Patients with type 2 diabetes mellitus with mild or moderate or severe non-proliferative diabetic retinopathy (NPDR). MedDRA version: 9.1 Level: LLT Classification code 10054109 Term: Non-proliferative diabetic retinopathy
Conditions
Interventions
Trade Name: Cavinton Forte
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Gedeon Richter Plc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with Type 2 diabetes mellitus with mild or moderate or severe non-proliferative diabetic retinopathy (NPDR). • Patients must be treated with diet and/or oral antidiabetics: sulphonylurea (glibenclamid, glipizid, gliclazid…), biguanid (metformin, buformin), thiazolidindion, acarbose and/or insulin. The patient’s diabetological treatment mustn’t be changed significantly during the whole study period. • Age between 30 and 80 years (both males and females). • 18 kg/m2 = BMI = 35 kg/m2 (and the minimal body weight is 40 kg) • The patient’s HgbA1c= 10%. • Signed Informed Consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Other severe concomitant disease (chronic inflammation, endocrine-, hematology disease or malignancy). • Other severe ophtalmological disease (glaucoma, age related macula degeneration, cataracta) that might confound assessment of retinopathy due to diabetes mellitus. • Uncontrolled hypertension (systolic > 180 Hgmm, diastolic > 110 Hgmm). • If QTc > 500 msec. • Any clinically significant abnormality in clinical laboratory tests. Screening haematology and biochemistry laboratory tests must be within defined limits including full blood count within the normal range (or not clinically significantly abnormal), liver enzymes not exceed three times the upper limit of normal range, alkaline phosphatase, bilirubin not exceed twice the upper limit of normal range. • Current treatment with vinpocetine containing drugs. • New treatment for the diabetic retinopathy is not permitted during the course of the study. • Alcohol or drug abuse in the medical history within the past 2 years, or current chronic or intermittent users of illicit drugs. • Known hypersensitivity to vinpocetine or any of the excipients of the product. • Lactose intolerance. • Severe physical or mental (for example: severe dementia) concomitant disorder that might confound the conduct or result of the trial. • Lactating or pregnant women or women of child-bearing potential* without appropriate contraceptive treatment (acceptable methods are used consistently and correctly such as implants, injectables, combined oral contraceptives, IUDs, vasectomised partner or sexual abstinence). • Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study or to cooperate on the necessary level. • Evidence of an uncooperative attitude. • Patients who have participated in a study of an investigational drug or device within 3 months of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the efficacy of Cavinton Forte (vinpocetine) tablet in patients with non-proliferative diabetic retinopathy.;Secondary Objective: To assess the safety and tolerability of Cavinton Forte (vinpocetine) tablet.;Primary end point(s): Exploratoric study with the following efficacy parameters: • Visual acuity with ETDRS (Early Treatment Diabetic Retinopathy Study) chart • IOP (Intra Ocular Pressure) measurement • Fundus photography • Fluorescein angiography • OCT (Optical Coherence Tomography) • VEP (Visual Evoked Potential), PERG (Pattern Electroretinogram) • ERG (Electroretinograph) | — |
Countries
Hungary
Outcome results
None listed