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Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 300

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.
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

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.

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