Effect of Levosulpiride on Retinal Alterations in Patients With Diabetic Retinopathy and Diabetic Macular Edema
Diabetic Macular Edema, Diabetic Retinopathy
About this trial
This is an interventional treatment trial for Diabetic Macular Edema focused on measuring diabetic retinopathy, blindness, eye, macular edema, prolactin, dopamine antagonists, peptide hormones
Eligibility 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
Sites / Locations
- Instituto de la Retina del Bajio SC (INDEREB)Recruiting
- Instituto Mexicano de Oftalmologia (IMO)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
DME lactose pill
DME levosulpiride
DR lactose pill
DR levosulpiride
DR, vitrectomy lactose pill
DR, vitrectomy levosulpiride
DME plus ranibizumab lactose pill
DME plus ranibizumab levosulpiride
Patients with DME will be randomized to take a lactose pill (placebo).
Patients with DME will be randomized to take levosulpiride.
Patients with non-proliferative DR will be randomized to take a lactose pill (placebo)
Patients with non-proliferative DR will be randomized to take levosulpiride
Patients with proliferative DR (undergoing medically prescribed vitrectomy 7 days after starting the study) will be randomized to take a lactose pill (placebo).
Patients with proliferative DR (undergoing medically prescribed vitrectomy 7 days after starting the study) will be randomized to take levosulpiride.
Patients with DME that will receive intravitreal antiangiogenic therapy with ranibizumab will be randomized to take a lactose pill (placebo)
Patients with DME that will receive intravitreal antiangiogenic therapy with ranibizumab will be randomized to take levosulpiride