ThromboGenics has completed patient enrollment for a phase II trial of microplasmin intravitreal injection for the treatment of diabetic macular edema, according to a statement issued by the company.
-ThromboGenics has completed patient enrollment for a phase II trial of microplasmin intravitreal injection for the treatment of diabetic macular edema (MIVI II DME), according to a statement issued by the company.
The randomized, double-masked, sham-injection controlled, dose-ascending clinical trial is primarily designed to evaluate the safety and initial efficacy of the injections for the treatment of patients with DME, but it also will assess efficacy by measuring the induction of posterior vitreous detachment, the company said.
The more than 50 patients who were recruited from across Europe will receive follow-up for 12 months. The first unmasked data will be analyzed after 6 months follow-up and presented toward the end of this year.
“We are very pleased to announce the completion of enrollment in MIVI II DME,” said Steve Pakola, MD, chief medical officer of ThromboGenics. “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 only approved treatment for patients with DME is laser photocoagulation; however, this treatment does not improve vision once it is lost. Currently, in patients who do not have a response to laser photocoagulation, vitrectomy is used as a treatment, as vitreomacular adhesion is thought to play an important role in the disease, according to the statement.
ThromboGenics is a biotechnology company focused on innovative treatments for eye disease, vascular disease, and cancer.