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7
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English
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Documents
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2014
Description
ThromboGenics Initiates Major Post-ThromboGenics Initiates Major Post- Marketing Patient Trial with JETREA® in the US PR Newswire LEUVEN, Belgium, March 4, 2014 Ocriplasmin Research to Better Inform Treatment (ORBIT) study designed to generate further data on the "real world" use of ®JETREA ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines for the back of the eye, today announces ®that it is to shortly initiate a US Phase IV study with JETREA . The Ocriplasmin Research to Better Inform Treatment (ORBIT) study is ®designed to generate further data on the real-world use of JETREA . The ORBIT study will recruit 1,500 patients with symptomatic vitreomacular adhesion (VMA)/vitreomacular traction (VMT) patients across 120 retina centers in the US. The prospective, observational study will assess clinical ®outcomes and safety of JETREA administered in a real-world setting for the treatment of symptomatic VMA/VMT by assessing both anatomical and functional outcomes. The study will look at a number of parameters including resolution of VMA, Full Thickness Macular Hole (FTMH) closure, changes in visual acuity (VA) and occurrence and time to vitrectomy. It will also monitor adverse drug reactions (ADRs) and changes from baseline in ocular signs and symptoms across time.
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Publié par
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Publié le
04 mars 2014
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Langue
English