Efficacy and Safety of Intravitreal Aflibercept Treat and Extend for Polypoidal Choroidal Vasculopathy in the ATLANTIC Study: A Randomized Clinical Trial

Aflibercept; Efficacy; Polypoidal choroidal vasculopathy

Detalhes bibliográficos
Autores: Silva, Rufino, Nunes, Sandrina, Farinha, Cláudia, Coimbra, Rita, Marques, João P., Distefano, Laura Natalia, Arias, Luis
Tipo de documento: artigo
Estado:Versão publicada
Data de publicação:2021
País:España
Recursos:Departament de Salut de la Generalitat de Catalunya (DS)
Repositório:Scientia. Dipòsit d'Informació Digital del Departament de Salut
OAI Identifier:oai:scientiasalut.gencat.cat:11351/7822
Acesso em linha:https://hdl.handle.net/11351/7822
Access Level:Acceso aberto
Palavra-chave:Coroide - Malalties - Tractament
Fotoquimioteràpia
Avaluació de resultats (Assistència sanitària)
DISEASES::Eye Diseases::Uveal Diseases::Choroid Diseases
Other subheadings::Other subheadings::Other subheadings::/drug therapy
ENFERMEDADES::oftalmopatías::enfermedades de la úvea::enfermedades de la coroides
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
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oai_identifier_str oai:scientiasalut.gencat.cat:11351/7822
network_acronym_str ES
network_name_str España
repository_id_str
dc.title.none.fl_str_mv Efficacy and Safety of Intravitreal Aflibercept Treat and Extend for Polypoidal Choroidal Vasculopathy in the ATLANTIC Study: A Randomized Clinical Trial
title Efficacy and Safety of Intravitreal Aflibercept Treat and Extend for Polypoidal Choroidal Vasculopathy in the ATLANTIC Study: A Randomized Clinical Trial
spellingShingle Efficacy and Safety of Intravitreal Aflibercept Treat and Extend for Polypoidal Choroidal Vasculopathy in the ATLANTIC Study: A Randomized Clinical Trial
Silva, Rufino
Coroide - Malalties - Tractament
Fotoquimioteràpia
Avaluació de resultats (Assistència sanitària)
DISEASES::Eye Diseases::Uveal Diseases::Choroid Diseases
Other subheadings::Other subheadings::Other subheadings::/drug therapy
ENFERMEDADES::oftalmopatías::enfermedades de la úvea::enfermedades de la coroides
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
title_short Efficacy and Safety of Intravitreal Aflibercept Treat and Extend for Polypoidal Choroidal Vasculopathy in the ATLANTIC Study: A Randomized Clinical Trial
title_full Efficacy and Safety of Intravitreal Aflibercept Treat and Extend for Polypoidal Choroidal Vasculopathy in the ATLANTIC Study: A Randomized Clinical Trial
title_fullStr Efficacy and Safety of Intravitreal Aflibercept Treat and Extend for Polypoidal Choroidal Vasculopathy in the ATLANTIC Study: A Randomized Clinical Trial
title_full_unstemmed Efficacy and Safety of Intravitreal Aflibercept Treat and Extend for Polypoidal Choroidal Vasculopathy in the ATLANTIC Study: A Randomized Clinical Trial
title_sort Efficacy and Safety of Intravitreal Aflibercept Treat and Extend for Polypoidal Choroidal Vasculopathy in the ATLANTIC Study: A Randomized Clinical Trial
dc.creator.none.fl_str_mv Silva, Rufino
Nunes, Sandrina
Farinha, Cláudia
Coimbra, Rita
Marques, João P.
Distefano, Laura Natalia
Arias, Luis
author Silva, Rufino
author_facet Silva, Rufino
Nunes, Sandrina
Farinha, Cláudia
Coimbra, Rita
Marques, João P.
Distefano, Laura Natalia
Arias, Luis
author_role author
author2 Nunes, Sandrina
Farinha, Cláudia
Coimbra, Rita
Marques, João P.
Distefano, Laura Natalia
Arias, Luis
author2_role author
author
author
author
author
author
dc.contributor.none.fl_str_mv Institut Català de la Salut
[Silva R] Association of Innovation and Biomedical Research in Light and Image (AIBILI), Coimbra, Portugal. Ophthalmology Department, Centro Hospitalar e Universitário de Coimbra (CHUC), Coimbra, Portugal. Coimbra Institute for Clinical and Biomedical Research (iCBR), Faculty of Medicine, University of Coimbra, Coimbra, Portugal. Espaço Médico de Coimbra, Coimbra, Portugal. [Arias L] Bellvitge University Hospital, L’Hospitalet de Llobregat, Barcelona, Spain. [Nunes S] Association of Innovation and Biomedical Research in Light and Image (AIBILI), Coimbra, Portugal. Coimbra Institute for Clinical and Biomedical Research (iCBR), Faculty of Medicine, University of Coimbra, Coimbra, Portugal. [Farinha C, Marques JP] Association of Innovation and Biomedical Research in Light and Image (AIBILI), Coimbra, Portugal. Ophthalmology Department, Centro Hospitalar e Universitário de Coimbra (CHUC), Coimbra, Portugal. Coimbra Institute for Clinical and Biomedical Research (iCBR), Faculty of Medicine, University of Coimbra, Coimbra, Portugal. Clinical Academic Center of Coimbra (CACC), Coimbra, Portugal. [Coimbra R] Association of Innovation and Biomedical Research in Light and Image (AIBILI), Coimbra, Portugal. [Distefano L] Vall d’Hebron Hospital Universitari, Barcelona, Spain
Vall d'Hebron Barcelona Hospital Campus
dc.subject.none.fl_str_mv Coroide - Malalties - Tractament
Fotoquimioteràpia
Avaluació de resultats (Assistència sanitària)
DISEASES::Eye Diseases::Uveal Diseases::Choroid Diseases
Other subheadings::Other subheadings::Other subheadings::/drug therapy
ENFERMEDADES::oftalmopatías::enfermedades de la úvea::enfermedades de la coroides
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
topic Coroide - Malalties - Tractament
Fotoquimioteràpia
Avaluació de resultats (Assistència sanitària)
DISEASES::Eye Diseases::Uveal Diseases::Choroid Diseases
Other subheadings::Other subheadings::Other subheadings::/drug therapy
ENFERMEDADES::oftalmopatías::enfermedades de la úvea::enfermedades de la coroides
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
description Aflibercept; Efficacy; Polypoidal choroidal vasculopathy
publishDate 2021
dc.date.none.fl_str_mv 2021
2022
2022
2022
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/11351/7822
url https://hdl.handle.net/11351/7822
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Ophthalmologica;245(1)
https://doi.org/10.1159/000518235
dc.rights.none.fl_str_mv Attribution-NonCommercial 4.0 International
http://creativecommons.org/licenses/by-nc/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Attribution-NonCommercial 4.0 International
http://creativecommons.org/licenses/by-nc/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Karger
publisher.none.fl_str_mv Karger
dc.source.none.fl_str_mv Scientia
reponame:Scientia. Dipòsit d'Informació Digital del Departament de Salut
instname:Departament de Salut de la Generalitat de Catalunya (DS)
instname_str Departament de Salut de la Generalitat de Catalunya (DS)
reponame_str Scientia. Dipòsit d'Informació Digital del Departament de Salut
collection Scientia. Dipòsit d'Informació Digital del Departament de Salut
repository.name.fl_str_mv
repository.mail.fl_str_mv
_version_ 1869411067555217408
spelling Efficacy and Safety of Intravitreal Aflibercept Treat and Extend for Polypoidal Choroidal Vasculopathy in the ATLANTIC Study: A Randomized Clinical TrialSilva, RufinoNunes, SandrinaFarinha, CláudiaCoimbra, RitaMarques, João P.Distefano, Laura NataliaArias, LuisCoroide - Malalties - TractamentFotoquimioteràpiaAvaluació de resultats (Assistència sanitària)DISEASES::Eye Diseases::Uveal Diseases::Choroid DiseasesOther subheadings::Other subheadings::Other subheadings::/drug therapyENFERMEDADES::oftalmopatías::enfermedades de la úvea::enfermedades de la coroidesOtros calificadores::Otros calificadores::Otros calificadores::/farmacoterapiaAflibercept; Efficacy; Polypoidal choroidal vasculopathyAflibercept; Eficacia; Vasculopatía coroidea polipoideaAflibercept; Eficàcia; Vasculopatia coroidal polipoidalImportance: 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. Methods: 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&E) (intravitreal aflibercept injection [IVAI] T&E). Patients were randomized at week 16 to receive IVAI T&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). Results: 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 [2–12] Early Treatment Diabetic Retinopathy Study letters was observed for all patients (p < 0.001), after 8 (7–9) injections, with a significant reduction of −93.0 [−154.0, −44.0] µm in central macular thickness (p < 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 [2–11] vs. 5 [2–13] letters (p = 0.98)), number of IVAIs (8.5 [7–9] vs. 8 [7–9] (p = 0.21)), change in CRT (−143 [−184; −47] vs. −89 [−123; −41.5] µm [p = 0.23]), and rates of complete polyp occlusion: 77 versus 68% (p = 0.53) or presence of fluid: 68 versus 57% (p = 0.56). No serious ocular adverse events were registered in the 2 arms. Conclusions and Relevance: To our knowledge, this is the first RCT to compare aflibercept T&E monotherapy with aflibercept T&E plus verteporfin PDT in a Caucasian population with PCV. Aflibercept monotherapy in a T&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. Trial Registration: 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.Funding/support: This investigator-initiated study was financially supported by Bayer. Role of the funder/sponsor: Bayer had no role in the design and conduct of the study, collection, management, analysis, and interpretation of the data.KargerInstitut Català de la Salut[Silva R] Association of Innovation and Biomedical Research in Light and Image (AIBILI), Coimbra, Portugal. Ophthalmology Department, Centro Hospitalar e Universitário de Coimbra (CHUC), Coimbra, Portugal. Coimbra Institute for Clinical and Biomedical Research (iCBR), Faculty of Medicine, University of Coimbra, Coimbra, Portugal. Espaço Médico de Coimbra, Coimbra, Portugal. [Arias L] Bellvitge University Hospital, L’Hospitalet de Llobregat, Barcelona, Spain. [Nunes S] Association of Innovation and Biomedical Research in Light and Image (AIBILI), Coimbra, Portugal. Coimbra Institute for Clinical and Biomedical Research (iCBR), Faculty of Medicine, University of Coimbra, Coimbra, Portugal. [Farinha C, Marques JP] Association of Innovation and Biomedical Research in Light and Image (AIBILI), Coimbra, Portugal. Ophthalmology Department, Centro Hospitalar e Universitário de Coimbra (CHUC), Coimbra, Portugal. Coimbra Institute for Clinical and Biomedical Research (iCBR), Faculty of Medicine, University of Coimbra, Coimbra, Portugal. Clinical Academic Center of Coimbra (CACC), Coimbra, Portugal. [Coimbra R] Association of Innovation and Biomedical Research in Light and Image (AIBILI), Coimbra, Portugal. [Distefano L] Vall d’Hebron Hospital Universitari, Barcelona, SpainVall d'Hebron Barcelona Hospital Campus2022202220212022info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/11351/7822Scientiareponame:Scientia. Dipòsit d'Informació Digital del Departament de Salutinstname:Departament de Salut de la Generalitat de Catalunya (DS)InglésOphthalmologica;245(1)https://doi.org/10.1159/000518235Attribution-NonCommercial 4.0 Internationalhttp://creativecommons.org/licenses/by-nc/4.0/info:eu-repo/semantics/openAccessoai:scientiasalut.gencat.cat:11351/78222026-06-12T09:38:37Z
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