NCT03161652RecruitingPhase 2
Effect of Levosulpiride on Retinal Alterations in Patients With Diabetic Retinopathy and Diabetic Macular Edema
Clinical Trial to Evaluate the Safety and Efficacy of Levosulpiride to Improve Retinal Alterations in Patients With Diabetic Retinopathy and Diabetic Macular Edema.
Source: ClinicalTrials.gov · Last updated 18 Nov 2025
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 18 May 2017
- Start date
- 24 May 2017
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Carmen Clapp
- Diseases
- Diabetic eye disease
- NCT number
- NCT03161652
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 120
- From 24 May 2017 to the primary completion date, 31 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Adverse and intolerable drug effects.
- Not complying with study medication
- Hesitation to continue with study medication
Other
- Not meeting inclusion criteria.
- Inability to continue in-hospital appointments.
- Missing outcome data
- Relocation to another state or country
- Voluntary withdrawal of consent
Who the study is looking for
- 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)
Age in the registry: 40 years to 69 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto Mexicano de Oftalmologia (IMO) Coordinator of this site? Confirm its status | Querétaro City | Mexico | Recruiting |
| Instituto de la Retina del Bajio SC (INDEREB) Coordinator of this site? Confirm its status | Querétaro City | Mexico | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.