Effect of Levosulpiride on Retinal Alterations in Patients With Diabetic Retinopathy and Diabetic Macular Edema

PHASE2RecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

May 24, 2017

Primary Completion Date

December 31, 2025

Study Completion Date

June 30, 2026

Conditions
Diabetic Macular EdemaDiabetic Retinopathy
Interventions
DRUG

DME lactose pill

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.

DRUG

DME levosulpiride

Patients with DME will take levosulpiride (75 mg/day) orally TID for 8 weeks. Levosulpiride is taken on top of standard therapy for diabetes and blood pressure control.

DRUG

DR lactose pill

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.

DRUG

DR levosulpiride

Patients with non-proliferative DR will take levosulpiride (75 mg/day) orally TIDfor 8 weeks. Levosulpiride is taken on top of standard therapy for diabetes and blood pressure control.

DRUG

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.

DRUG

DR vitrectomy levosulpiride

Patients with proliferative DR (undergoing medically prescribed vitrectomy 7 days after starting the study medication) will take levosulpiride (75 mg/day) 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.

DRUG

DME plus ranibizumab lactose pill

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.

DRUG

DME plus ranibizumab levosulpiride

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/day) orally TID for 24 weeks. The study medication is taken on top of standard therapy for diabetes and blood pressure control.

Trial Locations (2)

76090

RECRUITING

Instituto Mexicano de Oftalmologia (IMO), Querétaro

76187

RECRUITING

Instituto de la Retina del Bajio SC (INDEREB), Querétaro City

All Listed Sponsors
collaborator

Instituto Mexicano de Oftalmologia (IMO)

UNKNOWN

collaborator

Universidad Autónoma de Querétaro

OTHER

collaborator

General Hospital Nuremberg & Paracelsus Medical University Nuremberg

UNKNOWN

collaborator

Instituto de la Retina del Bajio SC (INDEREB)

UNKNOWN

collaborator

Instituto de Neurobiología, Universidad Nacional Autonoma de Mexico (UNAM)

UNKNOWN

lead

Carmen Clapp

OTHER