Tests levosulpiride tablets for eye damage from diabetes
Tests levosulpiride against a placebo in adults with diabetic eye disease.
Plain-language title generated from the registry record
Registry title: Effect of Levosulpiride on Retinal Alterations in Patients With Diabetic Retinopathy and Diabetic Macular Edema
Key facts
- Where
- Querétaro City, MexicoSee the 2 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 40 to 69 with diabetic macular edema or diabetic retinopathy, without other eye problems or earlier eye treatment.
- Age
- 40 to 69 years
- Sex
- All sexes can join
- Disease stage
- Mild or moderate diabetic macular edema, non-proliferative diabetic retinopathy, or proliferative diabetic retinopathy with a vitrectomy prescribed by a doctor
- Earlier treatment
- No earlier eye surgery, retinal laser treatment, or injections of anti-angiogenic drugs into the eye within 6 months before joining
- Biomarker or test result
- Prolactin level in the blood of 20 ng/ml or lower; kidney filtration rate above 60 ml/min (above 30 ml/min for the vitrectomy group)
Main reasons for not taking part
- Severe myopia (more than 6 diopters), cloudy eye media, retinal detachment or other eye complications
- Parkinson disease, epilepsy, breast cancer, alcoholism or low potassium
- Conditions or medicines that raise prolactin, such as an underactive thyroid, liver problems, prolactinoma, antipsychotics or antidepressants
- Kidney function below the required level
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 69 years old?
Source: NCT03161652, who can take part
Where in Mexico
- Instituto de la Retina del Bajio SC (INDEREB)Querétaro City, MexicoContact: Renata Garcia Franco, M.D.Taking people
- Instituto Mexicano de Oftalmologia (IMO)Querétaro City, MexicoContact: Ellery Lopez Star, M.D.Taking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Carmen Clapp
- Trial code
- NCT03161652
- Record updated
- 18 November 2025
- Original description
This is a randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of levosulpiride to improve retinal alterations due to diabetic macular edema and diabetic retinopathyRead full original descriptionShow less
Clinical Trial to Evaluate the Safety and Efficacy of Levosulpiride to Improve Retinal Alterations in Patients With Diabetic Retinopathy and Diabetic Macular Edema.
This is a randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of levosulpiride to improve retinal alterations due to diabetic macular edema and diabetic retinopathy
Inclusion: Age equal or greater than 40 years but no older than 69 years; Male and female subjects with mild and moderate diabetic macular edema (DME), non-proliferative diabetic retinopathy (DR), and with proliferative DR undergoing medically prescribed vitrectomy; Signing informed consent; Without ocular complications: severe myopia (> 6 diopters), ocular media opacity, retinal detachment, etc; Without previous ocular treatments: ocular surgeries, retinal laser photocoagulation, intravitreal administration of antiangiogenic agents (delivered < 6 months before enrollment); Prolactin serum levels ≤ 20 ng/ml; With normal or mild loss of kidney function (glomerular filtration rate >60 ml/min) for groups with DME and DR without vitrectomy; With mild to severe loss of kidney function (glomerular filtration rate >30 ml/min) for groups with DR undergoing vitrectomy; Without contraindications for the use of levosulpiride (Parkinson disease, epilepsy, breast cancer, alcoholism, hypokalemia); Without hyperprolactinemia inducing conditions: Pathologies (hypothyrodism, hepatic dysfunction, prolactinomas); Medication (antipsychotics, antidepressants, prokinetics, other).
Exclusion: Adverse and intolerable drug effects; Not complying with study medication; Hesitation to continue with study medication; Not meeting inclusion criteria; Inability to continue in-hospital appointments; Missing outcome data; Relocation to another state or country; Voluntary withdrawal of consent.