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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 A1, 2
Authors
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Authors Affiliations
  1. 1. Clinical Research Development Unit, Shafa Hospital, Kerman University of Medical Sciences, Kerman, Iran
  2. 2. Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran
  3. 3. Faculty of Medicine, Kerman University of Medical Sciences, Kerman, Iran
  4. 4. Eye Research Center, Eye Department, The Five Senses Health Institute, Rassoul Akram Hospital, School of Medicine, Iran University of Medical Sciences, Tehran, Iran

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)