PROSPECTIVE, RANDOMIZED, SIGLE MASKED PILOT STUDY ON THE VARIATION OF CHOROIDAL BLOOD FLOW ANALYZED THROUGH THE HRA DYNAMIC ANGIOGRAPHY IN PATIENTS TREATED WITH INTRAVITREAL INJECTION OF SELECTIVE ANTI-VEGF (MACUGEN) OR PAN ANTI-VEGF (AVASTIN).
Progetto La terapia anti-VEGF costituisce la nuova terapia della forma vascolare della degenerazione maculare senile. Vi sono attualmente due forme di anti-VEGF quella selettiva sull'isoforma 165 e quella che blocca tutta la molecola. La risposta al trattamento è differente. Scopo dello studio è valutare l'effetto delle due terapie sul flusso ematico dei neovasi coroideali.
Description of the study:
Primary objective for this trial is to assess the difference in choroidal blood flow between ¿Selective¿ anti-VEGF (Macugen) and ¿Pan¿ anti-VEGF (Avastin).
Secondary Objectivies are to assess safety an cumulative toxic effect of ¿Selective¿ anti-VEGF (Macugen) and ¿Pan¿ anti-VEGF (Avastin)
TRIAL DESIGN
A total of 20 patients with advanced wet Age-related Macular Degeneration will be enrolled for this study.
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
1 Subject of either gender aged between 50 and 80.
2 Women must be post-menopausal (since 24 month at least) or surgically sterile or in case of childbearing potential , use two forms of contraception.
3 Provide written informed consent.
4 Evidence of AMD with choroidal neovascularization
5 Clear ocular media and adequate pupillary dilatation to permit good quality fundus images.
All these patients will be randomized in two groups. Group A will receive a ¿Selective¿ anti-VEGF Therapy and Group 2 will receive a ¿Pan¿ anti-VEGF therapy.
All patients will be examined with dynamic fluorescein (FA) and Indocyanine green (ICG) angiography using confocal scanning laser ophthalmoscope. The dynamic angiographies will be performed for both groups of patients before the administration of anti-VEGF and one day, one week, six weeks, 12 weeks and 18 weeks after the first injection.
At visit 1, prior the first treatment, a best corrected visual acuity assesment and an Optical Coherence Tomography (OCT), in addition to ophthalmic examination, will be performed on all enrolled subjects.
The choroidal blood flow mesurement will be performed by means a software produced by Likcenbrock LLC, Albany NY - This software allows an automatic and interactive measure of peak of dye intensity and the filling time
Primary Endpoint:
The mean variation of choroidal blood flow evaluated by dynamic angiography and processed by a specific software.
Secondary endpoints:
The mean variation of visual acuity measured by ETDRS Charts
The mean variation of macular thickness measured by OCT
Safety Endpoints:
Safety assessments will include all adverse events as observed/reported from baseline (Except those relate to progression of neovascular AMD).