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New treatment option for Diabetic Macular Edema
Official title Effect of Levosulpiride on Retinal Alterations in Patients With Diabetic Retinopathy and Diabetic Macular Edema
ClinicalTrials.gov ID: NCT03161652
What this study is testing
What is DME lactose pill?
DME lactose pill is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for diabetic macular edema.
Also referred to as placebo, sugar.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 69
You may be able to join if
- Age equal or greater than 40 years but no older than 69 years
- Male and female people with mild and moderate diabetic macular edema (DME), non-proliferative diabetic retinopathy (DR), and with proliferative DR...
- 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...
You likely can't join if
- 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
See the full eligibility criteria
- Age equal or greater than 40 years but no older than 69 years
- Male and female people 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Querétaro City, Querétaro, Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 69 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Querétaro City, Querétaro, Mexico. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.