Efficacy and Safety of Biosimilar Ranibizumab Age-Related Macular Degeneration: A Double-Blind, Randomized, Multicenter, Phase III Study

Objective: This study aimed to compare efficacy, safety, and immunogenicity of the biosimilar ranibizumab in comparison with the Innovator Ranibizumab in treatment-naive patients with neovascular (wet) age-related macular degeneration (nAMD or wAMD). Materials and Methods: This comparative, double b...

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Bibliographic Details
Published in:Clinical ophthalmology (Auckland, N.Z.) N.Z.), 2024-11, Vol.18, p.3071
Main Authors: Rana, Parth J, Deshmukh, Himanshu, Shah, Urmil, Kumar, Vinod, Kanungo, Sanghamitra, Singhal, Deepika, Mahapatra, Santosh Kumar, Vakharia, Ira, Jaiswal, Mukesh, Gondane, Ajitkumar, Vaidya, Pooja, Shahavi, Vinayaka, Shandilya, Harish, Pawar, Dattatray, Sharma, Akhilesh
Format: Article
Language:English
Subjects:
Antibodies
Clinical trials
Comparative analysis
Macular degeneration
Medical research
Medicine, Experimental
Ophthalmic drugs
Physiological aspects
Verteporfin
Viral antibodies
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Summary:Objective: This study aimed to compare efficacy, safety, and immunogenicity of the biosimilar ranibizumab in comparison with the Innovator Ranibizumab in treatment-naive patients with neovascular (wet) age-related macular degeneration (nAMD or wAMD). Materials and Methods: This comparative, double blind, multicentre, Phase III clinical study randomized eligible patients in a 3:1 ratio to receive either OPTIMAB[R] (Alkem Laboratories Ltd./ Enzene Biosciences Ltd.) or Innovator Ranibizumab. Intravitreal injections of Innovator Ranibizumab (0.5 mg in 0.05 mL) and OPTIMAB[R] (0.5 mg in 0.05 mL) were administered every four weeks for 12 weeks (three doses). Primary efficacy endpoints included loss of
ISSN:1177-5483
DOI:10.2147/OPTH.S488866