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 @ 11:37 PM
Ignite Modification Date:
2025-12-24 @ 11:37 PM
NCT ID:
NCT01469156
Eligibility Criteria:
Inclusion Criteria:
* Males and Females \>18 years of age. Females of child bearing potential will undergo urine pregnancy testing and be required to use appropriate methods of birth control.
* ICG and fluorescein angiographic characteristics consistent with active, leaking PCV with subfoveal lesions and/or subfoveal hemorrhage, lipid exudates, PED or fluid diagnosed within the past 6 months or diagnosed as newly active within the past 6 months. Subjects who completed the 24 month follow up in the original FVF3671s protocol may enter the study without necessarily demonstrating active exudative PCV at enrollment.
* Best-Corrected ETDRS Visual Acuity at 4 meters between 20/20 - 20/800.
* Lesion size - no limitations.
* Lesions Characteristics - leaking lesions consistent with PCV. No limitations on hemorrhage, fibrosis or atrophy.
* No therapy (includes non foveal laser, PDT, intravitreal steroids, TTT, radiotherapy, or anti-VEGF therapy) or intraocular surgery within the past 30 days for any condition.
* Clear ocular media to allow for photography/angiography.
* Ability to provide written informed consent and comply with study assessments for the full duration of the study.
Exclusion Criteria:
* Patients with features of age related macular degeneration such as abundant drusen and demographic features consistent with this diagnosis.
* Allergy to Fluorescein, ICG, Iodine, Shellfish.
* Pregnancy (positive pregnancy test)
* Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
* Participation in another simultaneous medical investigation or trial.
* Exclude other anti-VEGF agents as therapy options.
* History of previous subfoveal laser.
* Advanced glaucoma (IOP \> 25 or cup/disc ration \> 0.8)
* Any condition in the opinion of the investigator that would interfere with disease status/progression or jeopardize patients' participation in the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01469156
Study Brief:
Protocol Section:
NCT01469156