Health TrialsbyHealthPanel

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

ConditionsDiabetic Macular EdemaDiabetic Retinopathy
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

120 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: DME lactose pillPlacebo comparator 1 intervention
Group B: DME levosulpirideExperimental treatment 1 intervention
Group C: DR lactose pillPlacebo comparator 1 intervention
Group D: DR levosulpirideExperimental treatment 1 intervention
Group E: DR, vitrectomy lactose pillPlacebo comparator 1 intervention
Group F: DR, vitrectomy levosulpirideExperimental treatment 1 intervention
Group G: DME plus ranibizumab lactose pillPlacebo comparator 1 intervention
Group H: DME plus ranibizumab levosulpirideExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Visual acuity

Number of letters recognized in the Early Treatment Diabetic Retinopathy Study (ETDRS) chart test after correcting for any refractive error (myopia, hyperopia, or astigmatism)

Time frame
5 minutes
2

Retinal thickness

Retinal thickness is evaluated by non-invasive optical coherence tomography (OCT) imaging via qualitative and quantitative analyses. For qualitative analyses, OCT images approaching the histological level of retinal morphology are interpreted based on normal and diseased features (hyper-reflective or hypo-reflective lesions, shadowing, and anatomical changes). Quantitative analysis evaluates retinal reflective signals and their correlation with retinal morphology by computer image-processing algorithms (retinal thickness map, volume, area, 1, 3, and 6 mm ETDRS circle diameters).

Time frame
Pupils are dilated (eye drops) for 10 to 15 minutes and optical coherence tomography (OCT) images recorded during 5 minutes.
3

Retinal hard exudates and hemorrhages

Number, size, and location of retinal hard exudates and hemorrhages evaluated by indirect ophthalmoscopy

Time frame
Pupils are dilated (eye drops) for 10 to 15 minutes and fundus images recorded during 5 minutes
4

Retinal microaneurisms, leakage area, cotton-wool spots, venous beading, microvascular and vascular abnormalities

Location, intensity, and source of above alterations evaluated by fundus fluorescein angiography imaging qualitative and quantitative analysis of hyper-fluorescent or hypo-fluorescent regions.

Time frame
Pupils are dilated (eye drops) for 10 to 15 minutes and fundus images recorded before and at different times (0.5 to 5 minutes) after fluorescein injection.

Secondary outcomes

1

Pyruvic glutamic transaminase (TGP) and thyroid stimulating hormone (TSH) serum levels

U/L (TGP) and uU/mL (TSH) quantified in serum samples by the Bioclin Kinetic Transaminase ALT (TGP) Kit and the automatic quimioluminescent evaluator (TSH)

Time frame
1-2 minutes (duration of blood withdrawal)
2

Blood glycated hemoglobin and creatinine serum levels

Glycated hemoglobin (evaluated by boronate affinity chromatography) and creatinine (evaluated by the Jaffe reaction) levels are expressed as % and mg/dL, respectively.

Time frame
1-2 minutes (duration of blood withdrawal)
3

Blood pressure

Systolic and diastolic values in mmHg

Time frame
5 minutes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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
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