A Prospective Interventional Study to Find the Effectivity of Razumab by Measuring Macular Oedema before and after Intravitreal Injection

Aim: To test effectiveness (before and after) of a single dose of intravitreal Razumab in treatment naïve patients with macular oedema due to diabetic retinopathy or retinal vein occlusion. Introduction: Razumab® is the world’s first biosimilar to Ranibizumab approved in India by DCGI in 2015. We ai...

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Main Authors: V.K Malathi, Radhika Dinesh, A Rajeswari
Format: Article
Language:English
Published: Wolters Kluwer Medknow Publications 2025-01-01
Series:TNOA Journal of Ophthalmic Science and Research
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Online Access:https://journals.lww.com/10.4103/tjosr.tjosr_148_24
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author V.K Malathi
Radhika Dinesh
A Rajeswari
author_facet V.K Malathi
Radhika Dinesh
A Rajeswari
author_sort V.K Malathi
collection DOAJ
description Aim: To test effectiveness (before and after) of a single dose of intravitreal Razumab in treatment naïve patients with macular oedema due to diabetic retinopathy or retinal vein occlusion. Introduction: Razumab® is the world’s first biosimilar to Ranibizumab approved in India by DCGI in 2015. We aim to study the efficacy of Razumab, in reducing macular oedema due to diabetic retinopathy (DR) and retinal vein occlusion based on optical coherence tomography (Non invasive imaging) in a medical college hospital over 1 year. Materials and Methods: A prospective interventional (before and after) study conducted on treatment naïve patients diagnosed with macular oedema secondary to DR or retinal vein occlusion with best-corrected visual acuity (BCVA) according to LogMAR chart ≤0.2 and central retinal thickness (CRT) by OCT ≥315 μ. Inj Razumab 0.5 mg in 0.05 ml was given intravitreally. The patient was followed up after 1 week and 4 weeks. The BCVA and OCT were repeated 1 month postoperatively. Results: 68% of patients showed clinical improvement at the end of 1 month follow-up. Paired samples test showed a statistically significant P value of 0.0001 for pre- and postinjection BCVA at the end of 1 month. A statistically significant P value of 0.0001 was obtained for pre- and postinjection CRT at the end of 1 month. Conclusion: This study demonstrates the short-term efficacy of action of a single dose of Razumab and is predictive of its success as an effective treatment option for retinal vascular diseases in developing countries.
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spelling doaj-art-1bd21e2b4f3246e0a1c92736faf830fc2025-08-20T02:16:55ZengWolters Kluwer Medknow PublicationsTNOA Journal of Ophthalmic Science and Research2589-45282589-45362025-01-01631616510.4103/tjosr.tjosr_148_24A Prospective Interventional Study to Find the Effectivity of Razumab by Measuring Macular Oedema before and after Intravitreal InjectionV.K MalathiRadhika DineshA RajeswariAim: To test effectiveness (before and after) of a single dose of intravitreal Razumab in treatment naïve patients with macular oedema due to diabetic retinopathy or retinal vein occlusion. Introduction: Razumab® is the world’s first biosimilar to Ranibizumab approved in India by DCGI in 2015. We aim to study the efficacy of Razumab, in reducing macular oedema due to diabetic retinopathy (DR) and retinal vein occlusion based on optical coherence tomography (Non invasive imaging) in a medical college hospital over 1 year. Materials and Methods: A prospective interventional (before and after) study conducted on treatment naïve patients diagnosed with macular oedema secondary to DR or retinal vein occlusion with best-corrected visual acuity (BCVA) according to LogMAR chart ≤0.2 and central retinal thickness (CRT) by OCT ≥315 μ. Inj Razumab 0.5 mg in 0.05 ml was given intravitreally. The patient was followed up after 1 week and 4 weeks. The BCVA and OCT were repeated 1 month postoperatively. Results: 68% of patients showed clinical improvement at the end of 1 month follow-up. Paired samples test showed a statistically significant P value of 0.0001 for pre- and postinjection BCVA at the end of 1 month. A statistically significant P value of 0.0001 was obtained for pre- and postinjection CRT at the end of 1 month. Conclusion: This study demonstrates the short-term efficacy of action of a single dose of Razumab and is predictive of its success as an effective treatment option for retinal vascular diseases in developing countries.https://journals.lww.com/10.4103/tjosr.tjosr_148_24anti-vascular endothelial growth factorbiosimilarmacular oedemarazumab
spellingShingle V.K Malathi
Radhika Dinesh
A Rajeswari
A Prospective Interventional Study to Find the Effectivity of Razumab by Measuring Macular Oedema before and after Intravitreal Injection
TNOA Journal of Ophthalmic Science and Research
anti-vascular endothelial growth factor
biosimilar
macular oedema
razumab
title A Prospective Interventional Study to Find the Effectivity of Razumab by Measuring Macular Oedema before and after Intravitreal Injection
title_full A Prospective Interventional Study to Find the Effectivity of Razumab by Measuring Macular Oedema before and after Intravitreal Injection
title_fullStr A Prospective Interventional Study to Find the Effectivity of Razumab by Measuring Macular Oedema before and after Intravitreal Injection
title_full_unstemmed A Prospective Interventional Study to Find the Effectivity of Razumab by Measuring Macular Oedema before and after Intravitreal Injection
title_short A Prospective Interventional Study to Find the Effectivity of Razumab by Measuring Macular Oedema before and after Intravitreal Injection
title_sort prospective interventional study to find the effectivity of razumab by measuring macular oedema before and after intravitreal injection
topic anti-vascular endothelial growth factor
biosimilar
macular oedema
razumab
url https://journals.lww.com/10.4103/tjosr.tjosr_148_24
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