gms | German Medical Science

Purpose: Vitreomacular adhesion (VMA) is implicated in the pathobiology of idiopathic vitreomacular traction (VMT) and macular hole (MH), and is associated with more severe disease in other conditions such as diabetic retinopathy, DME, and AMD.

Methods: Two multi-center Phase III trials were performed evaluating ocriplasmin for the treatment of VMT, including MH. The studies were multicenter, randomized, placebo controlled, double-masked clinical trials designed to investigate the effect of 125 µg ocriplasmin intravitreally injected. Exclusion criteria included proliferative retinopathy, AMD, MH diameter >400 um, high myopia, prior RD/macular laser/vitrectomy. Subjects were randomized to ocriplasmin or placebo injection. The defined primary endpoint was nonsurgical resolution of VMA at day 28, determined by Central Reading Centre OCT evaluation. Secondary endpoint assessments included total PVD at day 28, nonsurgical MH closure, avoidance of vitrectomy, visual acuity, and VFQ-25. Eyes were followed for 6 months.

Results: 652 eyes were treated (326 in each study). Mean age at baseline was 72 y.o. (Range 18 to 97), with 67% Female and 92% Caucasian. In addition to focal VMA, 23% had full-thickness MH; 39% had ERM; and 6% had diabetic retinopathy. The mean baseline BCVA was 64 letters (Range 8–88).

Both trials 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 MH at baseline treated with ocriplasmin achieved pharmacological resolution of MH.

Conclusion: Ocriplasmin is the first product available with proven clinical efficacy to non-surgically treat vitreomacular traction, including macular holes. Presently, it is commercially available as “Jetrea” in the US and Europe.