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

Summary

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

• Diabetic Macular Edema
• Diabetic 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.

Sponsors & Collaborators

• Instituto Mexicano de Oftalmologia (IMO)

  collaborator UNKNOWN

• Universidad Autónoma de Querétaro

  collaborator OTHER

• General Hospital Nuremberg & Paracelsus Medical University Nuremberg

  collaborator UNKNOWN

• Instituto de la Retina del Bajio SC (INDEREB)

  collaborator UNKNOWN

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

  collaborator UNKNOWN

• Carmen Clapp

  lead OTHER

Principal Investigators

• Carmen Clapp, Ph.D. · Universidad Nacional Autonoma de Mexico (UNAM)

• Ludivina Robles Osorio, M.D., Ph.D. · Universidad Autónoma de Querétaro

• Renata Garcia Franco, M.D. · Instituto de la Retina del Bajio SC (INDEREB)

• Jakob Triebel, M.D. · Institute for Clinical Chemistry, Laboratory Medicine and Transfusion Medicine, Nuremberg General Hospital

• Marlon R Garcia Roa, M.D. · Instituto Mexicano de Oftalmología (IMO)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

69 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-05-24

Primary Completion

2026-12-31

Completion

2027-06-30

Countries

• Mexico

Study Locations