Levosulpiride treatment for diabetic eye conditions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of levosulpiride, a dopamine D2 receptor blocker, in improving retinal alterations caused by diabetic macular edema (DME) and diabetic retinopathy (DR). It is a randomized, double-blind, placebo-controlled study involving patients aged 40 to 69 with mild to moderate DME and non-proliferative DR. The trial aims to assess the impact of levosulpiride on retinal health by measuring ophthalmologic and health parameters before and after treatment. The study also considers the role of prolactin levels in the treatment of these conditions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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's running

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

Study contacts

• Principal investigator: Ludivina Robles Osorio, M.D., Ph.D. — Universidad Autónoma de Querétaro
• Study coordinator: Carmen Clapp, Ph.D.
• Email: clapp@unam.mx
• Phone: 52442 2381028

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Testing THN391 for Diabetic Macular Edema

  This study is testing a new drug called THN391 to see if it can safely help people with diabetic macular edema caused by diabetes.

  Recruiting at 8 sites Phase 1 Therini Bio, Inc. · Parramatta, New South Wales and 9 other locations · NCT06701721

• Comparing single-session and multiple-session laser treatment for diabetic eye disease

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• Treatment for diabetic retinopathy with MS-553

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  Recruiting at 3 sites Phase 1 MingSight Pharmaceuticals, Inc · Changsha, Hunan and 2 other locations · NCT04187443

• Corticosteroid for Diabetic Macular Edema (DME) in Adults with Diabetic Retinopathy

  This trial tests whether intravitreal corticosteroid injections can influence inflammatory biomarkers and improve DME in adults with type 2 diabetes.

  Recruiting Phase 4 Vanderbilt University Medical Center · Nashville, Tennessee · NCT07843849

• Blepharoptosis After Repeated Anti-VEGF Injections in One Eye

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• Automated detection of diabetic retinopathy lesions in fundus photos

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  Recruiting Democritus University of Thrace · Alexandroupoli · NCT07758582

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.