Scientific programm: Abstract

5th scientific session: The Upcoming

37. Results of the Microplasmin Phase IIt-Trial in
      Releasing Vitreomacular Traction:
      Rationale for a Phase III-Trial.

Joachim Van Calster (Leuven)

Purpose: Vitreomacular traction (VMT) is a common indication for vitrectomy, which may be avoided using enzymatic vitreolysis. The MIVI–IIT (Traction) study evaluated the ability of a single or repeated injection of microplasmin to release VMT.
Methods: This randomized double-masked phase II trial with control sham injection enrolled 60 patients. Patients in each of four cohorts were randomized to active treatment or sham injection in a 4:1 ratio. In the first three active cohorts, increasing doses of microplasmin (75, 125, and 175 µg) were administered. In the fourth active cohort, a second dose (no sham) was injected 4 weeks after a 125 µg baseline injection if no release of traction occurred. A third dose (no sham) was injected 1 month later if there was still no release of traction.
Results: Within 28 days of sham, 75, 125, and 175 µg microplasmin administration, nonsurgical resolution of VMT was observed in 8%, 25%, 44%, and 27% of the patients, respectively. When the 125 µg dose was repeated up to three times, traction release was observed in 58% of patients 28 days after the final injection.
Conclusion: These results provide support for the potential of microplasmin as a non-invasive treatment for VMT, and provide the rationale for conducting a Phase III study of which recruitment of patients is ongoing.

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