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 @ 9:40 PM
Ignite Modification Date:
2025-12-24 @ 9:40 PM
NCT ID:
NCT02257632
Eligibility Criteria:
Inclusion Criteria:
* Visual impairment predominantly due to neovascular AMD.
* Active, newly diagnosed, untreated, angiographically documented, CNV lesion (i.e. leakage on fluorescein angiography plus intraretinal, subretinal or sub-RPE fluid on OCT) secondary to neovascular AMD in line with SmPC of ranibizumab and aflibercept
Exclusion Criteria:
* Stroke or myocardial infarction less than 3 months prior to screening.
* Presence of uncontrolled systolic blood pressure or diastolic blood pressure
* Type 1 or Type 2 diabetes mellitus
* Use of any systemic anti-VEGF drugs
* Use of systemic or inhaled corticosteroids for at least 30 consecutive days within 3 months prior to screening.
* Women who are pregnant or breast feeding or who are menstruating and capable of becoming pregnant\* and not practicing a medically approved method of contraception
For either eye:
* Any active periocular or ocular infection or inflammation
* Uncontrolled glaucoma
* Neovascularization of the iris or neovascular glaucoma
* History of treatment with any anti-angiogenic drugs
For study eye:
* Atrophy or fibrosis involving the center of the fovea at the time of screening or baseline.
* Cataract (if causing significant visual impairment), planned cataract surgery during the study period, vitrectomy, aphakia, glaucoma surgery, severe vitreous hemorrhage, rhegmatogenous retinal detachment, proliferative retinopathy or choroidal neovascularization of any other cause than wAMD
* Irreversible structural damage within 0.5 disc diameter of the center of the macula
* Any intraocular procedure (including cataract surgery, Yttrium-Aluminum-Garnet capsulotomy) within 3 months prior to baseline or anticipated within the next 6 months following baseline.
* Use of intravitreal or topical ocular corticosteroids administered for at least 30 consecutive days within 3 months prior to screening.
For fellow eye
\- Retinal or choroidal neovascularization or macula edema of any cause
Other protocol-defined inclusion/exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02257632
Study Brief:
Protocol Section:
NCT02257632