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Brolucizumab Intravitreal Injections for Wet Age-Related Macular Degeneration: Real-Life Study on a Cohort of Italian Patients

Background and Objectives: To report the real-life Brolucizumab therapeutical outcomes of treatment-naïve and non-treatment-naïve eyes with neovascular age-related macular degeneration (nAMD) and to analyze the incidence of therapy-related adverse events. Materials and Methods: A total of 56 eyes of...

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Autores principales: Gesualdo, Carlo, Rossi, Settimio, Iodice, Clemente Maria, Guarino, Francesco, Petrella, Mariachiara, D’Agostino, Fabiana Anna, Perrotta, Raffaele, Simonelli, Francesca
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10304196/
https://www.ncbi.nlm.nih.gov/pubmed/37374314
http://dx.doi.org/10.3390/medicina59061110
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author Gesualdo, Carlo
Rossi, Settimio
Iodice, Clemente Maria
Guarino, Francesco
Petrella, Mariachiara
D’Agostino, Fabiana Anna
Perrotta, Raffaele
Simonelli, Francesca
author_facet Gesualdo, Carlo
Rossi, Settimio
Iodice, Clemente Maria
Guarino, Francesco
Petrella, Mariachiara
D’Agostino, Fabiana Anna
Perrotta, Raffaele
Simonelli, Francesca
author_sort Gesualdo, Carlo
collection PubMed
description Background and Objectives: To report the real-life Brolucizumab therapeutical outcomes of treatment-naïve and non-treatment-naïve eyes with neovascular age-related macular degeneration (nAMD) and to analyze the incidence of therapy-related adverse events. Materials and Methods: A total of 56 eyes of 54 patients diagnosed with nAMD were retrospectively evaluated over a 3-month follow-up. Naïve eyes received a 3-month loading phase, whereas non-naïve eyes were treated with one intravitreal injection + ProReNata scheme. The main outcome measures were best-corrected visual acuity (BCVA) and central retinal thickness (CRT) change. In addition, patients were stratified on the basis of fluid accumulation site, whether intra-retinal (IRF), sub-retinal (SRF), or sub-retinal pigmented epithelium (SRPE), to separately assess the eventual BCVA change in each subgroup. Finally, the incidence of ocular adverse events was evaluated. Results: In naïve eyes, a significant improvement of BCVA (LogMar) was observed at all timepoints from baseline (1 month-Mean Difference (MD): −0.13; 2 months MD: −0.17; 3 months MD: −0.24). In non-naïve eyes, a significant mean change was observed at all timepoints, with the exception of 1-month follow-up (2 months MD: −0.08; 3 months MD: −0.05). CRT significantly changed in both groups at all timepoints at a similar pace within the first two months, with naïve eyes displaying a larger overall thickness decrease at the end of the follow-up (Group 1 = MD: −123.91 µm; Group 2 = MD: −110.33 µm). With respect to the location of the edema, a significant BCVA change was observed in naïve patients with fluid in all three sites at the end of the follow-up (SRPE = MD: −0.13 (p = 0.043); SR = MD: −0.15 (p = 0.019); IR = MD: −0.19 (p = 0.041). Non-naïve patients exhibited significant mean BCVA changes only with respect to SR and IR fluid presence (SRPE = MD: −0.13 (p = 0.152); SR = MD: −0.15 (p = 0.007); IR = MD: −0.06 (p = 0.011). One naïve patient experienced acute-onset anterior and intermediate uveitis which completely resolved after therapy. Conclusions: Brolucizumab was demonstrated to be a safe and efficient alternative in improving both the anatomical and functional parameters of eyes with nAMD in this small, uncontrolled, series of patients.
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spelling pubmed-103041962023-06-29 Brolucizumab Intravitreal Injections for Wet Age-Related Macular Degeneration: Real-Life Study on a Cohort of Italian Patients Gesualdo, Carlo Rossi, Settimio Iodice, Clemente Maria Guarino, Francesco Petrella, Mariachiara D’Agostino, Fabiana Anna Perrotta, Raffaele Simonelli, Francesca Medicina (Kaunas) Article Background and Objectives: To report the real-life Brolucizumab therapeutical outcomes of treatment-naïve and non-treatment-naïve eyes with neovascular age-related macular degeneration (nAMD) and to analyze the incidence of therapy-related adverse events. Materials and Methods: A total of 56 eyes of 54 patients diagnosed with nAMD were retrospectively evaluated over a 3-month follow-up. Naïve eyes received a 3-month loading phase, whereas non-naïve eyes were treated with one intravitreal injection + ProReNata scheme. The main outcome measures were best-corrected visual acuity (BCVA) and central retinal thickness (CRT) change. In addition, patients were stratified on the basis of fluid accumulation site, whether intra-retinal (IRF), sub-retinal (SRF), or sub-retinal pigmented epithelium (SRPE), to separately assess the eventual BCVA change in each subgroup. Finally, the incidence of ocular adverse events was evaluated. Results: In naïve eyes, a significant improvement of BCVA (LogMar) was observed at all timepoints from baseline (1 month-Mean Difference (MD): −0.13; 2 months MD: −0.17; 3 months MD: −0.24). In non-naïve eyes, a significant mean change was observed at all timepoints, with the exception of 1-month follow-up (2 months MD: −0.08; 3 months MD: −0.05). CRT significantly changed in both groups at all timepoints at a similar pace within the first two months, with naïve eyes displaying a larger overall thickness decrease at the end of the follow-up (Group 1 = MD: −123.91 µm; Group 2 = MD: −110.33 µm). With respect to the location of the edema, a significant BCVA change was observed in naïve patients with fluid in all three sites at the end of the follow-up (SRPE = MD: −0.13 (p = 0.043); SR = MD: −0.15 (p = 0.019); IR = MD: −0.19 (p = 0.041). Non-naïve patients exhibited significant mean BCVA changes only with respect to SR and IR fluid presence (SRPE = MD: −0.13 (p = 0.152); SR = MD: −0.15 (p = 0.007); IR = MD: −0.06 (p = 0.011). One naïve patient experienced acute-onset anterior and intermediate uveitis which completely resolved after therapy. Conclusions: Brolucizumab was demonstrated to be a safe and efficient alternative in improving both the anatomical and functional parameters of eyes with nAMD in this small, uncontrolled, series of patients. MDPI 2023-06-08 /pmc/articles/PMC10304196/ /pubmed/37374314 http://dx.doi.org/10.3390/medicina59061110 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Gesualdo, Carlo
Rossi, Settimio
Iodice, Clemente Maria
Guarino, Francesco
Petrella, Mariachiara
D’Agostino, Fabiana Anna
Perrotta, Raffaele
Simonelli, Francesca
Brolucizumab Intravitreal Injections for Wet Age-Related Macular Degeneration: Real-Life Study on a Cohort of Italian Patients
title Brolucizumab Intravitreal Injections for Wet Age-Related Macular Degeneration: Real-Life Study on a Cohort of Italian Patients
title_full Brolucizumab Intravitreal Injections for Wet Age-Related Macular Degeneration: Real-Life Study on a Cohort of Italian Patients
title_fullStr Brolucizumab Intravitreal Injections for Wet Age-Related Macular Degeneration: Real-Life Study on a Cohort of Italian Patients
title_full_unstemmed Brolucizumab Intravitreal Injections for Wet Age-Related Macular Degeneration: Real-Life Study on a Cohort of Italian Patients
title_short Brolucizumab Intravitreal Injections for Wet Age-Related Macular Degeneration: Real-Life Study on a Cohort of Italian Patients
title_sort brolucizumab intravitreal injections for wet age-related macular degeneration: real-life study on a cohort of italian patients
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10304196/
https://www.ncbi.nlm.nih.gov/pubmed/37374314
http://dx.doi.org/10.3390/medicina59061110
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