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

Korábbi kezelés

• Adverse and intolerable drug effects.
• Not complying with study medication
• Hesitation to continue with study medication

Egyéb

• Not meeting inclusion criteria.
• Inability to continue in-hospital appointments.
• Missing outcome data
• Relocation to another state or country
• Voluntary withdrawal of consent

• 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)