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

Sponsor
Carmen Clapp
Study ID
NCT03161652
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 69 Years
Healthy Volunteers
Not accepted

Interventions

  • DME lactose pill — 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.
  • DME levosulpiride — DRUG
    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.
  • DR lactose pill — DRUG
    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.
  • DR levosulpiride — DRUG
    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.
  • DR vitrectomy lactose pill — DRUG
    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.
  • DR vitrectomy levosulpiride — DRUG
    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.
  • DME plus ranibizumab lactose pill — DRUG
    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.
  • DME plus ranibizumab levosulpiride — DRUG
    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.

Study Details

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

Key Dates

First listed
May 22, 2017
Start date
May 24, 2017
Status verified
Nov 2025
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: DME lactose pill
    Patients with DME will be randomized to take a lactose pill (placebo).
  • Experimental: DME levosulpiride
    Patients with DME will be randomized to take levosulpiride.
  • Placebo Comparator: DR lactose pill
    Patients with non-proliferative DR will be randomized to take a lactose pill (placebo)
  • Experimental: DR levosulpiride
    Patients with non-proliferative DR will be randomized to take levosulpiride
  • Placebo Comparator: 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).
  • Experimental: DR, vitrectomy levosulpiride
    Patients with proliferative DR (undergoing medically prescribed vitrectomy 7 days after starting the study) will be randomized to take levosulpiride.
  • Placebo Comparator: 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)
  • Experimental: DME plus ranibizumab levosulpiride
    Patients with DME that will receive intravitreal antiangiogenic therapy with ranibizumab will be randomized to take levosulpiride

Primary Outcome Measure

Visual acuity [ Time Frame: 5 minutes ]

Central Contacts

Related Studies