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Enzymatic Vitreolysis with Ocriplasmin for Vitreomacular Traction and Macular Holes

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Enzymatic Vitreolysis with Ocriplasmin for Vitreomacular Traction and Macular Holes 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. Vitreo- are listed in the Supplementary Appen- macular adhesion resolved in 26.5% of ocriplasmin-injected eyes and in 10.1% of dix, available at NEJM.org. placebo-injected eyes (P<0.001). Total posterior vitreous detachment was more prev- N Engl J Med 2012;367:606-15. alent among the eyes treated with ocriplasmin than among those injected with DOI: 10.1056/NEJMoa1110823 placebo (13.4% vs. 3.7%, P<0.001). Nonsurgical closure of macular holes was Copyright © 2012 Massachusetts Medical Society. achieved in 40.6% of ocriplasmin-injected eyes, as compared with 10.6% of placebo- injected eyes (P<0.001). The best-corrected visual acuity was more likely to improve by a gain of at least three lines on the eye chart with ocriplasmin than with placebo. Ocular adverse events (e.g., vitreous floaters, photopsia, or injection-related eye pain — all self-reported — or conjunctival hemorrhage) occurred in 68.4% of ocriplasmin- injected eyes and in 53.5% of placebo-injected eyes (P<0.001), and the incidence of serious ocular adverse events was similar in the two groups (P = 0.26). CONCLUSIONS Intravitreal injection of the vitreolytic agent ocriplasmin resolved vitreomacular traction and closed macular holes in significantly more patients than did injection of placebo and was associated with a higher incidence of ocular adverse events, which were mainly transient. (Funded by ThromboGenics; ClinicalTrials.gov num- bers, NCT00781859 and NCT00798317.) 606 n engl j med 367;7 nejm.org august 16, 2012 The New England Journal of Medicine Downloaded from nejm.org by NICOLETTA TORTOLONE on August 16, 2012. For personal use only. No other uses without permission. Copyright © 2012 Massachusetts Medical Society. All rights reserved. Vitreolysis for Vitreomacular Traction and Macular Holes he human vitreous body is bounded components of the vitreoretinal interface. Results posteriorly by the retina and is variably ad- of preclinical and clinical studies have suggested herent to it. Collagen fibrils forming the that ocriplasmin can induce vitreous liquefaction T 17,18,20 posterior vitreous cortex are firmly attached at the and separation from the retina. Phase 2 stud- macula, the central part of the retina where visual ies have shown that intravitreal injection of a acuity is best, and are connected to its internal lim- single 125-μg dose of ocriplasmin or up to three iting membrane by means of a biochemical glue injections of 125 μg each given monthly can in- composed of proteoglycans, including laminin and duce the resolution of vitreomacular traction and fibrinectin.1-4 With aging, the gel-like vitreous closure of macular holes without causing serious progressively liquefies and vitreoretinal adhesions adverse events.1,21 weaken, leading to separation of the vitreous from the retina, or posterior vitreous detachment.5-7 Methods Vitreomacular adhesion is observed after partial posterior vitreous detachment, when a portion STUDY DESIGN AND OVERSIGHT of the posterior vitreous remains attached to the We performed two multicenter, randomized, macula. When traction increases in response to double-blind, placebo-controlled, phase 3 studies anteroposterior forces, tangential forces, or both, (TG-MV-006 and TG-MV-007, hereafter called study the adhesion may cause vitreomacular traction and 006 and study 007) to test the efficacy and safety become symptomatic. Symptoms typically include of a single intravitreal injection of ocriplasmin. metamorphopsia and blurring of visual acuity with Patients were randomly assigned to intravitreal in- central visual-field defects. Vitreomacular traction jection of either ocriplasmin or placebo. Owing to can lead to macular distortion and edema and to a specific recommendation by the Food and Drug the formation of macular holes.8 It has been sug- Administration, the ratio of randomized assign- gested that vitreomacular adhesion may play a role ments to ocriplasmin and placebo in study 006 was in the progression of diabetic retinopathy and age- changed to 2:1, and the randomization ratio in related macular degeneration.1,9-12 Vitrectomy is study 007 was 3:1 from the outset. Otherwise, the the only treatment for vitreomacular traction and study protocols were identical. In study 006, en- macular holes, and because it poses certain risks rollment began on December 23, 2008, and was (infection, retinal detachment, hemorrhage, and completed on September 4, 2009. In study 007, en- cataract), it is usually withheld until loss of vi- rollment began on December 22, 2008, and was sion has become clinically significant. completed on September 17, 2009. The studies were Vitreolysis involving an enzyme that has activ- approved by the institutional review board or in- ity against the molecular substrates responsible dependent ethics committee at each participating for vitreomacular adhesion is a potential nonsur- site, and we obtained written informed consent gical, biologic approach to the treatment of this from all patients before they were enrolled. disorder. Substances directed against biochemical Both trials were designed, coordinated, and components of the vitreomacular interface, such as sponsored by ThromboGenics. The data were gath- chondroitinase, dispase, and hyaluronidase, have ered independently by the Microplasmin for In- been tested but were abandoned because of insuf- travitreous Injection — Traction Release without ficient clinical efficacy, complications, or both.13-15 Surgical Treatment (MIVI-TRUST) study groups Plasmin and a truncated form of plasmin, ocriplas- and were analyzed by contract research organiza- min (formerly microplasmin), have been shown tions paid by ThromboGenics. The authors wrote to be effective in ex vivo studies of vitreolysis in the manuscript and made the decision, in consul- animals and humans.16-18 Such an approach to tation with ThromboGenics, to submit it for pub- symptomatic vitreomacular adhesion could allow lication. The authors attest that the studies were nonsurgical intervention, treatment at an earlier performed in accordance with the protocols, in- stage of the disease, or both, which would prob- cluding the statistical analysis plans, available with ably result in better outcomes.1,7,13-15,19 the full text of this article at NEJM.org. The au- Ocriplasmin is a truncated form of the human thors vouch for the accuracy and completeness of serine protease plasmin and has proteolytic activ- the reported results and for the fidelity of this re- ity against fibronectin and laminin, two major port to the study protocols. n engl j med 367;7 nejm.org august 16, 2012 607 The New England Journal of Medicine Downloaded from nejm.org by NICOLETTA TORTOLONE on August 16, 2012. For personal use only. No other uses without permission. Copyright © 2012 Massachusetts Medical Society. All rights reserved. T h e new england journal o f medicine INCLUSION AND EXCLUSION CRITERIA with pupillary dilation), B-scan ultrasonography Patients were eligible for the study if they were at to evaluate the status of the posterior vitreous least 18 years of age and had focal vitreomacular cortex, OCT to document the status of vitreo- adhesion, defined as vitreous adhesion to the mac- macular adhesion and the presence or absence of ula within a 6-mm central retinal field surrounded a macular hole, fundus photography, and fluo- by elevation of the posterior vitreous cortex, as seen rescein angiography. Patients completed the self- on optical coherence tomography (OCT), and a administered National Eye Institute Visual Func- best-corrected visual acuity of 20/25 or less in the tioning Questionnaire–25
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