Year: 2025
Type: article
Abstract: Background: Diabetic macular edema (DME) is a leading cause of vision impairment globally among working population, with anti-vascular endothelial growth factor (anti-VEGF) therapies being the standard treatment. The high cost of anti-VEGF drive use of biosimilars like Razumab®. This study provides a prospective real-world comparison of innovator ranibizumab and Razumab® in treatment-naïve DME patients, addressing the current gap in comparative data. Methods: A prospective observational study was conducted involving 60 treatment-naïve DME patients, equally divided into two groups: Ranibizumab and Razumab®. Each group received three intravitreal injections at monthly intervals. Best corrected visual acuity (BCVA) and central subfoveal thickness (CSFT) were measured at baseline and at 4, 8, and 12 weeks. Results: Both groups demonstrated significant improvements in BCVA and CSFT from baseline to 12 weeks. The Ranibizumab group showed a reduction in CSFT from 447.43 ± 61.87 µm to 314.00 ± 24.74 µm, and the Razumab® group from 449.47 ± 47.12 µm to 330.13 ± 27.17 µm (p >0.05). BCVA improved from 0.77 ± 0.10 to 0.32 ± 0.06 logMAR in the Ranibizumab group and from 0.78 ± 0.10 to 0.34 ± 0.06 logMAR in the Razumab® group (p >0.05). Conclusion: The study confirms that Razumab® is non-inferior to Ranibizumab in terms of efficacy and safety for managing DME. Its cost-effectiveness makes it a suitable alternative, particularly in resource-limited settings without compromising safety or efficacy.
Authors: Dhandapani A, Ravindran S, Muthusamy K, Muruganandham K, Kaliamurty S
Language: English
Subfield: Ophthalmology
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W4412067455