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About
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.
Full description
The aim of this study is to prospectively evaluate the use of aflibercept in patients in whom initial incomplete response or loss of initial response for other intravitreal anti- vascular endothelial growth factor (anti-VEGF) therapy was demonstrated.
This is a multi-center study initiated and conducted by the Israeli retina association. Each center participating in the study will follow the same protocol including standardized measurement of visual acuity, OCT, and Fluorescein angiography (FA).
We will enroll 48 NVAMD patients which are partial or non-responded for 3-6 injections of intravitreal bevacizumab or ranibizumab and no more than one year of treatment .
Test Treatment:
Monthly intravitreal aflibercept 2mg /0.05 ml will be given at enrolment (day 0), 4 weeks, 8 weeks, 16 weeks, and 24 weeks after the initial enrollment for the study group.
Follow-up period will be 28 weeks,7 visits. At the 28 week visit the primary and secondary end points will be evaluated.
Enrollment
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Inclusion criteria
Ophthalmic 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.
General Inclusion Criteria
Subjects of either gender, aged above 50 years.
Women should be post-menopausal for at least 12 months prior to trial entry, or surgically sterile.
Provide written informed consent.
Ability to comply with study and follow-up procedures and return for all trial visits.
Exclusion criteria
Ophthalmic Exclusion Criteria
General Exclusion Criteria
Any of the following underlying diseases including:
Clinically significant impaired renal (serum creatinine >2.5 mg/dl or s/p renal transplant or receiving dialysis) or hepatic function.
Stroke (within 3 months of trial entry).
Any major surgical procedure within one month of trial entry.
Any treatment with an investigational agent in the 60 days prior to trial entry for any condition.
Known serious allergies to the fluorescein dye used in angiography (mild allergy amenable to treatment is allowable), to the components of the bevacizumab, or aflibercept formulation.
Women of child-bearing potential.
Primary purpose
Allocation
Interventional model
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48 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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