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The MIVI‐007 Trial – phase III evaluation of single intravitreous injection of microplasmin or placebo for treatment of focal vitreomacular adhesion
Author(s) -
VAN CALSTER J
Publication year - 2010
Publication title -
acta ophthalmologica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.534
H-Index - 87
eISSN - 1755-3768
pISSN - 1755-375X
DOI - 10.1111/j.1755-3768.2010.3113.x
Subject(s) - medicine , placebo , clinical endpoint , ophthalmology , diabetic retinopathy , vitrectomy , randomized controlled trial , clinical trial , surgery , macular hole , visual acuity , diabetes mellitus , pathology , alternative medicine , endocrinology
Purpose Focal vitreomacular adhesion (fVMA) can result in vitreomacular traction syndrome and macular hole, and is associated with more severe disease in other conditions such as diabetic retinopathy and AMD. The MIVI‐007 trial was a Phase III study to evaluate single injection microplasmin (generic name ocriplasmin) for treatment of fVMA. Methods A Phase III, randomized, placebo controlled, double‐masked clinical trial was designed to investigate intravitreal microplasmin 125 µg in eyes with symptomatic focal VMA. Exclusion criteria included proliferative retinopathy, MH diameter >400um, and prior RD/macular laser/vitrectomy. Subjects were randomized to microplasmin or placebo intravitreous injection (allocation ratio 3:1). Primary endpoint was nonsurgical resolution of fVMA at day 28, determined by Central Reading Centre OCT evaluation. Secondary endpoints included total PVD at day 28, nonsurgical MH closure, nonsurgical VA improvement, and VFQ‐25. Eyes were followed for 6 months. Results 326 eyes were treated. Mean age at baseline was 72 yo, with 68% Female. In addition to focal VMA, 20% had full‐thickness MH (mean MH diameter 300um). The mean baseline BCVA was 64 letters. Endpoint results and 6 month safety results will be presented. Conclusion In Phase II clinical trials, microplasmin has been associated with nonsurgical resolution of focal VMA and MH closure. This Phase III program is the largest trial ever conducted to evaluate a pharmacologic intervention for treatment of focal vitreomacular adhesion.