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Ranizurel safety evaluation in real-world -(RaSER) study

PURPOSE: To assess the early real-world clinical outcomes regarding safety and efficacy after ranizurel administration. METHODS: A retrospective, consecutive, interventional, uncontrolled, multi-centre study was conducted incorporating data from four centres in India. 22 eyes with variable indicatio...

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Autores principales: Sharma, Ashish, Arunaprakash, Jayshree, Das, Atheeshwar, Nayaka, Ashraya, Kumar, Nilesh, Parachuri, Nikulaa, Kuppermann, Baruch D.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8859798/
https://www.ncbi.nlm.nih.gov/pubmed/35243139
http://dx.doi.org/10.1016/j.ajoc.2022.101358
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author Sharma, Ashish
Arunaprakash, Jayshree
Das, Atheeshwar
Nayaka, Ashraya
Kumar, Nilesh
Parachuri, Nikulaa
Kuppermann, Baruch D.
author_facet Sharma, Ashish
Arunaprakash, Jayshree
Das, Atheeshwar
Nayaka, Ashraya
Kumar, Nilesh
Parachuri, Nikulaa
Kuppermann, Baruch D.
author_sort Sharma, Ashish
collection PubMed
description PURPOSE: To assess the early real-world clinical outcomes regarding safety and efficacy after ranizurel administration. METHODS: A retrospective, consecutive, interventional, uncontrolled, multi-centre study was conducted incorporating data from four centres in India. 22 eyes with variable indications were included and all patients were treated with at least one intravitreal injection of ranizurel 0.5 mg between January 2021 and April 2021. Each patient underwent best-corrected visual acuity (BCVA) measurement with a Snellen chart (converted to LogMAR for analysis), central subfield thickness (CST) analysis with spectral-domain optical coherence tomography (SD-OCT) and intraocular pressure (IOP) measurement along with complete ophthalmic examination at baseline and the last follow-up for evaluation of adverse events after ranizurel injection. RESULTS: – None of the sites reported any signs of inflammation, vasculitis or any other ocular or systemic adverse effects in any of the cases. Mean BCVA at baseline was 0.48 ± 0.26 LogMAR (20/63) which improved significantly 0.26 ± 0.28 (20/40) at the last follow-up. (p = 0.001) Mean CST at baseline was 448.4 ± 122.9 μm which improved significantly to 328.3 ± 89.9 μm. (p = 0.001). CONCLUSION: – The early real-world data from this limited series indicates that ranizurel is a safe alternative biologic for patients who were treatment-naive and in those who had undergone prior treatment with other anti-VEGF agents.
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spelling pubmed-88597982022-03-02 Ranizurel safety evaluation in real-world -(RaSER) study Sharma, Ashish Arunaprakash, Jayshree Das, Atheeshwar Nayaka, Ashraya Kumar, Nilesh Parachuri, Nikulaa Kuppermann, Baruch D. Am J Ophthalmol Case Rep Image PURPOSE: To assess the early real-world clinical outcomes regarding safety and efficacy after ranizurel administration. METHODS: A retrospective, consecutive, interventional, uncontrolled, multi-centre study was conducted incorporating data from four centres in India. 22 eyes with variable indications were included and all patients were treated with at least one intravitreal injection of ranizurel 0.5 mg between January 2021 and April 2021. Each patient underwent best-corrected visual acuity (BCVA) measurement with a Snellen chart (converted to LogMAR for analysis), central subfield thickness (CST) analysis with spectral-domain optical coherence tomography (SD-OCT) and intraocular pressure (IOP) measurement along with complete ophthalmic examination at baseline and the last follow-up for evaluation of adverse events after ranizurel injection. RESULTS: – None of the sites reported any signs of inflammation, vasculitis or any other ocular or systemic adverse effects in any of the cases. Mean BCVA at baseline was 0.48 ± 0.26 LogMAR (20/63) which improved significantly 0.26 ± 0.28 (20/40) at the last follow-up. (p = 0.001) Mean CST at baseline was 448.4 ± 122.9 μm which improved significantly to 328.3 ± 89.9 μm. (p = 0.001). CONCLUSION: – The early real-world data from this limited series indicates that ranizurel is a safe alternative biologic for patients who were treatment-naive and in those who had undergone prior treatment with other anti-VEGF agents. Elsevier 2022-02-02 /pmc/articles/PMC8859798/ /pubmed/35243139 http://dx.doi.org/10.1016/j.ajoc.2022.101358 Text en © 2022 The Authors https://creativecommons.org/licenses/by/4.0/This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Image
Sharma, Ashish
Arunaprakash, Jayshree
Das, Atheeshwar
Nayaka, Ashraya
Kumar, Nilesh
Parachuri, Nikulaa
Kuppermann, Baruch D.
Ranizurel safety evaluation in real-world -(RaSER) study
title Ranizurel safety evaluation in real-world -(RaSER) study
title_full Ranizurel safety evaluation in real-world -(RaSER) study
title_fullStr Ranizurel safety evaluation in real-world -(RaSER) study
title_full_unstemmed Ranizurel safety evaluation in real-world -(RaSER) study
title_short Ranizurel safety evaluation in real-world -(RaSER) study
title_sort ranizurel safety evaluation in real-world -(raser) study
topic Image
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8859798/
https://www.ncbi.nlm.nih.gov/pubmed/35243139
http://dx.doi.org/10.1016/j.ajoc.2022.101358
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