age related macular degeneration
Conditions
Sponsors
Alcon Research, Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: None;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. | — |
Countries
Germany, Hungary, Italy, Spain, Sweden, United Kingdom
Outcome results
None listed