Randomised, Double-blind, Comparative Clinical Study of New Ranibizumab Biosimilar in Neovascular (Wet) Age-Related Macular Degeneration

Prasad Apsangikar, Pravin Ghadge, Manoj Naik, Santosh Nair, Ravikiran Payghan Reliance Life Sciences Pvt. Ltd, Mumbai, IndiaCorrespondence: Prasad ApsangikarReliance Life Sciences Pvt. Ltd., 282 MIDC, Thane Belapur Road, Rabale, Navi Mumbai, 400701 Tel +919867610090Fax +912235338099Email prasad.apsa...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Apsangikar P, Ghadge P, Naik M, Nair S, Payghan R
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2021
Materias:	ranibizumab biosimilar amd intravitreal visual acuity Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/bfc748d57eb84b5d91fdf0803f9bcb32
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:bfc748d57eb84b5d91fdf0803f9bcb32
record_format	dspace
spelling	oai:doaj.org-article:bfc748d57eb84b5d91fdf0803f9bcb322021-12-02T18:26:44ZRandomised, Double-blind, Comparative Clinical Study of New Ranibizumab Biosimilar in Neovascular (Wet) Age-Related Macular Degeneration1177-5483https://doaj.org/article/bfc748d57eb84b5d91fdf0803f9bcb322021-07-01T00:00:00Zhttps://www.dovepress.com/randomised-double-blind-comparative-clinical-study-of-new-ranibizumab--peer-reviewed-fulltext-article-OPTHhttps://doaj.org/toc/1177-5483Prasad Apsangikar, Pravin Ghadge, Manoj Naik, Santosh Nair, Ravikiran Payghan Reliance Life Sciences Pvt. Ltd, Mumbai, IndiaCorrespondence: Prasad ApsangikarReliance Life Sciences Pvt. Ltd., 282 MIDC, Thane Belapur Road, Rabale, Navi Mumbai, 400701 Tel +919867610090Fax +912235338099Email prasad.apsangikar@relbio.comPurpose: The study was undertaken for regulatory purposes to establish clinical biosimilarity and interchangeability of a ranibizumab biosimilar with reference product.Patients and Methods: A total of 159 subjects with neovascular (wet) age-related macular degeneration (AMD) were dosed with ranibizumab. Initial double blind period of 16 weeks was followed by open-label phase till week 24. Efficacy assessment was performed at weeks 1, 4, 8, 12, 16, 20 and 24 based on best corrected visual acuity. Change in central macular thickness was assessed by optical coherence tomography from baseline to week 24. Immunogenicity assessment was done in both arms at baseline, week 16 and week 24. Safety evaluation included clinical and ophthalmic examination, adverse events, vital signs, laboratory parameters and immunogenicity in both treatment arms.Results: In the biosimilar test arm, 104 (98.11%) and 105 (99.06%) patients lost fewer than 15 letters in visual acuity at week 16 and week 24, respectively, compared with 53 (100%) at both follow-ups in reference arm. In the test arm, 27 (25.47%) and 34 (32.08%) patients gained at least 15 letters in visual acuity till week 16 and week 24 respectively, compared with 17 (32.08%) and 23 (43.30%) in the reference arm. In the test arm, mean change in central macular thickness at 24 weeks was − 89.93 μm against − 64.42 μm in the reference arm. Difference was statistically not significant for any endpoint at 16 and 24 weeks for the primary and secondary endpoints.Conclusion: The evaluation of efficacy, safety and immunogenicity was concluded to show no meaningful clinical difference for biosimilar ranibizumab with the reference product.Keywords: ranibizumab, biosimilar, AMD, intravitreal, visual acuityApsangikar PGhadge PNaik MNair SPayghan RDove Medical Pressarticleranibizumabbiosimilaramdintravitrealvisual acuityOphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 15, Pp 3087-3095 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	ranibizumab biosimilar amd intravitreal visual acuity Ophthalmology RE1-994
spellingShingle	ranibizumab biosimilar amd intravitreal visual acuity Ophthalmology RE1-994 Apsangikar P Ghadge P Naik M Nair S Payghan R Randomised, Double-blind, Comparative Clinical Study of New Ranibizumab Biosimilar in Neovascular (Wet) Age-Related Macular Degeneration
description	Prasad Apsangikar, Pravin Ghadge, Manoj Naik, Santosh Nair, Ravikiran Payghan Reliance Life Sciences Pvt. Ltd, Mumbai, IndiaCorrespondence: Prasad ApsangikarReliance Life Sciences Pvt. Ltd., 282 MIDC, Thane Belapur Road, Rabale, Navi Mumbai, 400701 Tel +919867610090Fax +912235338099Email prasad.apsangikar@relbio.comPurpose: The study was undertaken for regulatory purposes to establish clinical biosimilarity and interchangeability of a ranibizumab biosimilar with reference product.Patients and Methods: A total of 159 subjects with neovascular (wet) age-related macular degeneration (AMD) were dosed with ranibizumab. Initial double blind period of 16 weeks was followed by open-label phase till week 24. Efficacy assessment was performed at weeks 1, 4, 8, 12, 16, 20 and 24 based on best corrected visual acuity. Change in central macular thickness was assessed by optical coherence tomography from baseline to week 24. Immunogenicity assessment was done in both arms at baseline, week 16 and week 24. Safety evaluation included clinical and ophthalmic examination, adverse events, vital signs, laboratory parameters and immunogenicity in both treatment arms.Results: In the biosimilar test arm, 104 (98.11%) and 105 (99.06%) patients lost fewer than 15 letters in visual acuity at week 16 and week 24, respectively, compared with 53 (100%) at both follow-ups in reference arm. In the test arm, 27 (25.47%) and 34 (32.08%) patients gained at least 15 letters in visual acuity till week 16 and week 24 respectively, compared with 17 (32.08%) and 23 (43.30%) in the reference arm. In the test arm, mean change in central macular thickness at 24 weeks was − 89.93 μm against − 64.42 μm in the reference arm. Difference was statistically not significant for any endpoint at 16 and 24 weeks for the primary and secondary endpoints.Conclusion: The evaluation of efficacy, safety and immunogenicity was concluded to show no meaningful clinical difference for biosimilar ranibizumab with the reference product.Keywords: ranibizumab, biosimilar, AMD, intravitreal, visual acuity
format	article
author	Apsangikar P Ghadge P Naik M Nair S Payghan R
author_facet	Apsangikar P Ghadge P Naik M Nair S Payghan R
author_sort	Apsangikar P
title	Randomised, Double-blind, Comparative Clinical Study of New Ranibizumab Biosimilar in Neovascular (Wet) Age-Related Macular Degeneration
title_short	Randomised, Double-blind, Comparative Clinical Study of New Ranibizumab Biosimilar in Neovascular (Wet) Age-Related Macular Degeneration
title_full	Randomised, Double-blind, Comparative Clinical Study of New Ranibizumab Biosimilar in Neovascular (Wet) Age-Related Macular Degeneration
title_fullStr	Randomised, Double-blind, Comparative Clinical Study of New Ranibizumab Biosimilar in Neovascular (Wet) Age-Related Macular Degeneration
title_full_unstemmed	Randomised, Double-blind, Comparative Clinical Study of New Ranibizumab Biosimilar in Neovascular (Wet) Age-Related Macular Degeneration
title_sort	randomised, double-blind, comparative clinical study of new ranibizumab biosimilar in neovascular (wet) age-related macular degeneration
publisher	Dove Medical Press
publishDate	2021
url	https://doaj.org/article/bfc748d57eb84b5d91fdf0803f9bcb32
work_keys_str_mv	AT apsangikarp randomiseddoubleblindcomparativeclinicalstudyofnewranibizumabbiosimilarinneovascularwetagerelatedmaculardegeneration AT ghadgep randomiseddoubleblindcomparativeclinicalstudyofnewranibizumabbiosimilarinneovascularwetagerelatedmaculardegeneration AT naikm randomiseddoubleblindcomparativeclinicalstudyofnewranibizumabbiosimilarinneovascularwetagerelatedmaculardegeneration AT nairs randomiseddoubleblindcomparativeclinicalstudyofnewranibizumabbiosimilarinneovascularwetagerelatedmaculardegeneration AT payghanr randomiseddoubleblindcomparativeclinicalstudyofnewranibizumabbiosimilarinneovascularwetagerelatedmaculardegeneration
_version_	1718378060991954944

Randomised, Double-blind, Comparative Clinical Study of New Ranibizumab Biosimilar in Neovascular (Wet) Age-Related Macular Degeneration

Ejemplares similares