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M. D. de Smet, A. Kampik, P. Stalmans, A. Gandorfer, M. Veckeneer, E. Feron; Results of the Phase IIa MIVI Trial: Microplasmin in Vitrectomy Patients With Macular Traction or Macular Holes. Invest. Ophthalmol. Vis. Sci. 2007;48(13):277.
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Microplasmin is a recombinant protein containing the active moiety of plasmin. Given a smaller size than plasmin, it might be capable of better diffusion through the vitreous. In vitro, and in vivo experiments have demonstrated the ability of this compound to induce a posterior hyaloid detachment and alteration of vitreous structure. This initial clinical trial was conducted to determine its safety and provide early efficacy profile.
In a prospective, non-randomized study conducted in 4 clinical centers, patients were recruited for 6 treatment cohorts consisting of 10 patients per cohort. Tested doses were 25, 50, 75 and 125 Âµg of microplasmin. Depending on the cohort, injection was given 1 hour, 1 day or 7 days prior to vitrectomy. Patients with macular hole stage II and III, tractional DME, or macular traction syndromes requiring surgery were eligible.
Evidence of activity was noted in all cohorts but was more evident following prolonged exposure and at higher dose concentration except the highest dose. Side effects were limited: no retinal toxicity was noted on electrophysiology, no ocular inflammation, and minimal cataract formation (nuclear sclerosis) consistent with post-vitrectomy setting was observed 3 months following surgery. One patient developed a retinal detachment starting 2 hours after injection of microplasmin.
Microplasmin is a very promising compound for pharmacologic vitreolysis. Its clinical safety and efficacy profile have so far been promising.
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