Effect of Levosulpiride on Retinal Alterations in Patients With Diabetic Retinopathy and Diabetic Macular Edema

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Diabetic Macular Edema, Diabetic Retinopathy

In brief

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

Key facts

Study ID

NCT03161652

Run by

Carmen Clapp

People needed

120

Starts

2017-05-24

Expected to finish

2027-06-01

Last updated by the study team

2025-11-18

Who can join

Age: 40 and older, up to 69. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• Not meeting inclusion criteria.
• Adverse and intolerable drug effects.
• Not complying with study medication
• Inability to continue in-hospital appointments.
• Missing outcome data
• Hesitation to continue with study medication
• Relocation to another state or country
• Voluntary withdrawal of consent

Where it is running

• Instituto Mexicano de Oftalmologia (IMO) — Querétaro City, Querétaro, Mexico (enrolling)
• Instituto de la Retina del Bajio SC (INDEREB) — Querétaro City, Querétaro, Mexico (enrolling)

Full record on ClinicalTrials.gov

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