Intravitreal Stivant® (a biosimilar to bevacizumab) alone versus combined with triamcinolone in diabetic macular edema
Amin Zand1 *, Arash Daneshtalab1 , Hesam Fat'hi-zadeh1 , Meysam Shekofteh1
- Department of Ophthalmology, Shafa Hospital, Kerman University of Medical Sciences, Kerman, Iran
Abstract: To compare the effects of intravitreal Stivant® (a biosimilar to bevacizumab) alone and in combination with triamcinolone acetonide in diabetic macular edema (DME).
Methods: This was a randomized and controlled study. We assigned patients with DME to receive either intravitreal Stivant® 1.25 mg alone (IVS group) or in combination with triamcinolone acetonide 1 mg (IVST group). The regimen involved injections every 4 weeks, administered three times (at weeks 0, 4, and 8). Changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT) from baseline (week 0) to follow-ups (weeks 4, 8, and 12) were compared between the groups.
Results: Out of the 140 enrolled participants, 70 eyes of 70 patients were assigned to each group, with an average age of 59.32 ± 7.50 years. By week 12, both groups showed significant improvements in BCVA and CMT compared to baseline values (all Ps < 0.001). BCVA (in logarithm of the minimal 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 significantly differ between the two groups (P = 0.089). Similarly, although the IVST group demonstrated a significantly 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 after the next two injections. No serious adverse effects were observed in either group.
Conclusion: In eyes with 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.
