Intravitreal Stivant® (A Biosimilar to Bevacizumab) Alone Versus Combined With Triamcinolone in Center-Involved Diabetic Macular Edema Publisher



Daneshtalab A¹ ; Shekofteh M¹ ; Fathizadeh H¹ ; Rajabi MT² ; Rafizadeh SM² ; Aghajani A² ; Esfandiarifard S² ; Akbari Z³ ; Sardarinia M⁴ ; Jamalipour Soufi K⁴ ; Zand A^{1, 2} Show Affiliations
Source: JFO Open Ophthalmology Published:2025

Abstract

Purpose: To compare the effects of intravitreal Stivant® (a biosimilar to bevacizumab) alone and in combination with triamcinolone acetonide in center-involved diabetic macular edema (DME). Methods: In this randomized controlled study, patients with center-involved DME (central macular thickness [CMT] > 300 μm) were assigned to receive either intravitreal Stivant® 1.25 mg alone (IVS group) or in combination with triamcinolone acetonide 1 mg (IVST group). The regimen consisted of injections every 4 weeks, administered three times. Changes in best-corrected visual acuity (BCVA) and CMT from baseline to follow-up visits were compared between the groups. Results: Of the 140 enrolled participants, 70 eyes of 70 patients were assigned to each group. By week 12, both groups showed improvements in BCVA and CMT compared to baseline values (Ps < 0.001). BCVA (in logarithm of the minimum angle of resolution [logMAR] scale) improved more in the IVST group (0.75 ± 0.62 logMAR) compared to the IVS group (0.92 ± 0.93 logMAR, P < 0.001) at week 4. However, by week 12, BCVA did not differ between the two groups (P = 0.089). Similarly, although the IVST group demonstrated a higher reduction in mean CMT (−143.40 ± 58.28 μm) compared to the IVS group (−92.19 ± 52.31 μm, P < 0.001) at week 4, this effect did not persist at the next follow-up visits. Conclusion: In eyes with center-involved DME, IVST is more effective in reducing CMT and improving BCVA than IVS up to 1 month, but this superiority does not persist over time. © 2025 The Author(s)