Actively Recruiting
Effect of Levosulpiride on Retinal Alterations in Patients With Diabetic Retinopathy and Diabetic Macular Edema
Led by Carmen Clapp · Updated on 2025-11-18
120
Participants Needed
2
Research Sites
522 weeks
Total Duration
On this page
Sponsors
C
Carmen Clapp
Lead Sponsor
I
Instituto Mexicano de Oftalmologia (IMO)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Effect of Levosulpiride on Retinal Alterations in Patients With Diabetic Retinopathy and Diabetic Macular Edema
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 such as severe myopia (> 6 diopters), ocular media opacity, retinal detachment
- Without previous ocular treatments including ocular surgeries, retinal laser photocoagulation, or intravitreal antiangiogenic agents delivered less than 6 months before enrollment
- Prolactin serum levels less than or equal to 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 such as Parkinson disease, epilepsy, breast cancer, alcoholism, hypokalemia
- Without hyperprolactinemia inducing conditions including hypothyroidism, hepatic dysfunction, prolactinomas, or use of medications like antipsychotics, antidepressants, prokinetics
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Instituto Mexicano de Oftalmologia (IMO)
Querétaro City, Querétaro, Mexico, 76090
Actively Recruiting
2
Instituto de la Retina del Bajio SC (INDEREB)
Querétaro City, Querétaro, Mexico, 76187
Actively Recruiting
Research Team
C
Carmen Clapp, Ph.D.
CONTACT
L
Ludivina Robles Osorio, M.D., Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
8
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