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 range50 Years
SexALL
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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
✓. Intraocular pressure (IOP) of 21 mmHg or less.
✓. Subjects of either gender, aged above 50 years.
Exclusion criteria
✕. 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.