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

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Carmen Clapp
• Collaborators: General Hospital Nuremberg & Paracelsus Medical University Nuremberg; Instituto de la Retina del Bajio SC (INDEREB); Instituto de Neurobiología, Universidad Nacional Autonoma de Mexico (UNAM); Instituto Mexicano de Oftalmologia; Instituto Mexicano de Oftalmologia (IMO); Universidad Autónoma de Querétaro
• Treatments: Angiogenesis Inhibitors; Dopamine; Dopamine Agents; Ranibizumab; Sulpiride

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