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V. H. Gonzalez, MIVI III Investigators; Microplasmin in Vitrectomy: The MIVI III 6 month Follow-up Results. Invest. Ophthalmol. Vis. Sci. 2009;50(13):2068.
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To evaluate the safety and efficacy of several doses of intravitreal microplasmin versus placebo in patients scheduled for pars plana vitrectomy for treatment of nonproliferative vitreoretinal disease to facilitate the creation of a total posterior vitreous detachment.
This is a multicenter, randomized, placebo controlled, double-masked, parallel-group, dose ranging clinical trial. 125 patients were randomized to 1 of the following: Placebo (31), 25µg (29), 75µg (33), and 125µg (32) intravitreal injection given 7 days (±1 day) prior to surgery. Patients greater than 18 years of age with nonproliferative vitreoretinal disease without evidence of a posterior vitreous detachment over the macula in whom vitrectomy is indicated were eligible.
The microplasmin treatment group demonstrated a dose dependent induction of a posterior vitreous detachment. 10/32 patients in the 125µg group versus 3/30 in the placebo group met the primary end point. 9/32 patients in the 125µg group versus 1/30 in the placebo group had resolution of their condition without the need for surgery. One placebo patient presented with 2 intra-operative retinal detachments while 2 microplasmin-treated patients presented with 2 detachments each. No systemic safety concerns were noted.
Microplasmin is generally well tolerated and able to induce PVD as well as nonsurgical traction release and in some cases nonsurgical macular hole closure. Further evaluation of microplasmin in Phase III clinical trials is warranted.
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