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Short-Term Treatment Outcomes of Brolucizumab in Patients with Neovascular Age-Related Macular Degeneration: A Multicentre Indian Real-World Evidence Study

OBJECTIVE: To evaluate the short-term effectiveness and safety outcomes following brolucizumab treatment in patients with neovascular age-related macular degeneration (nAMD) as a part of real-world clinical practice in India. METHODS: This was a retrospective, observational, multicentre study includ...

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Autores principales: Chakraborty, Debdulal, Thakkar, Milan, Venkatesh, Ramesh, Roy, Sangeeta, Bhavsar, Maulik, Karcher, Helene
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10424695/
https://www.ncbi.nlm.nih.gov/pubmed/37583576
http://dx.doi.org/10.2147/OPTH.S415044
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author Chakraborty, Debdulal
Thakkar, Milan
Venkatesh, Ramesh
Roy, Sangeeta
Bhavsar, Maulik
Karcher, Helene
author_facet Chakraborty, Debdulal
Thakkar, Milan
Venkatesh, Ramesh
Roy, Sangeeta
Bhavsar, Maulik
Karcher, Helene
author_sort Chakraborty, Debdulal
collection PubMed
description OBJECTIVE: To evaluate the short-term effectiveness and safety outcomes following brolucizumab treatment in patients with neovascular age-related macular degeneration (nAMD) as a part of real-world clinical practice in India. METHODS: This was a retrospective, observational, multicentre study including patients (≥50 years old) diagnosed with nAMD. Anonymized data of the patients receiving the first dose of brolucizumab intravitreal injection (IVI) who were either treatment-naïve or previously treated with a single or a combination of other anti-VEGF IVIs were included. The present study reported the change in retinal fluid levels from baseline to month 3, best-corrected visual acuity (BCVA), central retinal thickness (CRT), and the number of injections received. The adverse events in the three months after brolucizumab treatment initiation were also monitored. RESULTS: The study included 63 patients (65 eyes) from four study centres across India (mean age: 69.1 ± 9.7 years). A total of 82 brolucizumab injections were administered during the 3 months of study duration, with 52/65 (80.0%) eyes receiving only 1 injection. Resolution of IRF, SRF, and PED was observed in 76.9%, 64.6%, and 67.7% of eyes, respectively. Further, a significant reduction in CRT was observed (baseline: 403.5 ± 118.7 μm; month 3: 308.3 ± 73.8 μm; p < 0.001), and BCVA also improved notably from 0.7 ± 0.5 logMAR at baseline to 0.5 ± 0.4 logMAR at month 3 (p < 0.001). Adverse events (AEs) were reported in 3 eyes from 3 patients; retinal pigment epithelial rip (1) and subretinal hemorrhage (2) after the first injection of brolucizumab, however, none discontinued the treatment. CONCLUSION: The study reports on the short-term effectiveness and tolerability of brolucizumab therapy in the management of nAMD in both treatment-naïve and switch eyes. Brolucizumab was observed to have a favourable benefit-risk profile, and study results were within the known safety profile, with no instances of intraocular inflammation.
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spelling pubmed-104246952023-08-15 Short-Term Treatment Outcomes of Brolucizumab in Patients with Neovascular Age-Related Macular Degeneration: A Multicentre Indian Real-World Evidence Study Chakraborty, Debdulal Thakkar, Milan Venkatesh, Ramesh Roy, Sangeeta Bhavsar, Maulik Karcher, Helene Clin Ophthalmol Original Research OBJECTIVE: To evaluate the short-term effectiveness and safety outcomes following brolucizumab treatment in patients with neovascular age-related macular degeneration (nAMD) as a part of real-world clinical practice in India. METHODS: This was a retrospective, observational, multicentre study including patients (≥50 years old) diagnosed with nAMD. Anonymized data of the patients receiving the first dose of brolucizumab intravitreal injection (IVI) who were either treatment-naïve or previously treated with a single or a combination of other anti-VEGF IVIs were included. The present study reported the change in retinal fluid levels from baseline to month 3, best-corrected visual acuity (BCVA), central retinal thickness (CRT), and the number of injections received. The adverse events in the three months after brolucizumab treatment initiation were also monitored. RESULTS: The study included 63 patients (65 eyes) from four study centres across India (mean age: 69.1 ± 9.7 years). A total of 82 brolucizumab injections were administered during the 3 months of study duration, with 52/65 (80.0%) eyes receiving only 1 injection. Resolution of IRF, SRF, and PED was observed in 76.9%, 64.6%, and 67.7% of eyes, respectively. Further, a significant reduction in CRT was observed (baseline: 403.5 ± 118.7 μm; month 3: 308.3 ± 73.8 μm; p < 0.001), and BCVA also improved notably from 0.7 ± 0.5 logMAR at baseline to 0.5 ± 0.4 logMAR at month 3 (p < 0.001). Adverse events (AEs) were reported in 3 eyes from 3 patients; retinal pigment epithelial rip (1) and subretinal hemorrhage (2) after the first injection of brolucizumab, however, none discontinued the treatment. CONCLUSION: The study reports on the short-term effectiveness and tolerability of brolucizumab therapy in the management of nAMD in both treatment-naïve and switch eyes. Brolucizumab was observed to have a favourable benefit-risk profile, and study results were within the known safety profile, with no instances of intraocular inflammation. Dove 2023-08-10 /pmc/articles/PMC10424695/ /pubmed/37583576 http://dx.doi.org/10.2147/OPTH.S415044 Text en © 2023 Chakraborty et al. https://creativecommons.org/licenses/by-nc/3.0/This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/ (https://creativecommons.org/licenses/by-nc/3.0/) ). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php).
spellingShingle Original Research
Chakraborty, Debdulal
Thakkar, Milan
Venkatesh, Ramesh
Roy, Sangeeta
Bhavsar, Maulik
Karcher, Helene
Short-Term Treatment Outcomes of Brolucizumab in Patients with Neovascular Age-Related Macular Degeneration: A Multicentre Indian Real-World Evidence Study
title Short-Term Treatment Outcomes of Brolucizumab in Patients with Neovascular Age-Related Macular Degeneration: A Multicentre Indian Real-World Evidence Study
title_full Short-Term Treatment Outcomes of Brolucizumab in Patients with Neovascular Age-Related Macular Degeneration: A Multicentre Indian Real-World Evidence Study
title_fullStr Short-Term Treatment Outcomes of Brolucizumab in Patients with Neovascular Age-Related Macular Degeneration: A Multicentre Indian Real-World Evidence Study
title_full_unstemmed Short-Term Treatment Outcomes of Brolucizumab in Patients with Neovascular Age-Related Macular Degeneration: A Multicentre Indian Real-World Evidence Study
title_short Short-Term Treatment Outcomes of Brolucizumab in Patients with Neovascular Age-Related Macular Degeneration: A Multicentre Indian Real-World Evidence Study
title_sort short-term treatment outcomes of brolucizumab in patients with neovascular age-related macular degeneration: a multicentre indian real-world evidence study
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10424695/
https://www.ncbi.nlm.nih.gov/pubmed/37583576
http://dx.doi.org/10.2147/OPTH.S415044
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