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ThromboGenics completes enrollment for phase 2 trial of microplasmin for treating DME
LEUVEN, Belgium — ThromboGenics has completed patient enrollment for a phase 2 trial evaluating the safety and initial efficacy of intravitreal microplasmin for treating patients with diabetic macular edema, the company announced in a press release.
The randomized, double-masked, sham injection-controlled, dose-ascending MIVI II DME (Microplasmin intravitreal injection for the treatment of diabetic macular edema) trial will evaluate efficacy by measuring the induction of posterior vitreous detachment. The trial recruited more than 50 patients across Europe. Patients will be followed for a total of 12 months, with initial unmasked data to be analyzed after 6 months and presented by the end of the year.
"We are very pleased to announce the completion of enrollment in MIVI II DME," Steve Pakola, MD, ThromboGenics' chief medical officer, said in the release. "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."
The study is ThromboGenics' first step in evaluating the utility of microplasmin in patients with diabetes.