May 2007
Volume 48, Issue 13
ARVO Annual Meeting Abstract  |   May 2007
Results of the Phase IIa MIVI Trial: Microplasmin in Vitrectomy Patients With Macular Traction or Macular Holes
Author Affiliations & Notes
  • M. D. de Smet
    Ophthalmology, ZNA Middelheim, Antwerp, Belgium
  • A. Kampik
    Augenklinik, LMU, Munchen, Germany
  • P. Stalmans
    Ophthalmology, UZ Leuven, Leuven, Belgium
  • A. Gandorfer
    Augenklinik, LMU, Munchen, Germany
  • M. Veckeneer
    Oogziekenhuis, Rotterdam, The Netherlands
  • E. Feron
    Ophthalmology, ZNA Middelheim, Antwerp, Belgium
  • Footnotes
    Commercial Relationships M.D. de Smet, Ista Pharmaceuticals, C; TG Ltd, P; TG Ltd, R; A. Kampik, TG Ltd, R; P. Stalmans, None; A. Gandorfer, None; M. Veckeneer, None; E. Feron, None.
  • Footnotes
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Investigative Ophthalmology & Visual Science May 2007, Vol.48, 277. doi:
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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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      © ARVO (1962-2015); The Authors (2016-present)

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Purpose:: 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.

Methods:: 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 µg 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.

Results:: 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.

Conclusions:: Microplasmin is a very promising compound for pharmacologic vitreolysis. Its clinical safety and efficacy profile have so far been promising.

Clinical Trial:: 2005-07-21

Keywords: vitreous • vitreoretinal surgery • drug toxicity/drug effects 

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