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Emmanuel Chang, MIC Study Group; Ocriplasmin as an Adjunct to Vitrectomy for the Treatment of Pediatric Patients: Results of the MIC Trial. Invest. Ophthalmol. Vis. Sci. 2013;54(15):1964.
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The ocriplasmin MIC trial was a phase 2, single-center, randomized, double-masked, placebo-controlled study to determine efficacy and safety of ocriplasmin versus placebo as a preoperative adjunct to vitrectomy in pediatric patients.
The MIC trial included pediatric vitrectomy candidates 16 years or younger (including infants) with vitreous attachment to the posterior pole. Patients were randomized to receive a single intravitreal injection of 175 µg ocriplasmin (n=16) or placebo (n=8) 30-60 minutes before planned start of vitrectomy. The primary end point was total macular posterior vitreous detachment (PVD) as assessed by masked surgeon under an operating microscope at the beginning of vitrectomy. Selected secondary end points included investigator assessment of vitreous liquefaction at the beginning of vitrectomy; immediate postoperative retinal reattachment status; presence of postoperative proliferative vitreoretinopathy and retinopathy of prematurity (ROP) classification by fluorescein angiography on follow-up. Selected safety assessments included adverse event reports and B scan ultrasonography.
The trial is complete with findings to be reported in early 2013. Vitreous detachment status was measured on a 3-point grade scale with Grade 0 being no PVD at beginning of vitrectomy and Grade 3 being total PVD without disc attachment. Vitreous liquefaction status was measured on scale of 1 (formed gel) to 4 (water consistency). Postoperative retinal reattachment status was scored as present or absent immediately after vitrectomy. Postoperative ROP classification on follow-up was scored according to a 5-stage scale with Stage 1 defined by presence of a faint demarcation line and Stage 5 by total retinal detachment.
Findings from the MIC trial may be informative for physicians seeking adjunct treatments to support vitrectomy outcomes in pediatric patients.
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