ThromboGenics Completes Patient Enrolment for Phase II Trial of Microplasmin for the Treatment of Diabetic Macular Edema
ThromboGenics NV announced that it has completed patient enrolment for a Phase II trial of microplasmin intravitreal injection for the treatment of Diabetic Macular Edema (MIVI II DME). This trial is designed as the initial step in evaluating the utility of microplasmin in patients with diabetes, a group which is more prone to eye disease such as diabetic retinopathy, due to their underlying medical condition.
The MIVI II DME trial is a Phase II, randomized, double masked, sham injection controlled, dose ascending clinical trial evaluating the safety and initial efficacy of intravitreal microplasmin for the treatment of patients with Diabetic Macular Edema, a particular form of diabetic retinopathy. The trial is primarily intended to evaluate safety in this specific patient population, but will also assess efficacy by measuring the induction of posterior vitreous detachment (PVD). The trial recruited over 50 patients across Europe. Patients are to be followed for 12 months, with first unmasked data analyzed after 6 months follow-up, and to be presented towards the end of 2009.
The Company believes that microplasmin may represent a major advance in this area, as detaching the vitreous from the retina has been associated with greatly reducing the growth of new blood vessels (neovascularization) on the retina, which plays a fundamental role in the loss of vision in many diabetic patients.
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