E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Could not load description due to error |
|
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 (0.5 ml of 30 mg/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. 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. |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Patient must be willing to give written informed consent, make the required study visits, and follow instructions. Female patients of childbearing potential (those who are not postmenopausal or surgically sterile) may participate only if they are not lactating, if they have a negative urine pregnancy test at the Initaiation Visit (and prior to each subsequent injection), if they do not intend to become pregnant during the study and if they agree to use adequate birth control methods (hormonal - oral, implantable or injectable chemical contraceptives; mechanical - spermicide in conjunction with a barrier such as condom or diaphragm; IUD; or surgical sterilization of partner) to prevent pregnancy throughout the 24 month study. Urine pregnancy tests will be performed prior to each injection of study drug, and at the Exit Visit on all female patients of childbearing potential. Patient 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 in Alcon study C-98-03, or have completed an Alcon Anecortave Acetate Phase III study at the time they are enrolled in study C-03-15. |
|
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 formonitoring 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. The Medical Monitor may declare any patient ineligible to participate in the study for a sound medical reason. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary statistical objective of this study is to describe the long term safety and efficacy of Anecortave Acetate 15 mg (0.5 mL of 30 mg/mL Anecortave Acetate Sterile Suspension). Summary statistics will be provided at each visit for the primary efficacy evaluations of logMAR visual acuity. These include 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. Mean logMAR score at each visit (i.e., not change from baseline) will also be described. Results will be described for the entirety of treatment across the preceding Ancecortave Acetate trial and current (C-03-15) study. Change from baseline in efficacy outcomes will be described both from the eligibility at time of enrollment in the preceding Anecortave Acetate trial as well as C-03-15 eligibility. The Enrollment Visit (Visit 1) for each study will serve as the baseline in the change from baseline analyses. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
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 | 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
| 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 |
|
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |