June 2023
Volume 64, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2023
Levosulpiride for the treatment of diabetic macular edema: A phase 2, randomized, pilot clinical trial
Author Affiliations & Notes
  • Mariana Edith López Hernánez
    Instituto de la Retina del Bajío, Querétaro, Mexico
  • Maria Del Carmen Clapp
    Universidad Nacional Autonoma de Mexico, Querétaro, Querétaro, Mexico
  • Carlos Nuñez
    Universidad Nacional Autonoma de Mexico, Querétaro, Querétaro, Mexico
  • Elva Adán- Castro
    Universidad Nacional Autonoma de Mexico, Querétaro, Querétaro, Mexico
  • Renata García
    Instituto de la Retina del Bajío, Querétaro, Mexico
  • Marlon García Roa
    Instituto Mexicano de Oftalmología, Querétaro, Querétaro, Mexico
  • Juan Fernando Rubio Mijangos
    Instituto Mexicano de Oftalmología, Querétaro, Querétaro, Mexico
  • Jorge Sánchez
    Instituto de la Retina del Bajío, Querétaro, Mexico
  • Gabriela Ramírez Hernández
    Universidad Nacional Autonoma de Mexico, Querétaro, Querétaro, Mexico
  • Nundehui Diaz Lezama
    Universidad Nacional Autonoma de Mexico, Querétaro, Querétaro, Mexico
  • Ellery López Star
    Instituto Mexicano de Oftalmología, Querétaro, Querétaro, Mexico
  • Thomas Bertsch
    Institute for Clinical Chemistry, Laboratory Medicine and Transfusion Medicine, Nuremberg General Hospital & Paracelsus Medical University, Nuremberg, Germany, Germany
  • Gonzálo Martínez de la Escalera
    Universidad Nacional Autonoma de Mexico, Querétaro, Querétaro, Mexico
  • Jakob Triebel
    Institute for Clinical Chemistry, Laboratory Medicine and Transfusion Medicine, Nuremberg General Hospital & Paracelsus Medical University, Nuremberg, Germany, Germany
  • Nayeli Piñeiro
    Instituto Mexicano de Oftalmología, Querétaro, Querétaro, Mexico
  • Monserrat Siqueiros
    Universidad Nacional Autonoma de Mexico, Querétaro, Querétaro, Mexico
  • Footnotes
    Commercial Relationships   Mariana López Hernánez None; Maria Clapp None; Carlos Nuñez None; Elva Adán- Castro None; Renata García None; Marlon García Roa None; Juan Fernando Rubio Mijangos None; Jorge Sánchez None; Gabriela Ramírez Hernández None; Nundehui Diaz Lezama None; Ellery López Star None; Thomas Bertsch None; Gonzálo Martínez de la Escalera None; Jakob Triebel None; Nayeli Piñeiro None; Monserrat Siqueiros None
  • Footnotes
    Support  CONACYT grants 247164 and 289568 and UNAM grant 405PC
Investigative Ophthalmology & Visual Science June 2023, Vol.64, 2657. doi:
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      Mariana Edith López Hernánez, Maria Del Carmen Clapp, Carlos Nuñez, Elva Adán- Castro, Renata García, Marlon García Roa, Juan Fernando Rubio Mijangos, Jorge Sánchez, Gabriela Ramírez Hernández, Nundehui Diaz Lezama, Ellery López Star, Thomas Bertsch, Gonzálo Martínez de la Escalera, Jakob Triebel, Nayeli Piñeiro, Monserrat Siqueiros; Levosulpiride for the treatment of diabetic macular edema: A phase 2, randomized, pilot clinical trial. Invest. Ophthalmol. Vis. Sci. 2023;64(8):2657.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : The prokinetic medication, levosulpiride, elevates vasoinhibin levels in the vitreous of patients with proliferative diabetic retinopathy (PDR) suggesting clinical benefits due to the antivasopermeability and antiangiogenic properties of vasoinhibin. We conducted a prospective, randomized, double-masked, dual-center, placebo-controlled, phase 2 pilot clinical trial to investigate the biological activity of levosulpiride in center-involving diabetic macular edema (DME).

Methods : Female and male individuals (aged 40 to 69 years) with DME involving the center of the macula and best-corrected visual acuity (BCVA) between 58 and 16 ETDRS letters at 4 m or with PDR undergoing elective pars plana vitrectomy were orally treated (TID) with levosulpiride or placebo for 8 weeks (DME patients) or for 1 week before vitrectomy (PDR patients). Changes from baseline in BCVA, central foveal thickness (CFT), and mean macular volume (MMV) were determined every 2 weeks for 8 weeks in placebo- (17 patients, 18 eyes) and levosulpiride- (17 patients, 22 eyes) treated DME groups. Vitreous levels of vascular endothelial growth factor (VEGF) and placental growth factor (PlGF) were evaluated in PDR patients after placebo (18 patients) or levosulpiride (18 patients).

Results : Levosulpiride improved changes from baseline in BCVA (P £ 0.037), CFT (P £ 0.013), and MMV (P £ 0.002) at weeks 4, 6, and 8 compared to placebo. At 8 weeks, the proportion of eyes gaining 5 letters (41% vs. 28%), loosing 21 mm 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 (BCVA) and structural parameters (CFT, MMV, OCT macula image, fundoscopy, and fluorescein angiography) 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 center 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. Supported by CONACYT grants 247164 and 289568 and UNAM grant 405PC.

This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.

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