Levosulpiride for the treatment of diabetic macular oedema: a phase 2 randomized clinical trial.

Carlos D Núñez-Amaro, Mariana López, Elva Adán-Castro, Ma Ludivina Robles-Osorio, Renata García-Franco, Marlon García-Roa, Yolanda Villalpando-Gómez, Paulina Ramírez-Neria, Nayeli Pineiro, Juan Fernando Rubio-Mijangos, Jorge Sánchez, Gabriela Ramírez-Hernández, Lourdes Siqueiros-Márquez, Nundehui Díaz-Lezama, Ellery López-Star, Thomas Bertsch (Co-author), Gonzalo Marínez de la Escalera, Jakob Triebel (Co-author), Carmen Clapp

Research output: Contribution to journalOriginal Articlepeer-review

1 Citation (Web of Science)

Abstract

BACKGROUND/OBJECTIVE: The prokinetic levosulpiride elevates vasoinhibin levels in the vitreous of patients with proliferative
diabetic retinopathy (PDR) suggesting clinical benefits due to the anti-vasopermeability and anti-angiogenic properties of
vasoinhibin. We investigated the biological activity of levosulpiride in centre-involving diabetic macular oedema (DME).
PATIENTS/METHODS: Prospective, randomized, double-blinded, dual-centre, phase 2 trial in patients with centre-involving DME
orally treated with placebo (n = 17) or levosulpiride (n = 17) for 8 weeks or in patients with PDR undergoing elective pars plana
vitrectomy and receiving placebo (n = 18) or levosulpiride (n = 18) orally for the 1 week before vitrectomy.
RESULTS: Levosulpiride improved changes from baseline in best-corrected visual acuity (p ≤ 0.037), central foveal thickness (CFT,
p ≤ 0.013), and mean macular volume (MMV, p ≤ 0.002) at weeks 4, 6, and 8 compared to placebo. At 8 weeks, the proportion of
eyes gaining ≥5 ETDRS letters at 4 m (41% vs. 28%), losing ≥21 μm in CFT (55% vs. 28%), and dropping ≥0.06 mm3 in MMV (65% vs.
29%) was higher after levosulpiride than placebo. The overall grading of visual and structural parameters improved with
levosulpiride (p = 0.029). Levosulpiride reduced VEGF (p = 0.025) and PlGF (p = 0.008) levels in the vitreous of PDR patients. No
significant adverse side-effects were detected.
CONCLUSIONS: Oral levosulpiride for 8 weeks improved visual and structural outcomes in patients with centre-involving DME by
mechanisms that may include intraocular upregulation of vasoinhibin and downregulation of VEGF and PlGF. Larger clinical trials
evaluating long-term efficacy and safety are warranted.
Original languageEnglish
JournalEYE
Early online date2023
DOIs
Publication statusPublished - 2023

Keywords

  • ENDOTHELIAL GROWTH-FACTOR
  • RETINOPATHY
  • PROLACTIN
  • VASOINHIBIN
  • VEGF
  • BEVACIZUMAB
  • ANGIOGENESIS
  • RANIBIZUMAB
  • AFLIBERCEPT
  • EYES

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