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 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT02140151
Eligibility Criteria:
Inclusion Criteria:
* Adult over 50 years old
* Able to sign informed consent and comply with the study protocol for the duration of two years
* Nonexudative age-related macular degeneration (AMD) in one eye (study eye)
* History of exudative AMD in one eye only (fellow eye) diagnosed within 5 years of study enrollment
Exclusion Criteria:
* Participation in another simultaneous medical investigation or clinical trial
* Patient is pregnant, lactating, or premenopausal and not using adequate contraception
* Known serious allergies to ranibizumab, fluorescein dye, drugs for pupillary dilation, topical anesthetic, sterilizing solution (e.g. Betadine solution)
* Presence of ocular conditions with increased risk of choroidal neovascularization (CNVM) or pigment epithelial detachment (PED), including presumed ocular histoplasmosis syndrome (POHS), traumatic choroidal rupture, angioid streaks, pathologic myopia (spherical equivalent of ≥ -8 diopters or axial length of ≥ 25 mm), multifocal choroiditis, macular choroidal nevus, polypoidal choroidal vasculopathy (PCV), idiopathic central serous chorioretinopathy (ICSC), etc.
* History of vitrectomy in the study eye
* History of cataract surgery within 3 months of enrollment
* History of yttrium aluminum garnet (YAG) capsulotomy within 1 month of enrollment
* History of intraocular or periocular corticosteroid therapy within the past 90 days
* History of therapeutic radiation in the region of the study eye.
* Presence of media opacity that would preclude adequate examination and/or imaging
* Concurrent macular conditions that would affect the study parameters (epiretinal membrane, macular hole, macular edema) or require treatment within the duration of the study
* Any progressive ocular condition (uncontrolled glaucoma, diabetic retinopathy, uveitis) that may affect the visual acuity for the duration of the study
* Active ocular infection (i.e., bacterial, viral, parasitic, or fungal) in either eye at enrollment
* Presence of any advanced systemic condition that may hinder the patients participation and completion of the study
* Concurrent use of systemic anti-VEGF therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT02140151
Study Brief:
Protocol Section:
NCT02140151