E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with type 2 diabetes mellitus with mild or moderate or severe non-proliferative diabetic retinopathy (NPDR). |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054109 |
E.1.2 | Term | Non-proliferative diabetic retinopathy |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate the efficacy of Cavinton Forte (vinpocetine) tablet in patients with non-proliferative diabetic retinopathy. |
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E.2.2 | Secondary objectives of the trial |
To assess the safety and tolerability of Cavinton Forte (vinpocetine) tablet. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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)
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |