<p>Effect of intravitreal dexamethasone solution on the reduction of macular thickness in pseudophakic diabetic patients in a public hospital in Brazil: a randomized clinical trial</p>

Abstract

Purpose To determine the effect of short-term 4 mg/mL dexamethasone solution treatment in diabetic macular edema (DME). Patients and methods Twenty-seven pseudophakic diabetic patients with visual impairment caused by DME were randomized to receive 0.01 mL (40 μg), 0.03 mL (120 μg) or 0.05 mL (200 μg) intravitreal dexamethasone solution. Eyes were evaluated in terms of macular thickness, best-corrected visual acuity (BCVA) and intraocular pressure (IOP) at 3, 7 and 28 days after injection (D). Results There was a significant reduction in macular thickness between D0 and D3 for all groups (0.01 mL – P =0.008, 0.03 mL – P =0.038, and 0.05 mL – P =0.008). Between D0 and D7, a significant reduction in macular thickness was observed in 0.01 mL and 0.05 mL groups (0.01 mL – P =0.013 and 0.05 mL – P =0.021). Between D0 and D28, no significant reduction of macular thickness was observed for any group. Between D0 and D3, a significant improvement in BCVA in the 0.03 mL group ( P =0.028) was observed. Between D0 and D7, a significant improvement in BCVA was observed in 0.01 mL and 0.03 mL groups (0.01 mL – P =0.018 and 0.03 mL – P =0.027). Between D0 and D28, a significant improvement in BCVA was observed for the 0.01 mL group ( P =0.017). No significant differences in IOP measurements were observed for any group. Safety analysis revealed no serious ocular or systemic events. Conclusion and relevance Intravitreal dexamethasone solution is effective in reducing macular thickness secondary to DME in the short-term. Improvement in short-term visual acuity was observed. Although DME requires long-term treatment, it may be a low cost therapeutic option used in specific short-term situations. Trial registration: NCT03608839 ( http://www.clinicaltrials.gov ).

Combined intravitreal dexamethasone and bevacizumab injection for the treatment of persistent diabetic macular edema (DexaBe study): a phase I clinical study

“…The baseline BCVA of our study population was 0.64 ± 0.38 and was similar to the mean baseline BCVA of the combined injection groups in the studies by Faghihi et al [ 28 ], Folgosa et al [ 29 ], and Fonseca [ 26 ]: 0.77 ± 0.33, 0.72 ± 0.38 and 0.5 ± 1.4, respectively. Similar to the 200 μg group from Fonseca’s study, our patients did not show a significant increase in mean BCVA at any study visit [ 23 ].…”

“…Despite intravitreal injections of dexamethasone phosphate were previously considered ineffective for DME probably because of rapid clearance from the vitreous and the short half-life of the drug [ 22 , 25 ], Fonseca’s [ 26 ] results showed a significant reduction in macular thickness. Their short-term follow-up study aimed to investigate the effect and safety of 4 mg/mL dexamethasone solution during 28 days follow-up, and they find a significant reduction in macular thickness 3 days after 4 mg/mL dexamethasone solution injection and a significant reduction of macular thickness was observed between D0 and D3 (p = 0.008) and D0 and D7 (p = 0.021), while no significant reduction of was seen between D0 and D28 (p = 0.859).…”

“…Their short-term follow-up study aimed to investigate the effect and safety of 4 mg/mL dexamethasone solution during 28 days follow-up, and they find a significant reduction in macular thickness 3 days after 4 mg/mL dexamethasone solution injection and a significant reduction of macular thickness was observed between D0 and D3 (p = 0.008) and D0 and D7 (p = 0.021), while no significant reduction of was seen between D0 and D28 (p = 0.859). The study showed also a significant decrease in macular thickness (12.85% over baseline values for the entire cohort) 7 days after the intravitreal injection, whereas it was speculated that the action of dexamethasone would have an effect of only a few hours, demonstrating its short-time effect in reducing macular thickness [ 26 ]. However, these authors did not investigate the combination of intravitreal dexamethasone and anti-VEGF therapy.…”

“…Elevated IOP and even “intractable” IOP are adverse events related to intravitreal or periocular steroids [ 30 , 31 ]. Fonseca et al did not observe significant IOP elevation in patients treated with a single dose of 40 μg, 120 μg, or 200 μg of intravitreal dexamethasone solution [ 26 ]. In their study with a 28-day follow-up, a maximum IOP rise of ± 1.89 mmHg occurred one day after intravitreal injection of 200 g dexamethasone aqueous solution.…”

“…In addition, our study had a longer follow-up (24 weeks versus Faghihi’s 16-week study). Fonseca’s [ 26 ] study was too short (1 month) for cataract detection and Folgosa [ 26 ] did not report cataract occurrence.…”