This is s randomized, multi-center, double blind, 3 arm, phase I/II pilot study to evaluate the safety and efficacy of treatment with ORA102 combined with Avastin (Bevacizumab) versus Avastin alone, in patients with neo-vascular age related macular degeneration (AMD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
96
treatment with intravitreal injections of Avastin 1.25mg (0.05ml)and ORA102
treatment with intravitreal injections of Avastin 1.25mg (0.05ml)
Barzilai Medical Center
Ashkelon, Israel
RECRUITINGCarmel Medical Center
Haifa, Israel
RECRUITINGHadassah Medical center Israel
Jerusalem, Israel
RECRUITINGThe incidence and severity of ocular adverse events, including retinal detachment, increase in IOP, cataract, tearing of the retina, decrease in vision, RPE atrophy, and vitreous hemorrhage, will be evaluated.
Time frame: 32 weeks
Central Retinal thickness and presence of intra/sub-retinal fluid observed by OCT at week 32
Time frame: 32 weeks
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Ziv Medical Center
Safed, Israel
RECRUITINGTel-Aviv Sourasky Medical Center
Tel Aviv, Israel
RECRUITING