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http://hdl.handle.net/2445/187948
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DC Field | Value | Language |
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dc.contributor.author | Silva, Rufino | - |
dc.contributor.author | Arias, Luis | - |
dc.contributor.author | Nunes, Sandrina | - |
dc.contributor.author | Farinha, Claudia | - |
dc.contributor.author | Coimbra, Rita | - |
dc.contributor.author | Maques, João P. | - |
dc.contributor.author | Cachulo, Maria L. | - |
dc.contributor.author | Figueira, João | - |
dc.contributor.author | Barreto, Patricia | - |
dc.contributor.author | Madeira, Maria H. | - |
dc.contributor.author | Pires, Isabel | - |
dc.contributor.author | Sousa, João C. | - |
dc.contributor.author | Distefano, Laura | - |
dc.contributor.author | Rosa, Paulo | - |
dc.contributor.author | Carneiro, Ângela | - |
dc.contributor.author | Vaz Pereira, Sara | - |
dc.contributor.author | Meireles, Angelina | - |
dc.contributor.author | Cabrera, Francisco | - |
dc.contributor.author | Bures, Anniken | - |
dc.contributor.author | Mendonça, Luís | - |
dc.contributor.author | Fernandez-Vega Sanz, Alvaro | - |
dc.contributor.author | Barrão, Sandra | - |
dc.contributor.author | Koh, Adrian | - |
dc.contributor.author | Cheung, Chui Ming Gemmy | - |
dc.contributor.author | Cunha Vaz, José G. | - |
dc.contributor.author | Murta, Joaquim | - |
dc.contributor.author | EVICR.net ATLANTIC Study Group | - |
dc.date.accessioned | 2022-07-22T15:35:48Z | - |
dc.date.available | 2022-07-22T15:35:48Z | - |
dc.date.issued | 2021-07-13 | - |
dc.identifier.uri | http://hdl.handle.net/2445/187948 | - |
dc.description.abstract | 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. | - |
dc.format.extent | 11 p. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | S. Karger AG | - |
dc.relation.isformatof | Reproducció del document publicat a: https://doi.org/10.1159/000518235 | - |
dc.relation.ispartof | Ophthalmologica, 2022, vol. 245, num. 1, p. 80-90 | - |
dc.relation.uri | https://doi.org/10.1159/000518235 | - |
dc.rights | cc by-nc (c) Silva, Rufino et al., 2021 | - |
dc.rights.uri | http://creativecommons.org/licenses/by-nc/3.0/es/ | * |
dc.source | Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) | - |
dc.subject.classification | Assaigs clínics | - |
dc.subject.classification | Pòlips (Patologia) | - |
dc.subject.classification | Malalties vasculars | - |
dc.subject.other | Clinical trials | - |
dc.subject.other | Polyps (Pathology) | - |
dc.subject.other | Vascular diseases | - |
dc.title | Efficacy and safety of Intravitreal Aflibercept Vs Verteporfin Photodynamic Therapy in a Caucasian Population with Polypoidal Choroidal Vasculopathy: A Randomized Clinical Trial | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/publishedVersion | - |
dc.date.updated | 2022-07-21T10:27:36Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
dc.identifier.pmid | 34348351 | - |
Appears in Collections: | Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
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