Efficacy and safety of Intravitreal Aflibercept Vs Verteporfin Photodynamic Therapy in a Caucasian Population with Polypoidal Choroidal Vasculopathy: A Randomized Clinical Trial

Importance: 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 clinica...

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Autores: Silva, Rufino, Arias, Luis, Nunes, Sandrina, Farinha, Claudia, Coimbra, Rita, Maques, João P., Cachulo, Maria L., Figueira, João, Barreto, Patricia, Madeira, Maria H., Pires, Isabel, Sousa, João C., Distefano, Laura, Rosa, Paulo, Carneiro, Ângela, Vaz Pereira, Sara, Meireles, Angelina, Cabrera, Francisco, Bures, Anniken, Mendonça, Luís, Fernandez-Vega Sanz, Alvaro, Barrão, Sandra, Koh, Adrian, Cheung, Chui Ming Gemmy, Cunha Vaz, José G., Murta, Joaquim, EVICR.net ATLANTIC Study Group
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2021
País:España
Institución:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositorio:Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:oai:recercat.cat:2445/187948
Acceso en línea:https://hdl.handle.net/2445/187948
Access Level:acceso abierto
Palabra clave:Assaigs clínics
Pòlips (Patologia)
Malalties vasculars
Clinical trials
Polyps (Pathology)
Vascular diseases
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spelling Efficacy and safety of Intravitreal Aflibercept Vs Verteporfin Photodynamic Therapy in a Caucasian Population with Polypoidal Choroidal Vasculopathy: A Randomized Clinical TrialSilva, RufinoArias, LuisNunes, SandrinaFarinha, ClaudiaCoimbra, RitaMaques, João P.Cachulo, Maria L.Figueira, JoãoBarreto, PatriciaMadeira, Maria H.Pires, IsabelSousa, João C.Distefano, LauraRosa, PauloCarneiro, ÂngelaVaz Pereira, SaraMeireles, AngelinaCabrera, FranciscoBures, AnnikenMendonça, LuísFernandez-Vega Sanz, AlvaroBarrão, SandraKoh, AdrianCheung, Chui Ming GemmyCunha Vaz, José G.Murta, JoaquimEVICR.net ATLANTIC Study GroupAssaigs clínicsPòlips (Patologia)Malalties vascularsClinical trialsPolyps (Pathology)Vascular diseasesImportance: 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] mu m 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] mu m [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.S. Karger AG2022202220212022info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion11 p.application/pdfhttps://hdl.handle.net/2445/187948Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))reponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésReproducció del document publicat a: https://doi.org/10.1159/000518235Ophthalmologica, 2022, vol. 245, num. 1, p. 80-90https://doi.org/10.1159/000518235cc by-nc (c) Silva, Rufino et al., 2021http://creativecommons.org/licenses/by-nc/3.0/es/info:eu-repo/semantics/openAccessoai:recercat.cat:2445/1879482026-05-29T05:05:01Z
dc.title.none.fl_str_mv Efficacy and safety of Intravitreal Aflibercept Vs Verteporfin Photodynamic Therapy in a Caucasian Population with Polypoidal Choroidal Vasculopathy: A Randomized Clinical Trial
title Efficacy and safety of Intravitreal Aflibercept Vs Verteporfin Photodynamic Therapy in a Caucasian Population with Polypoidal Choroidal Vasculopathy: A Randomized Clinical Trial
spellingShingle Efficacy and safety of Intravitreal Aflibercept Vs Verteporfin Photodynamic Therapy in a Caucasian Population with Polypoidal Choroidal Vasculopathy: A Randomized Clinical Trial
Silva, Rufino
Assaigs clínics
Pòlips (Patologia)
Malalties vasculars
Clinical trials
Polyps (Pathology)
Vascular diseases
title_short Efficacy and safety of Intravitreal Aflibercept Vs Verteporfin Photodynamic Therapy in a Caucasian Population with Polypoidal Choroidal Vasculopathy: A Randomized Clinical Trial
title_full Efficacy and safety of Intravitreal Aflibercept Vs Verteporfin Photodynamic Therapy in a Caucasian Population with Polypoidal Choroidal Vasculopathy: A Randomized Clinical Trial
title_fullStr Efficacy and safety of Intravitreal Aflibercept Vs Verteporfin Photodynamic Therapy in a Caucasian Population with Polypoidal Choroidal Vasculopathy: A Randomized Clinical Trial
title_full_unstemmed Efficacy and safety of Intravitreal Aflibercept Vs Verteporfin Photodynamic Therapy in a Caucasian Population with Polypoidal Choroidal Vasculopathy: A Randomized Clinical Trial
title_sort Efficacy and safety of Intravitreal Aflibercept Vs Verteporfin Photodynamic Therapy in a Caucasian Population with Polypoidal Choroidal Vasculopathy: A Randomized Clinical Trial
dc.creator.none.fl_str_mv Silva, Rufino
Arias, Luis
Nunes, Sandrina
Farinha, Claudia
Coimbra, Rita
Maques, João P.
Cachulo, Maria L.
Figueira, João
Barreto, Patricia
Madeira, Maria H.
Pires, Isabel
Sousa, João C.
Distefano, Laura
Rosa, Paulo
Carneiro, Ângela
Vaz Pereira, Sara
Meireles, Angelina
Cabrera, Francisco
Bures, Anniken
Mendonça, Luís
Fernandez-Vega Sanz, Alvaro
Barrão, Sandra
Koh, Adrian
Cheung, Chui Ming Gemmy
Cunha Vaz, José G.
Murta, Joaquim
EVICR.net ATLANTIC Study Group
author Silva, Rufino
author_facet Silva, Rufino
Arias, Luis
Nunes, Sandrina
Farinha, Claudia
Coimbra, Rita
Maques, João P.
Cachulo, Maria L.
Figueira, João
Barreto, Patricia
Madeira, Maria H.
Pires, Isabel
Sousa, João C.
Distefano, Laura
Rosa, Paulo
Carneiro, Ângela
Vaz Pereira, Sara
Meireles, Angelina
Cabrera, Francisco
Bures, Anniken
Mendonça, Luís
Fernandez-Vega Sanz, Alvaro
Barrão, Sandra
Koh, Adrian
Cheung, Chui Ming Gemmy
Cunha Vaz, José G.
Murta, Joaquim
EVICR.net ATLANTIC Study Group
author_role author
author2 Arias, Luis
Nunes, Sandrina
Farinha, Claudia
Coimbra, Rita
Maques, João P.
Cachulo, Maria L.
Figueira, João
Barreto, Patricia
Madeira, Maria H.
Pires, Isabel
Sousa, João C.
Distefano, Laura
Rosa, Paulo
Carneiro, Ângela
Vaz Pereira, Sara
Meireles, Angelina
Cabrera, Francisco
Bures, Anniken
Mendonça, Luís
Fernandez-Vega Sanz, Alvaro
Barrão, Sandra
Koh, Adrian
Cheung, Chui Ming Gemmy
Cunha Vaz, José G.
Murta, Joaquim
EVICR.net ATLANTIC Study Group
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Assaigs clínics
Pòlips (Patologia)
Malalties vasculars
Clinical trials
Polyps (Pathology)
Vascular diseases
topic Assaigs clínics
Pòlips (Patologia)
Malalties vasculars
Clinical trials
Polyps (Pathology)
Vascular diseases
description Importance: 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] mu m 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] mu m [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.
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/2445/187948
url https://hdl.handle.net/2445/187948
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Reproducció del document publicat a: https://doi.org/10.1159/000518235
Ophthalmologica, 2022, vol. 245, num. 1, p. 80-90
https://doi.org/10.1159/000518235
dc.rights.none.fl_str_mv cc by-nc (c) Silva, Rufino et al., 2021
http://creativecommons.org/licenses/by-nc/3.0/es/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv cc by-nc (c) Silva, Rufino et al., 2021
http://creativecommons.org/licenses/by-nc/3.0/es/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv 11 p.
application/pdf
dc.publisher.none.fl_str_mv S. Karger AG
publisher.none.fl_str_mv S. Karger AG
dc.source.none.fl_str_mv Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))
reponame:Recercat. Dipósit de la Recerca de Catalunya
instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
instname_str Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
reponame_str Recercat. Dipósit de la Recerca de Catalunya
collection Recercat. Dipósit de la Recerca de Catalunya
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15,811543

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