A Single Injection Of Ocriplasmin For The Treatment Of Symptomatic Vitreomacular Adhesion (sVMA): Results Of The Phase III MIVI-TRUST Program

Abstract

Purpose: : Symptomatic vitreomacular adhesion (sVMA) is implicated in vitreomacular traction syndrome, macular hole, and other conditions such as diabetic retinopathy, PDR, DME, &AMD. A pharmacologic means of resolving vitreomacular adhesion could fill a significant unmet need. Previous experiments have suggested that ocriplasmin, a recombinant truncated form of human plasmin, may be useful for the pharmacologic separation of vitreomacular adhesion. The MIVI-TRUST program is composed of two Phase III trials evaluating ocriplasmin for the treatment of sVMA. Both studies have identical inclusion/exclusion criteria, treatment regimens, and visit schedules, and are therefore suitable for pooling of results.

Methods: : The MIVI-TRUST program consists of the MIVI-006 and the MIVI-007 studies. Both studies are Phase III, multicenter, randomized, placebo controlled, double-masked clinical trials designed to investigate intravitreal ocriplasmin 125 µg for the pharmacological treatment of sVMA. The defined primary endpoint was nonsurgical resolution of fVMA at day 28, determined by Central Reading Centre OCT evaluation. Secondary endpoint assessments included total PVD at day 28, nonsurgical FTMH closure, avoidance of vitrectomy, visual acuity, and VFQ-25. Eyes were followed for 6 months.

Results: : 652 eyes were treated. Mean age at baseline was 72 years. In addition to focal VMA, 23% had FTMH; 39% had ERM; and 6% had diabetic retinopathy. Mean baseline BCVA was 64 letters (Range 8-88). Results demonstrated highly statistically significant improved rate of pharmacological resolution of VMA in ocriplasmin group compared to placebo (p=0.003 and 0.001, respectively). Further, approximately 40% of patients with FTMH at baseline treated with ocriplasmin achieved pharmacological resolution of FTMH.

Conclusions: : The MIVI-TRUST program is the largest Phase III program ever conducted to evaluate a pharmacologic intervention for the treatment of symptomatic vitreomacular adhesion. The significant clinical results observed in these trials indicate that ocriplasmin can potentially become a first line pharmacologic option for the treatment of symptomatic vitreomacular adhesion and macular holes.

Clinical Trial: : http://www.clinicaltrials.gov NCT00798317

Keywords: retinal adhesion • macula/fovea • retina