Levosulpiride treatment for diabetic eye conditions
Clinical Trial to Evaluate the Safety and Efficacy of Levosulpiride to Improve Retinal Alterations in Patients With Diabetic Retinopathy and Diabetic Macular Edema.
This study is testing if a medication called levosulpiride can help improve eye problems caused by diabetes in people aged 40 to 69.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 40 Years to 69 Years |
| Sex | All |
| Sponsor | Universidad Nacional Autonoma de Mexico Academic / other |
| Locations | 2 sites (Querétaro City, Querétaro and 1 other locations) |
| Trial ID | NCT03161652 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40 to 69 with mild to moderate diabetic macular edema or non-proliferative diabetic retinopathy who meet specific health criteria.
Not a fit: Patients with severe ocular complications, recent ocular treatments, or contraindications for levosulpiride will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from diabetic retinopathy and diabetic macular edema, potentially improving their vision and quality of life.
How similar studies have performed: While the approach of using levosulpiride is novel, preclinical studies suggest a protective role for prolactin, indicating potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Querétaro City, Querétaro and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.