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 @ 6:34 PM
Ignite Modification Date:
2025-12-24 @ 6:34 PM
NCT ID:
NCT05342857
Eligibility Criteria:
Inclusion Criteria:
* -Treatment-naïve patients with subfoveal CNV secondary to wet AMD and PCV, with visual impairment being exclusively due to an symptomatic neovascular AMD.
* \- -Clinical status meet the national reimbursement criteria
Exclusion Criteria:
* \- Any contraindications as listed in the local intravitreal aflibercept package insert
* \- Any active periocular or ocular infection or inflammation at baseline
* \- Uncontrolled glaucoma (intraocular pressure \[IOP\] ≥30 mm Hg on medication) at baseline
* \- Neovascularisation of the iris or neovascular glaucoma at baseline
* \- Visually significant cataract, severe vitreous haemorrhage, rhegmatogenous retinal detachment, proliferative diabetic retinopathy or CNV of any cause other than wet AMD at baseline
* \- Structural damage to the center of the macula in either eye that is likely to preclude improvement in VA following the resolution of macular edema or any other condition expected to permanently limit VA outcomes over the course of the study
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT05342857
Study Brief:
Protocol Section:
NCT05342857