E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with dry 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 |
Primary objective of this study is to show a superior effect of Prostavasin® compared to placebo on visual acuity in subjects with a dry AMD at 3 months after the end of study drug infusion. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives are to show a superior effect of Prostavasin® compared to placebo on visual acuity immediately after and at 6 months after the end of study drug infusion. Furthermore, a superior effect of Prostavasin® on progression of the dry and on development of a wet AMD as well as on contrast sensitivity and color vision shall be demonstrated. The safety of Prostavasin® infusion will be investigated by means of adverse events, laboratory values, vital signs and ECG at rest. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Male and female subjects older than 50 years of age 2. Dry AMD with hard drusen and possibly with beginning geographic atrophy in one eye (if both eyes are affected, the worse eye will be defined as the "study-eye", if the worse eye fulfills AREDS category 3 or 4, the better eye will be defined as the "study-eye") 3. Visual acuity between 0.2 and 0.7 (logMAR) assessed with ETDRS charts 4. Subject is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent. 5. Subject is willing and able to comply with all trial requirements for a total of 7 months.
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E.4 | Principal exclusion criteria |
Ophtalmologic exclusion criteria 1. Dry AMD AREDS category 3 or 4 in both eyes 2. Wet AMD in at least one eye 3. Detachment of the pigmentary epithelium 4. Glaucoma 5. Diabetic retinopathy 6. Medical history of retinal vein occlusion 7. Uveitis 8. Cataract surgery during the study 9. High myopia (< –6 dpt) with pathological findings of the retina 10. Medical history of any ophthalmic surgery with complications 11. Medical history of cataract surgery without complications within the last 12 weeks 12. Medical history of vitrectomy 13. AREDS medication (vitamin C, beta-carotene, zinc and copper) within the last 2 days 14. Ophthalmologic dietary supplements within the last 2 days 15. Medical history of retinal hemorrhage. Internal medical exclusion criteria: 1. Cardiac failure (NYHA grade II or higher) 2. Inadequately controlled coronary heart disease or cardiac arrhythmia 3. Subject has a medical history and / or suspicion of pulmonary edema or pulmonary infiltration 4. Subject has a peripheral edema 5. Myocardial infarction within 6 months prior to enrollment in this study 6. Subject has renal insufficiency, compensated retention (creatinine > 1.5 mg/dL) 7. Subject has known existing malignant disease 8. Severe chronic obstructive pulmonary disease 9. Subject has a veno-occlusive lung disease 10. Known hepatic disease 11. Inadequately controlled or untreated hypertension (systolic blood pressure ≥ 180 mmHg, diastolic blood pressure ≥ 110 mmHg 12. Subject has upper grade cardiac valvular disorders 13. Pregnancy or lactation period 14. Known hypersensitivity to PGE1 or to any component of the trial medication 15. Subject has a history of chronic alcohol or drug abuse within the past 2 years 16. Subject has known lactose intolerance 17. Poor general state of health or other criteria preventing the subject from complying with the study procedures 18. Subject has other serious illness of the patient that the investigator considers to compromise his/her participation in the trial 19. Laboratory values outside the normal range unless considered not clinically relevant by the investigator.
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary efficacy variable is the difference in visual acuity between measurements at 3 months after the end of study drug infusion and measurements at baseline, which will be assessed as difference in lines with ETDRS.
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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 | Information not present in EudraCT |
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 | 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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
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 | 1 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 1 |