ThromboGenics Completes Patient Enrolment for Phase II Trial of Microplasmin for the Treatment of DME
News Mar 09, 2009
ThromboGenics NV announces 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.
Diabetic retinopathy is a major cause of visual loss and the leading cause of blindness in patients aged 20-60. Diabetic Macular Edema (DME) is a condition where swelling of the retina occurs in patients with diabetic retinopathy, due to a leakage of fluid from blood vessels within the macula.
The only approved treatment for patients with DME is laser photocoagulation; however, this treatment does not improve vision once it is lost. In patients who do not respond to laser photocoagulation, vitrectomy (the surgical procedure used to produce a PVD) is currently used as a treatment, as vitreomacular adhesion is thought to play an important part in the disease.
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.
Dr. Steve Pakola, Chief Medical Officer of ThromboGenics, commented, “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.”