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 @ 12:59 PM
Ignite Modification Date:
2025-12-24 @ 12:59 PM
NCT ID:
NCT03558061
Eligibility Criteria:
Inclusion Criteria:
* Men and women with newly diagnosed active CNV secondary to AMD, diagnosed by a retinal specialist with all the following characteristics and ophthalmic inclusion criteria applied to the study eye:
* No prior treatment for wAMD in the study eye and no current or planned concomitant intravitreal anti-VEGF treatment in the fellow eye
* Central subfield retinal thickness ≥ 250 microns on SD-OCT (exclusive of subretinal pigment epithelial fluid, inclusive of SRF)
* Presence of SRF and/or IRF on SD-OCT
* Any active CNV with subfoveal leakage as determined by FA
* Total lesion size not greater than 12 disc areas on FA
* If present, subretinal hemorrhage must comprise \< 50% of the total lesion area on FA
* No subfoveal fibrosis or atrophy on FA
* BCVA letter score, as measured by ETDRS in the study eye, between 70 and 24 letters, inclusive, at screening
* Patients 50 years of age or older at screening visit 1
* Body mass index (BMI) between18 and ≤ 40 at screening visit 1
* Female subjects must not be pregnant or breastfeeding. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry.
* Signed informed consent consistent with ICH-GCP guidelines and local legislation prior to participation in the trial, which includes medication washout and restrictions
Exclusion Criteria:
* Previous participation in any studies of investigational drugs within 1 month preceding screening visit
* Any form of macular degeneration that is not age-related (e.g., Best's disease, Stargardt's disease, Sorsby's disease, etc.)
* Additional eye disease in the study eye that could compromise BCVA (i.e., uncontrolled glaucoma (intraocular pressure \> 24) with visual field loss, clinically significant diabetic maculopathy, history of ischemic optic neuropathy or retinal vascular occlusion, vitreomacular traction, monocular vision, or genetic disorders such as retinitis pigmentosa; high myopia \> 8 diopters)
* The presence of polypoidal choroidal vasculopathy (PCV) or retinal angiomatous proliferation (RAP) in the study eye
* Anterior segment and vitreous abnormalities in the study eye that would preclude adequate observation with fundus photography/FA or SD-OCT
* Intraocular surgery in the study eye within 3 months prior to screening
* Aphakia or total absence of the posterior capsule (yttrium aluminum garnet (YAG) laser capsulotomy permitted, a minimum of 1 month prior to enrollment) in the study eye
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT03558061
Study Brief:
Protocol Section:
NCT03558061