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:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-25 @ 4:19 AM
NCT ID:
NCT06330220
Eligibility Criteria:
Inclusion Criteria:
* Age equal to or older than 50 years
* Treatment Naïve with active subfoveal choroidal neovascularization (CNV) lesion secondary to age-related macular degeneration (AMD) in the study eye
* Baseline visual acuity equal to or better than 20/40
* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Willingness and ability to undertake all scheduled visits and assessments
Exclusion Criteria:
* Sub- or intra-retinal hemorrhage that comprises more than 50% of the entire lesion in the study eye
* Scar, fibrosis or atrophy involving the center of the fovea in the study eye
* Presence of CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture or pathologic myopia
* Presence of retinal pigment epithelial tears or rips involving the macula in the study eye
* Presence of macular hole at any stage in the study eye
* Any concurrent macular abnormality other than AMD in the study eye including epiretinal membrane, macular telangiectasia, retinal vascular abnormality.
* History of intraocular surgery except cataract operation
* Any previous intravitreal treatment to treat neovascular AMD in study eye.
* Spherical equivalent of the refractive error in the study eye demonstrating more than 8 diopters of myopia
* Presence of glaucoma that affect visual field in the study eye
* Uncontrolled ocular hypertension in the study eye (defined as intraocular pressure ≥ 25 mg despite treatment with anti-glaucoma medication) in the study eye
* History of allergy to the fluorescein sodium for injection in angiography
* History or clinical evidence of diabetic retinopathy much severe than mild non-proliferative diabetic retinopathy or diabetic macular edema in either eye
* Stroke, transient ischemic attacks, or myocardial infarction within 90 days prior to screening
* Prior treatment involving macula with photodynamic therapy with verteporfin, transpupillary thermotherapy, radiation therapy, or retinal laser treatment in the study eye, and such medications will not be allowed during the study period.
* Current use of systemic medications known to be toxic to the lens, retina or optic nerve, including deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines, vigabatrin and ethambutol, and such medications will not be allowed during the study period.
* Patients incapable of performing diagnostic tests for reasons including physical or attention limitation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT06330220
Study Brief:
Protocol Section:
NCT06330220