Effect of Levosulpiride on Retinal Alterations in Patients With Diabetic Retinopathy and Diabetic Macular Edema
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-69
SponsorCarmen Clapp
About this trial
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
Not meeting inclusion criteria.
Adverse and intolerable drug effects.
Not complying with study medication
Inability to continue in-hospital appointments.
Trial design
Treatments tested in this trial
- 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
Treatment groups
120 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Carmen Clapp
Lead sponsor
Universidad Nacional Autonoma de Mexico
Sponsor institution
Instituto Mexicano de Oftalmologia (IMO)
Collaborator
Universidad Autónoma de Querétaro
Collaborator
General Hospital Nuremberg & Paracelsus Medical University Nuremberg
Collaborator
Instituto de la Retina del Bajio SC (INDEREB)
Collaborator
Instituto de Neurobiología, Universidad Nacional Autonoma de Mexico (UNAM)
Collaborator
Source ClinicalTrials.gov