Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2025-12-24 @ 3:36 PM
NCT ID:
NCT00088192
Eligibility Criteria:
Inclusion Criteria:
* Best corrected visual acuity in the study eye between 20/40 and 20/320.
* Subfoveal choroidal neovascularization, secondary to age related macular degeneration, with a total lesion size \[including blood, scar/atrophy \& neovascularization\] of \< 12 total disc areas, of which at least 50% must be active CNV.
* Any subretinal hemorrhage must comprise no more than 50% of total lesion size.
General Criteria:
* Patients of either gender, aged greater than 50 years.
* Women must be using two forms of effective contraception, or be post-menopausal for at least 12 months prior to study entry, or surgically sterile. If of child-bearing potential, a serum pregnancy test must be performed within 48 hours prior to treatment and the result made available prior to treatment initiation. The two forms of effective contraception must be implemented during the study and for at least 60 days following the last dose of test medication.
* Written informed consent.
Exclusion Criteria:
* Any subfoveal scarring or atrophy and no more than 25% of the total lesion size may be made up of scarring or atrophy.
* Patients who are eligible for PDT with Visudyne
* Patients who are eligible for any other of the Sponsor's ongoing AMD studies still open to enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT00088192
Study Brief:
Protocol Section:
NCT00088192