ThromboGenics Announces Results From a Phase IIa Trial Evaluating Microplasmin for the Treatment of Diabetic Macular Edema (MIVI II DME)
News Oct 09, 2009
The MIVI II DME trial was designed to be the initial step in evaluating microplasmin in patients with diabetes, a group which is more prone to eye disease, and specifically diabetic retinopathy. Diabetic retinopathy is a major cause of visual loss and the leading cause of blindness in patients aged 20-60. Previous studies in this advanced patient population have shown that, given the underlying condition, the adhesion between the vitreous and retina tends to be much stronger, as evidenced during vitrectomy. This level of adhesion makes it more challenging to achieve a total PVD in patients with advanced DME, as opposed to earlier stage diabetic retinopathy.
The MIVI II DME trial was a Phase IIa, randomized, double masked, sham injection controlled, dose ascending clinical trial evaluating the safety and initial efficacy of intravitreal microplasmin (25, 75 and 125 µg) for the treatment of patients with Diabetic Macular Edema, a particular form of diabetic retinopathy. The efficacy endpoint was the induction of posterior vitreous detachment (PVD), as assessed by the principal investigator (PI) and the Central Reading Center (CRC) based on ultrasonography. The trial recruited 51 patients across Europe. Patients enrolled in this trial had advanced DME, as evidenced by prior laser treatment in 46% of the sham patients and 76% of the microplasmin-treated patients.
The data showed that microplasmin was safe and well tolerated. The principal investigators found that within three days after microplasmin injection, a total PVD in two out of 15 patients was observed in the 125ug dose group, and by day 28, two additional patients out of 15 in the 75 ug dose group had total PVD. The investigators did not observe total PVD by day 28 in any patients who received 25 µg of microplasmin or the sham injection. The PI results were regarded as giving the most accurate view of microplasmin’s efficacy in this study, due to inherent limitations in the CRC assessment,