Abstract

AbstractPurpose: To investigate if the oral administration of sodium‐glucose cotransporter 2 (SGLT2) inhibitors may have a relevant role modifying the diabetic macular edema (DME) in naïve eyes of diabetic patients.Methods: We conducted a single‐arm pilot study including 6 eyes from 4 patients with type 2 DM with de novo DME who had never been treated with intravitreal injections of VEGF. We performed a first visit to ensure adequate metabolic control and blood pressure of the patients. Later, we add 100 mg/day of oral canagliflozin with an increase of 300 mg of canagliflozin at second month. In this study, visual acuity (VA) and central retinal thickness (CRT, μm) prior to and at 3 months after the initiation of SGLT2 inhibitors were retrospectively compared.Results: 3 of 4 patients maintained or improved their visual acuity. Only one patient worsened their visual accuracy in both eyes at week 12, and since this case exceeded the preset limit of 5 letters, the progression of DME was considered, requiring rescue with intravitreal anti‐VEGF treatment, according to the pre‐established protocol. After 12 weeks of follow‐up, median CRT improved from 317.5 to 302 μm (mean 15.5 μm).Maximum ILM‐EPR height of edema also reduced from 482 to 438 μm (mean 42.1 μm) None of the four patients reported severe adverse effects.Conclusions: To our knowledge, this pilot study is the first to evaluate the effect of oral canagliflozin in a series of patients with DME who have not previously received intraocular therapy or undergone vitreoretinal surgery. Based on our preliminary results, we could speculate that SGLT2i inhibitors may be useful to decrease DME within 12 weeks of treatment, with improvement of visual accuracy avoiding invasive treatments. Larger clinical studies are needed to confirm this relationship.

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