Suprachoroidal injection of triamcinolone acetonide plus intravitreal bevacizumab in diabetic macular edema: a randomized pilot trial

Abstract

Background To investigate the efficacy of injecting suprachoroidal triamcinolone acetonide (SCTA) plus intravitreal bevacizumab (IVB) into patients with center-involving diabetic macular edema (CI-DME). Methods In this phase 2/3 randomized controlled pilot trial, sixty-six eyes with CI-DME and best-corrected visual acuity (BCVA) of at most 20/50 Snellen chart were randomly assigned into two groups. Monotherapy arm received sham injection plus 3 monthly IVB doses and combination arm received a single dose of SCTA and 3 monthly IVB doses. The mean improvements in BCVA and Central subfield thickness (CST), over the three-month was considered the main efficacy outcomes. Results The mean BCVA improvements were obtained respectively as − 0.20 ± 0.20 log [minimum angle of resolution (MAR)] (P = 0.004) and 0.37 ± 0.24 log MAR (P < 0.001) in monotherapy and combination arms [between-group analysis (P = 0.014)]. Significant improvements were also observed in CST (P = 0.019) in the combination arm compared to the other. No adverse events (elevated intraocular pressure, cataract) were observed in any of the study arms. Conclusion Significant improvements in BCVA and retinal anatomical outcomes demonstrated the additive effects of SCTA to those of anti-vascular endothelial growth factors with no short-term side effects and this combination appears to be a promising option in the management of patients with CI-DME. Trial registration The trial was registered in Iranian Registry of Clinical Trials (IRCT20200314046761N1).

Comparison between Two Doses of Suprachoroidal Triamcinolone Acetonide among Cases of Resistant Diabetic Macular Edema

“…This combination was proved to have minimal side effects and enhanced effectiveness. 22 Limitation of our research was single center study with small sample size. A 6-month follow-up might not capture long-term effects or complications that could arise over a longer duration.…”

Review of Suprachoroidal Delivery and its Application in Small Molecule Therapy

“…A recent phase II/ III trial (Iranian Registry of Clinical Trials identifier: IRCT20200314046761N1) investigated the efficacy of suprachoroidal delivery of triamcinolone acetonide (SCTA) with intravitreal delivery of bevacizumab (IVB) into eyes with centre-involving DMO (CI-DMO). 18 Results suggest that the combination of SCTA and IVB injections, rather than just intravitreal monotherapy with IVB, can provide better visual acuity improvement and greater reduction in retinal thickness and macular volume compared to IVB monotherapy in patients with CI-DMO. In addition, the combination therapy, when analysed under a mixed-model, resulted in a significantly higher resolution of macular volume compared to monotherapy.…”

A combination of suprachoroidal injection of triamcinolone using a custom-made needle and intravitreal Ziv-aflibercept every eight weeks to manage naïve/denovo central DME: a single-center retrospective case series

“…In a randomized controlled pilot trial conducted by Fazel et al, the outcomes of treating DME were compared between two groups: one receiving intravitreal bevacizumab alone and another receiving a combination of intravitreal bevacizumab with suprachoroidal injections. The study revealed additive positive effects in the combination group, with improvements observed in both BCVA and retinal anatomical outcomes [ 35 ].…”