[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100298179":3},{"organization":4,"armGroups":7,"interventions":50,"overallOfficials":88,"centralContacts":106,"locations":116,"responsibleParty":162,"collaborators":166,"id":175,"slug":176,"hasResults":177,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":110,"eligibilityCriteria":181,"healthyVolunteers":177,"sex":182,"minAge":183,"maxAge":184,"enrollmentInfo":185,"targetDuration":110,"studyType":188,"phases":189,"briefSummary":191,"conditions":192,"keywords":195,"overallStatus":119,"whyStopped":110,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":212},{"fullName":5,"class":6},"Universidad Nacional Autonoma de Mexico","OTHER",[8,14,20,25,30,35,40,45],{"label":9,"type":10,"description":11,"interventionNames":12},"DME lactose pill","PLACEBO_COMPARATOR","Patients with DME will be randomized to take a lactose pill (placebo).",[13],"Drug: DME lactose pill",{"label":15,"type":16,"description":17,"interventionNames":18},"DME levosulpiride","EXPERIMENTAL","Patients with DME will be randomized to take levosulpiride.",[19],"Drug: DME levosulpiride",{"label":21,"type":10,"description":22,"interventionNames":23},"DR lactose pill","Patients with non-proliferative DR will be randomized to take a lactose pill (placebo)",[24],"Drug: DR lactose pill",{"label":26,"type":16,"description":27,"interventionNames":28},"DR levosulpiride","Patients with non-proliferative DR will be randomized to take levosulpiride",[29],"Drug: DR levosulpiride",{"label":31,"type":10,"description":32,"interventionNames":33},"DR, vitrectomy lactose pill","Patients with proliferative DR (undergoing medically prescribed vitrectomy 7 days after starting the study) will be randomized to take a lactose pill (placebo).",[34],"Drug: DR vitrectomy lactose pill",{"label":36,"type":16,"description":37,"interventionNames":38},"DR, vitrectomy levosulpiride","Patients with proliferative DR (undergoing medically prescribed vitrectomy 7 days after starting the study) will be randomized to take levosulpiride.",[39],"Drug: DR vitrectomy levosulpiride",{"label":41,"type":10,"description":42,"interventionNames":43},"DME plus ranibizumab lactose pill","Patients with DME that will receive intravitreal antiangiogenic therapy with ranibizumab will be randomized to take a lactose pill (placebo)",[44],"Drug: DME plus ranibizumab lactose pill",{"label":46,"type":16,"description":47,"interventionNames":48},"DME plus ranibizumab levosulpiride","Patients with DME that will receive intravitreal antiangiogenic therapy with ranibizumab will be randomized to take levosulpiride",[49],"Drug: DME plus ranibizumab levosulpiride",[51,57,62,66,70,75,80,84],{"type":52,"name":9,"description":53,"armGroupLabels":54,"otherNames":55},"DRUG","Patients with DME will take placebo orally 3 times a day (TID) for 8 weeks.The placebo is taken on top of standard therapy for diabetes and blood pressure control.",[9],[56],"placebo, sugar",{"type":52,"name":15,"description":58,"armGroupLabels":59,"otherNames":60},"Patients with DME will take levosulpiride (75 mg\u002Fday) orally TID for 8 weeks. Levosulpiride is taken on top of standard therapy for diabetes and blood pressure control.",[15],[61],"dopamine D2 receptor blocker",{"type":52,"name":21,"description":63,"armGroupLabels":64,"otherNames":65},"Patients with non-proliferative DR will take a lactose pill (placebo) orally TID for 8 weeks. The placebo is taken on top of standard therapy for diabetes and blood pressure control.",[21],[56],{"type":52,"name":26,"description":67,"armGroupLabels":68,"otherNames":69},"Patients with non-proliferative DR will take levosulpiride (75 mg\u002Fday) orally TIDfor 8 weeks. Levosulpiride is taken on top of standard therapy for diabetes and blood pressure control.",[26],[61],{"type":52,"name":71,"description":72,"armGroupLabels":73,"otherNames":74},"DR vitrectomy lactose pill","Patients with proliferative DR (undergoing medically prescribed vitrectomy 7 days after starting the study medication) will have to take a lactose pill (placebo) orally TID for one week. The last placebo pill will be taken on the morning of the day vitrectomy is performed. The placebo is taken on top of standard therapy for diabetes and blood pressure control.",[31],[56],{"type":52,"name":76,"description":77,"armGroupLabels":78,"otherNames":79},"DR vitrectomy levosulpiride","Patients with proliferative DR (undergoing medically prescribed vitrectomy 7 days after starting the study medication) will take levosulpiride (75 mg\u002Fday) orally TID for one week. The last pill will be taken on the morning of the day vitrectomy is performed. Levosulpiride is taken on top of standard therapy for diabetes and blood pressure control.",[36],[61],{"type":52,"name":41,"description":81,"armGroupLabels":82,"otherNames":83},"Patients with DME with conventional intravitreal antiangiogenic therapy with ranibizumab (0.5 mg every 4 weeks for 12 weeks) will take a lactose pill (placebo) orally TID for 24 weeks. The placebo is taken on top of standard therapy for diabetes and blood pressure control.",[41],[56],{"type":52,"name":46,"description":85,"armGroupLabels":86,"otherNames":87},"Patients with DME with receive intravitreal antiangiogenic therapy with ranibizumab (0.5 mg every 4 weeks for 12 weeks) will take a levosulpiride (75 mg\u002Fday) orally TID for 24 weeks. The study medication is taken on top of standard therapy for diabetes and blood pressure control.",[46],[61],[89,93,97,100,103],{"name":90,"affiliation":91,"role":92},"Carmen Clapp, Ph.D.","Universidad Nacional Autonoma de Mexico (UNAM)","STUDY_DIRECTOR",{"name":94,"affiliation":95,"role":96},"Ludivina Robles Osorio, M.D., Ph.D.","Universidad Autónoma de Querétaro","PRINCIPAL_INVESTIGATOR",{"name":98,"affiliation":99,"role":96},"Renata Garcia Franco, M.D.","Instituto de la Retina del Bajio SC (INDEREB)",{"name":101,"affiliation":102,"role":96},"Jakob Triebel, M.D.","Institute for Clinical Chemistry, Laboratory Medicine and Transfusion Medicine, Nuremberg General Hospital",{"name":104,"affiliation":105,"role":96},"Marlon R Garcia Roa, M.D.","Instituto Mexicano de Oftalmología (IMO)",[107,112],{"name":90,"role":108,"phone":109,"phoneExt":110,"email":111},"CONTACT","52442 2381028",null,"clapp@unam.mx",{"name":94,"role":108,"phone":113,"phoneExt":114,"email":115},"52442 1921200","5301","ludirobles7@yahoo.com",[117,146],{"facility":118,"status":119,"city":120,"state":121,"zip":122,"country":123,"countryCode":124,"cosmosGeoPoint":125,"geoPoint":130,"contacts":131},"Instituto Mexicano de Oftalmologia (IMO)","RECRUITING","Querétaro City","Querétaro","76090","Mexico","MX",{"type":126,"coordinates":127},"Point",[128,129],-100.38806,20.58806,{"lat":129,"lon":128},[132,137,140,141,144],{"name":133,"role":108,"phone":134,"phoneExt":135,"email":136},"Ellery Lopez Star, M.D.","52442 229 0776","118","ellerylopezstar@gmail.com",{"name":138,"role":108,"phone":134,"phoneExt":110,"email":139},"Marlon R García Roa, M.D.","drmgroa@hotmail.com",{"name":104,"role":96,"phone":110,"phoneExt":110,"email":110},{"name":142,"role":143,"phone":110,"phoneExt":110,"email":110},"Yolanda Villalpando Gomez, M.D.","SUB_INVESTIGATOR",{"name":145,"role":143,"phone":110,"phoneExt":110,"email":110},"Carlos D Nuñez Amaro, B.Sc.",{"facility":99,"status":119,"city":120,"state":121,"zip":147,"country":123,"countryCode":124,"cosmosGeoPoint":148,"geoPoint":150,"contacts":151},"76187",{"type":126,"coordinates":149},[128,129],{"lat":129,"lon":128},[152,155,159,160],{"name":98,"role":108,"phone":153,"phoneExt":110,"email":154},"52442 3407952","renatagarciafranco@gmail.com",{"name":156,"role":108,"phone":157,"phoneExt":110,"email":158},"Carlos D Nuñez Amaro, M.Sc.","52442 3961722","qbpcarlosamaro@gmail.com",{"name":98,"role":96,"phone":110,"phoneExt":110,"email":110},{"name":161,"role":143,"phone":110,"phoneExt":110,"email":110},"Carlos Nuñez Amaro, M.Sc.",{"type":163,"investigatorFullName":164,"investigatorTitle":165,"investigatorAffiliation":5,"oldNameTitle":110,"oldOrganization":110},"SPONSOR_INVESTIGATOR","Carmen Clapp","Principal Investigator",[167,169,170,172,173],{"name":118,"class":168},"UNKNOWN",{"name":95,"class":6},{"name":171,"class":168},"General Hospital Nuremberg & Paracelsus Medical University Nuremberg",{"name":99,"class":168},{"name":174,"class":168},"Instituto de Neurobiología, Universidad Nacional Autonoma de Mexico (UNAM)","100298179","phase-2-effect-of-levosulpiride-on-retinal-alterations-in-patients-with-diabetic-retinopathy-and-diabetic-macular-edema-100298179",false,"NCT03161652","Effect of Levosulpiride on Retinal Alterations in Patients With Diabetic Retinopathy and Diabetic Macular Edema","Clinical Trial to Evaluate the Safety and Efficacy of Levosulpiride to Improve Retinal Alterations in Patients With Diabetic Retinopathy and Diabetic Macular Edema.","Inclusion Criteria:\n\n* Age equal or greater than 40 years but no older than 69 years\n* 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.\n* Signing informed consent\n* Without ocular complications: severe myopia (\\> 6 diopters), ocular media opacity, retinal detachment, etc.\n* Without previous ocular treatments: ocular surgeries, retinal laser photocoagulation, intravitreal administration of antiangiogenic agents (delivered \\\u003C 6 months before enrollment).\n* Prolactin serum levels ≤ 20 ng\u002Fml\n* With normal or mild loss of kidney function (glomerular filtration rate \\>60 ml\u002Fmin) for groups with DME and DR without vitrectomy.\n* With mild to severe loss of kidney function (glomerular filtration rate \\>30 ml\u002Fmin) for groups with DR undergoing vitrectomy.\n* Without contraindications for the use of levosulpiride (Parkinson disease, epilepsy, breast cancer, alcoholism, hypokalemia).\n* Without hyperprolactinemia inducing conditions: Pathologies (hypothyrodism, hepatic dysfunction, prolactinomas); Medication (antipsychotics, antidepressants, prokinetics, other)\n\nExclusion Criteria:\n\n* Not meeting inclusion criteria.\n* Adverse and intolerable drug effects.\n* Not complying with study medication\n* Inability to continue in-hospital appointments.\n* Missing outcome data\n* Hesitation to continue with study medication\n* Relocation to another state or country\n* Voluntary withdrawal of consent","ALL","40 Years","69 Years",{"count":186,"type":187},120,"ESTIMATED","INTERVENTIONAL",[190],"PHASE2","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",[193,194],"Diabetic Macular Edema","Diabetic Retinopathy",[196,197,198,199,200,201,202],"diabetic retinopathy","blindness","eye","macular edema","prolactin","dopamine antagonists","peptide hormones","2025-11-17",{"date":205,"type":206},"2025-11-18","ACTUAL",{"date":208,"type":206},"2017-05-24",{"date":210,"type":187},"2027-06",{"name":164,"class":6},2]