T h e new england journal o f medicine original article Enzymatic Vitreolysis with Ocriplasmin for Vitreomacular Traction and Macular Holes Peter Stalmans, M.D., Ph.D., Matthew S. Benz, M.D., Arnd Gandorfer, M.D., Anselm Kampik, M.D., Aniz Girach, M.D., Stephen Pakola, M.D., and Julia A. Haller, M.D., for the MIVI-TRUST Study Group* ABSTRACT BACKGROUND From the Department of Ophthalmolo- Vitreomacular adhesion can lead to pathologic traction and macular hole. The standard gy, Universitaire Ziekenhuizen Leuven, treatment for severe, symptomatic vitreomacular adhesion is vitrectomy. Ocriplasmin Leuven, Belgium (P.S.); Retina Consul- tants of Houston, Houston (M.S.B.); the is a recombinant protease with activity against fibronectin and laminin, components Department of Ophthalmology, Klinikum of the vitreoretinal interface. der Universität Munich, Munich (A. Gan- dorfer, A.K.), and Medizinisches Versor- gungszentrum, Memmingen (A. Gan- METHODS dorfer) — both in Germany; Thrombo- We conducted two multicenter, randomized, double-blind, phase 3 clinical trials to Genics, Heverlee, Belgium (A. Girach, compare a single intravitreal injection of ocriplasmin (125 μg) with a placebo injec- S.P.); and Wills Eye Institute, Philadelphia (J.A.H.). Address reprint requests to Dr. tion in patients with symptomatic vitreomacular adhesion. The primary end point Haller at the Wills Eye Institute, 840 Wal- was resolution of vitreomacular adhesion at day 28. Secondary end points were total nut St., Suite 1510, Philadelphia, PA, posterior vitreous detachment and nonsurgical closure of a macular hole at 28 days, 19107, or at
[email protected]. avoidance of vitrectomy, and change in best-corrected visual acuity. *Investigators participating in the Micro- plasmin for Intravitreous Injection — RESULTS Traction Release without Surgical Treat- ment (MIVI-TRUST) clinical program Overall, 652 eyes were treated: 464 with ocriplasmin and 188 with placebo.