Evidence map›Paper›PMID 37673971›Full record

Trial reportEye (London, England)2024

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 and 9 more

Open access · hybridAbstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in Eye (London, England), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.7field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 6 citations in OpenAlex.

  1. Review
  2. Therapeutic potential of prolactin-releasing anti-dopaminergic agents in experimental diabetic retinopathy model.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2026
    Article
  3. Article
  4. Article
  5. Diabetic macular edema: Upcoming therapies.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2025
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 4 institutions in 2 countries.

Carlos D Núñez-Amaro *Facultad de Ciencias Naturales, Universidad Autónoma de Querétaro (UAQ), Querétaro, México.
Mariana López *Instituto Mexicano de Oftalmología (IMO), Querétaro, México.
Elva Adán-Castro *Instituto de Neurobiología, Universidad Nacional Autónoma de México (UNAM), Campus UNAM-Juriquilla, Querétaro, México.
Ma Ludivina Robles-OsorioFacultad de Ciencias Naturales, Universidad Autónoma de Querétaro (UAQ), Querétaro, México.
Renata García-FrancoInstituto de la Retina del Bajío (INDEREB), Querétaro, México.
Marlon García-RoaInstituto Mexicano de Oftalmología (IMO), Querétaro, México.
Yolanda Villalpando-GómezInstituto Mexicano de Oftalmología (IMO), Querétaro, México.
Paulina Ramírez-NeriaInstituto Mexicano de Oftalmología (IMO), Querétaro, México.
Nayeli PineiroInstituto Mexicano de Oftalmología (IMO), Querétaro, México.
Juan Fernando Rubio-MijangosInstituto Mexicano de Oftalmología (IMO), Querétaro, México.ORCID 0000-0003-3853-1934
Jorge SánchezInstituto de la Retina del Bajío (INDEREB), Querétaro, México.
Gabriela Ramírez-HernándezInstituto de Neurobiología, Universidad Nacional Autónoma de México (UNAM), Campus UNAM-Juriquilla, Querétaro, México.
Lourdes Siqueiros-MárquezInstituto de Neurobiología, Universidad Nacional Autónoma de México (UNAM), Campus UNAM-Juriquilla, Querétaro, México.
Nundehui Díaz-LezamaInstituto de Neurobiología, Universidad Nacional Autónoma de México (UNAM), Campus UNAM-Juriquilla, Querétaro, México.
Ellery López-StarInstituto Mexicano de Oftalmología (IMO), Querétaro, México.
Thomas BertschInstitute for Clinical Chemistry, Laboratory Medicine and Transfusion Medicine, Nuremberg General Hospital and Paracelsus Medical University, Nuremberg, Germany.
Gonzalo Marínez de la EscaleraInstituto de Neurobiología, Universidad Nacional Autónoma de México (UNAM), Campus UNAM-Juriquilla, Querétaro, México.
Jakob TriebelInstitute for Clinical Chemistry, Laboratory Medicine and Transfusion Medicine, Nuremberg General Hospital and Paracelsus Medical University, Nuremberg, Germany.ORCID 0000-0002-1989-8645
Carmen ClappInstituto de Neurobiología, Universidad Nacional Autónoma de México (UNAM), Campus UNAM-Juriquilla, Querétaro, México. clapp@unam.mx.ORCID 0000-0002-7670-6718
Instituto Mexicano de Oftalmología IAP · MXUniversidad Nacional Autónoma de México · MXAutonomous University of Queretaro · MXNuremberg Hospital · DE

Funding

Consejo Nacional de Ciencia y Tecnología (National Council of Science and Technology, Mexico) 247164,289568, A1-S-9620BConsejo Nacional de Ciencia y Tecnología (National Council of Science and Technology, Mexico) 247164, 289568, and A1-S-9620BUniversidad Nacional Autónoma de México (National Autonomous University of Mexico) 405PC
6 · The paper itself

Abstract

BACKGROUND/

objectiveThe 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/

methodsProspective, 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.

resultsLevosulpiride 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 mm

conclusionsOral 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.

Indexed as

Diabetes MellitusDiabetic RetinopathyMacular EdemaAngiogenesis InhibitorsAntibodies, Monoclonal, HumanizedHumansIntravitreal InjectionsProspective StudiesSulpirideVascular Endothelial Growth Factor AAngiogenesis InhibitorsAntibodies, Monoclonal, HumanizedlevosulpirideSulpirideVascular Endothelial Growth Factor A

Identifiers

PMID37673971
PMCPMC10858020
OpenAlexW4386483221

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.