E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non-exsudative age-related macular degeneration |
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MedDRA Classification |
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 |
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E.2.2 | Secondary objectives of the trial |
Lesion size, cholesterol and fibrinogen levels, plasma viscosity, lutein levels |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
§ Study eye with non-exsudative AMD with > 10 large soft, and / or confluent drusen within 3000 nm of the foveal center - and a best corrected visual acuity using the ETDRS chart between 0,05 to 1,0 inclusive (Snellen 0,05 – 0,8) - with / without geographic atrophy less than 3 disc diameters within 3000 nm of the foveal center - with / without serous pigment epithelial detachment without clearly identifiable neovascularisation § Patients must have elevated baseline concentrations of at least one of the rheologic factors (serum cholesterol level > 200 mg/dL, fibrinogen level > 390 mg/dL, or plasmaviscosity > 1.6 mPa*s) § Patients with adequate bilateral anecubital venous access
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E.4 | Principal exclusion criteria |
§ Study eye with exsudative AMD § Study eye with concomitant retinal or choroidal disorder other than AMD § Study eye with significant central lens opacities and / or conditions that limit the view of the fundus § Study eye with other ocular diseases § Patients who are in poor general health § Patients with a hematocrit < 30%, evidence of active bleeding, or a platelet count < 100,000 k/µL § Patients with significant cardiac problems § Patients with a history (< 12 months) of cardiac infarction § Patients with uncontrolled arterial hypertension § Patients with recent history (< 3 months) of cerebral vascular disease § Patients with uncontrolled diabetes § Patients who are allergic to fluorescein sodium and to indocyanine green § Patients who are unwilling to adhere to visit examination schedules § Patients with a known history of alcoholism, drug abuse, or any other condition that would limit hepatic function and validity of consent § Patients lutein supplement intake § Patients weighing < 45 kg § Patients with carcinoma
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | Yes |
E.6.9 | Dose response | Yes |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
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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If the patient no longer wishes to continue, If the patient feels uncomfortable in the study, If any serious adverse events have been reported about the study medication, If any serious adverse events have occured to the patient. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |