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 @ 6:28 PM
Ignite Modification Date:
2025-12-24 @ 6:28 PM
NCT ID:
NCT00363168
Eligibility Criteria:
Inclusion Criteria:
Subjects will be eligible if the following criteria are met:
* Ability to provide written informed consent and comply with study assessments for the full duration of the study.
* Predominantly hemorrhagic subfoveal CNV (at least 50% of the lesion composed of hemorrhage) from age-related macular degeneration (AMD) resulting in visual acuity of 20/40 or worse.
* Age greater than 50 years.
* Participant must have media clear enough to permit fundus photography, fluorescein angiography, and optical coherence tomography.
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded from this study:
* Known hypersensitivity to humanized monoclonal antibodies
* History (within past 6 months) or evidence of severe cardiac disease (apparent in electrocardiogram abnormalities, clinical history of unstable angina, acute coronary syndrome, myocardial infarction, revascularization procedure within 6 months prior to baseline, atrial or ventricular tachyarrhythmias requiring ongoing treatment).
* History of stroke within 6 months of study entry.
* Current acute ocular or periocular infection.
* Any major surgical procedure within one month of study entry.
* Known serious allergies to fluorescein dye.
* Previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, Protein Kinase C inhibitors, etc) within last 6 months.
* Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye within the last 6 months.
* History of subfoveal laser treatment in the study eye.
* History of other visually-limiting conditions such as optic neuropathy, amblyopia, choroidal neovascularization due to causes other than AMD in the study eye.
* Ocular inflammation (including trace or above) in the study eye.
* Inability to comply with study or follow up procedures.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT00363168
Study Brief:
Protocol Section:
NCT00363168