ThromboGenics completes enrollment in Phase II diabetic macular edema trial

Published: 10-Mar-2009

Initial step in evaluating the utility of microplasmin in patients with diabetes

ThromboGenics, a biotechnology company, has completed patient enrollment for a Phase II trial of microplasmin intravitreal injection for the treatment of diabetic macular edema.

According to the company, 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 microplasmin intravitreal injection for the treatment of diabetic macular edema (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.

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. The trial recruited over 50 patients across Europe. Patients are to be followed for 12 months, with first unmasked data analyzed after six months follow-up, and to be reported towards the end of 2009.

Steve Pakola, chief medical officer of ThromboGenics, said: We are very pleased to announce the completion of enrolment in MIVI II DME. This initial study is an important first step in evaluating microplasmin's effect in the diabetic retinopathy population in general. Microplasmin could represent an important treatment option for this patient population, given numerous studies from various groups showing the clinical benefits of vitreous detachment in diabetic retinopathy.

No items to display

Tell your friend about this article