The Phase IIa MIVI-IIT trial was a sham injection controlled study in which patients were assigned to receive either 75(micro)g or 125(micro)g of microplasmin. Analysis of the full follow-up of these patients showed benefits from therapy with 10 of the 24 microplasmin treated patients seeing resolution of their vitreomacular traction without the need for vitrectomy.
In most of these patients this success was achieved shortly after microplasmin treatment. In contrast, only one of the six sham injected patients had non-surgical resolution of their vitreomacular traction and this took the full six months to achieve.
The full six month follow-up results demonstrate that the success in terms of resolution of the vitreomacular traction has translated into clinical benefit for these patients. None of the sham treated patients were able to achieve this very important clinical end point. The full six month follow-up results of these patients also showed that microplasmin therapy continued to be well tolerated.
Given the excellent safety of microplasmin in the trial to-date, the size of this trial has been doubled by the addition of two further cohorts of 15 patients. The third cohort of patients receive a higher 175(micro)g dose of microplasmin while the fourth cohort receive repeated monthly injections of 125(micro)g of microplasmin. All 60 patients have now been enrolled into the trial.