Discussion
vascular retinopathies, centre-involving, diabetic, hyperprolactinemia, ocular complications, vision loss, gain of vision
HYPERPROLACTINEMIA, MACULAR OEDEMA, DIABETIC GASTROPARESIS, COMPLICATION
Levosulpiride is a prokinetic [The study was designed to assess the efficacy of levosulpiride in previously untreated DME patients with the caveat of deferring for the end of the study any other treatment. Accordingly, the protocol was short-termed (8 weeks) and carried out in DME patients with moderate vision loss (defined as ≥16 ETDRS letters at 4 m; Snellen equivalent ~20/100) that were carefully evaluated every 2 weeks. Levosulpiride showed meaningful responses compared with the natural history of the process (demonstrated by the placebo group). Mean changes in visual and anatomical parameters improved early (4 weeks) after initiating levosulpiride treatment. At week 8, gain and losses from baseline in BCVA (+6 letters), CFT (−46.6 μm), and MMV (−0.49 mmLevosulpiride efficacy rate in gain of vision (41%) was lower than efficacy rates in CFT (55%) and MMV (65%). Improvements in anatomical parameters are indicative of resolution of macular oedema and may [Beneficial outcomes are outstanding when considering that levosulpiride is a non-invasive orally active medication that contrasts with the standard care of DME using intravitreal drug delivery, which poses a risk of ocular complications [As expected, levosulpiride did not pose any significant safety concern during the 8 weeks of treatment. We used the oral dose of levosulpiride (25 mg TID) employed for the treatment of diabetic gastroparesis, a complication found in 5% of diabetic patients [This study had several strengths including a powerful assessment of adherence to treatment monitored by the high efficacy of levosulpiride-induced hyperprolactinemia [In summary, this interventional, randomized, placebo-controlled phase 2 study, in which levosulpiride was administered orally according to indications of use in daily practice, showed the effectiveness and safety of this prokinetic agent for improving visual and structural outcomes in patients with centre-involving DME. Its mechanism of action may involve the PRL/vasoinhibin axis [Our study repositions levosulpiride outside its prokinetic scope as a safe, affordable, and early treatment for DME, DR, and other vascular retinopathies. Larger and longer studies are needed to solidify these findings.