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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
INTARAVITREAL INJECTION OF AFLIBERCEPT
Hadassah Medical Organization
Jerusalem, Israel
Central macular thickness change
Central macular thickness change from baseline on optical coherence tomography (OCT) at week 28.
Time frame: at week 28
change in best corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity and Change in CNV size
1. The mean change in best corrected ETDRS visual acuity at 4 meters according to a standardized protocol. 2. Gain or loss of 3-lines of visual acuity as defined above. 3. Change in CNV size according to fluorescein angiogram, following a standardized protocol.
Time frame: at week 28
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.