E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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 |
To investigate the long term efficacy and safety of Anecortave Acetate 15 mg (0.5mL of 30mg/ml Anecortave Acetate Sterile Suspension) in patients who were actively enrolled with at least 24 months of continuous participation in C-98-03, or who have completed an Alcon Anecortave Acetate Phase III study when enrolled in this study |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients must have completed and be currently active in the Alcon C-98-03 study at the time initiation of study C-03-15, with at least 24 months of continuous participation or have completed an Alcon Anecortave Acetate Phase III study at the time they are enrolled in study C-03-15. |
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E.4 | Principal exclusion criteria |
Use of any investigational drug or treatment related or unrelated to ARMD (excluding Anecortave acetate) since discontinuation from the preceding Anecortave Acetate Alcon study, excluding daily vitamin and/or mineral therapy.
Patient is on intravenous or subcutaneous anticoagulent therapy, or patient is on oral anticoagulent therapy (with the exception of aspirin and antiplatelet therapy) and cannot take a 5 day holiday from therapy prior to the injection procedure.
Patients on oral anticoagulant therapy (warfarin or Coumadin®) may be considered for participation in the study if the physician responsible for monitoring the anticoagulant therapy agrees that the patient may take a 5 day "holiday from therapy" prior to each posterior juxtascleral injection which may occur at 6-month intervals (159-180 days since prior administration) as per the Study Plan. The attending physician must notify the Principal Investigator that the patient may be taken off oral anticoagulent therapy and this notification be made part of the source documentation and also included in the comments section of the Case Report Form. This must be done on each occasion that the patient is taken off therapy. Anticoagulant therapy may resume either the evening of or the morning after the injection procedure. Any change in the anticoagulant therapy regimen since the Enrollment Visit must be captured in the source documents and in the Change in Concomitant Medication tables in the Case Report Form. Patients taking aspirin or antiplatelet therapies continue to be eligible for the study and do not require any ‘holiday from therapy.”
Patient with a clinically relevant medical condition or ophthalmic disease (i.e., unstable cardiovascular disease or unstable pulmonary disease) that may preclude safe participation in the study.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy parameters will be the percentage of patients who maintain a positive visual acuity outcome (<3-line loss of logMAR VA), and mean change from baseline in logMAR visual acuity score. |
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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 | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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
| 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 | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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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Last patient visit, 24 months after entering the study. |
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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 | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |