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ThromboGenics Completes Enrolment of Patients for the Vitreomacular Traction Trial (MIVI IIT)

25 Sep 2007 - ThromboGenics NV announces that it has completed patient enrolment for the Phase IIa MIVI IIT trial evaluating the safety and efficacy of microplasmin for the treatment of vitreomacular traction, including macular holes.
 
Vitreomacular traction is a condition in which the vitreous gel has an abnormally strong adhesion to the retina and could lead to decreased or distorted central vision as well as vision threatening complications such as retinal tears/detachments and macular holes. These conditions are currently treated by surgical vitrectomy (surgery that removes the vitreous to induce posterior vitreous detachment, or PVD) to release the traction.
 
MIVI IIT is a Phase IIa, sham injection controlled, dose ascending (75, 125 g) trial, which recruited a total of 30 patients in Europe. The lead investigator for this trial is Professor Peter Stalmans from Leuven, Belgium. While the study remains masked, initial data showed that microplasmin was well tolerated in both treatment cohorts. Additionally, PVD induction was observed in a number of patients and in some cases led to the non-surgical resolution of traction and even macular hole closure with improvement in vision, preventing the need for vitrectomy. This preliminary examination of patients shows that microplasmin has the potential to relieve the traction and prevent the need for surgery.