Protocol
hyperprolactinemia, Diabetic Retinopathy, glaucoma, centre-involving
DIABETIC RETINOPATHY, BLIND, GLAUCOMA, HYPERPROLACTINEMIA, TYPE 2 DIABETES, INTRAOCULAR PRESSURE
From 176 screened mestizo patients with type 2 diabetes, there were 55 eligible centre-involving DME participants (aged 40–69 years, best-corrected visual acuity (BCVA) between 58 to 16 Early Treatment Diabetic Retinopathy Study (ETDRS) letters at 4 m (20/16 to 20/100 Snellen equivalent), and central foveal thickness (CFT) of ≥224 μm). After participants provided their written informed consent, blood samples were withdrawn to evaluate basal PRL levels and safety parameters [thyroid stimulating hormone (TSH), glycated haemoglobin (HbA1c), and creatinine]. Twelve patients were excluded [4 due to hyperprolactinemia (>20 ng/ml), 3 because of glomerular filtration rates <28 ml/min, 4 due to hard exudates in the fovea region, and 1 for receiving glaucoma treatment]. The remaining 43 subjects were randomized by the study coordinator based on a computer-generated list of random numbers in a 1:1 allocation ratio to receive levosulpiride (DISLEP®, Ferrer Therapeutics; 25-mg orally TID) or placebo (lactose pill orally TID) during a follow-up period of 8 weeks and study visits every 2 weeks. From the 43 subjects, 9 dropped out [5 did not comply with levosulpiride treatment confirmed by the circulating levels of PRL, 2 were hesitant to continue with study medication (one placebo and one levosulpiride), and 2 were unable to maintain visit appointments]. Thirty-four study subjects (12 females and 22 males) completed the study (17 treated with placebo and 17 with levosulpiride) and were evaluated [medical history, physical examination, BCVA, optical coherence tomography (OCT), blood and intraocular pressure, fundoscopy, and laboratory analysis of blood samples] at baseline and at study visits every 2 weeks. Determination of TSH was only done at baseline and HbA1c and fluorescein angiography were done at baseline and at week 8. Patients and investigators assessing outcomes were blind to treatment assignment.