the sham PDT and the aflibercept PDT arms, at week 52, for BCVA change (6.5 [2\u201311] vs. 5 [2\u201313] letters (<i>p<\/i> = 0.98)), number of IVAIs (8.5 [7\u20139] vs. 8 [7\u20139] (<i>p<\/i> = 0.21)), change in CRT (\u2212143 [\u2212184; \u221247] vs. \u221289 [\u2212123; \u221241.5] \u00b5m [<i>p<\/i> = 0.23]), and rates of complete polyp occlusion: 77 versus 68% (<i>p<\/i> = 0.53) or presence of fluid: 68 versus 57% (<i>p<\/i> = 0.56). No serious ocular adverse events were registered in the 2 arms. <b><i>Conclusions and Relevance:<\/i><\/b> To our knowledge, this is the first RCT to compare aflibercept T&amp;E monotherapy with aflibercept T&amp;E plus verteporfin PDT in a Caucasian population with PCV. Aflibercept monotherapy in a T&amp;E showed to be effective and safe with a significant median BCVA improvement of 6 letters and a complete occlusion of polypoidal lesions in near 3 quarters of the eyes, at 1 year. As only 22% of the eyes underwent PDT treatment, the benefit of combined treatment for PCV in Caucasian patients could not be definitively elucidated from this study. <b><i>Trial Registration:<\/i><\/b> The clinical trial was registered in ClinicalTrials.gov Identifier NCT02495181 and the European Union Drug Regulating Authorities Clinical Trials Database EudraCT No. 2015-001368-20. <\/jats:p>","DOI":"10.1159\/000518235","type":"journal-article","created":{"date-parts":[[2021,7,13]],"date-time":"2021-07-13T21:00:37Z","timestamp":1626210037000},"page":"80-90","source":"Crossref","is-referenced-by-count":12,"title":["Efficacy and Safety of Intravitreal Aflibercept Treat and Extend for Polypoidal Choroidal Vasculopathy in the ATLANTIC Study: A Randomized Clinical Trial"],"prefix":"10.1159","volume":"245","author":[{"given":"Rufino","family":"Silva","sequence":"first","affiliation":[]},{"given":"Luis","family":"Arias","sequence":"additional","affiliation":[]},{"given":"Sandrina","family":"Nunes","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4596-0913","authenticated-orcid":false,"given":"Claudia","family":"Farinha","sequence":"additional","affiliation":[]},{"given":"Rita","family":"Coimbra","sequence":"additional","affiliation":[]},{"given":"Jo\u00e3o P.","family":"Marques","sequence":"additional","affiliation":[]},{"given":"Maria L.","family":"Cachulo","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3511-1515","authenticated-orcid":false,"given":"Jo\u00e3o","family":"Figueira","sequence":"additional","affiliation":[]},{"given":"Patricia","family":"Barreto","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6282-3553","authenticated-orcid":false,"given":"Maria H.","family":"Madeira","sequence":"additional","affiliation":[]},{"given":"Isabel","family":"Pires","sequence":"additional","affiliation":[]},{"given":"Jo\u00e3o C.","family":"Sousa","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2319-1324","authenticated-orcid":false,"given":"Laura","family":"Distefano","sequence":"additional","affiliation":[]},{"given":"Paulo","family":"Rosa","sequence":"additional","affiliation":[]},{"given":"\u00c2ngela","family":"Carneiro","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6125-5486","authenticated-orcid":false,"given":"Sara","family":"Vaz-Pereira","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9148-2786","authenticated-orcid":false,"given":"Angelina","family":"Meireles","sequence":"additional","affiliation":[]},{"given":"Francisco","family":"Cabrera","sequence":"additional","affiliation":[]},{"given":"Anniken","family":"Bures","sequence":"additional","affiliation":[]},{"given":"Lu\u00eds","family":"Mendon\u00e7a","sequence":"additional","affiliation":[]},{"given":"Alvaro","family":"Fernandez-Vega-Sanz","sequence":"additional","affiliation":[]},{"given":"Sandra","family":"Barr\u00e3o","sequence":"additional","affiliation":[]},{"given":"Adrian","family":"Koh","sequence":"additional","affiliation":[]},{"given":"Chui Ming Gemmy","family":"Cheung","sequence":"additional","affiliation":[]},{"given":"Jos\u00e9 G.","family":"Cunha-Vaz","sequence":"additional","affiliation":[]},{"given":"Joaquim","family":"Murta","sequence":"additional","affiliation":[]},{"name":"for the EVICR.net ATLANTIC Study 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