Aflibercept (EYLEA)as Secondary or Third Line Treatment for Neovascular Age-related Macular Degen… (NCT01918878) | Clinical Trial Compass
UnknownPhase 4
Aflibercept (EYLEA)as Secondary or Third Line Treatment for Neovascular Age-related Macular Degeneration.
Israel48 participantsStarted 2013-10
Plain-language summary
This is a prospective, multicenter, single arm study. The study group will be compose of NVAMD patients who had partial or complete failure responding to initial bevacizumab or ranibizumab treatment of 3-6 monthly intravitreal injections. The patients in the study groups will receive 5 intravitreal injections of aflibercept 2mg/0.05ml at specific visits. Aflibercept will be provided for total period of 24 weeks.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Failure of previous intravitreal bevacizumab or ranibizumab treatment, defined as:
. Subfoveal choroidal neovascularization (CNV) due to AMD as documented by fluorescein angiogram.
. Best corrected visual acuity in the study eye between 20/40 and 20/360, inclusive. The VA must be re-confirmed at Day 0 prior to initiation of treatment.
. Total area of the lesion (including blood, neovascularization, and scar/atrophy) must be ≤ 5 disc areas (DA), of which at least 50% must be active CNV. Active CNV is defined as the neovascular component of the lesion as defined by the fluorescein angiogram.
. Presence on OCT of subretinal, intraretinal or sub-retinal pigment epithelial (RPE) fluid and/or subretinal thickening consistent with active CNV.
. Clear ocular media and adequate pupillary dilatation
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses aflibercept (EYLEA) as a second or third-line treatment, meaning after other anti-VEGF drugs haven't worked well enough — does my treatment history make this worth discussing as a next step for me?
2The trial is measuring changes in central macular thickness as its main outcome — can you explain what that measurement means for my vision, and whether changes in macular thickness typically translate into real-world improvements in how well I can see?
3Since this is a Phase 4 trial, the drug is already approved, but it's being studied in a specific switch-therapy situation — does the existing safety data on aflibercept give you enough confidence in its risk profile, or are there side effects I should still be watching for closely?
4The recruitment status for this trial is listed as unknown, which may mean it's no longer actively enrolling — can you check whether this study is still open, and if not, are there similar trials or established protocols for switching to aflibercept that we could consider instead?
5If I've already tried one or two other anti-VEGF injections without the results I hoped for, is switching to aflibercept through a trial like this a better path forward than simply trying it as a standard off-trial treatment?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. More than 50% of the total lesion size consisting of subretinal hemorrhage.
. Presence of retinal angiomatous proliferation (RAP).
. Presence of pigment epithelial tears.
. Hypersensitivity to the active substance aflibercept or to any of the excipients.
. Active or suspected ocular or periocular infection.
. Active severe intraocular inflammation (≥ trace cell or flare), significant epiretinal membrane or vitreomacular traction, macular hole or vitreous hemorrhage.
. Aphakia or absence of the posterior capsule. Absence of an intact posterior capsule is allowed if it occurred as a result of YAG laser posterior capsulotomy in association with prior posterior chamber intraocular lens (IOL) implantation.
. History of idiopathic or autoimmune-associated uveitis in either eye.