Pharmacologic Vitreolysis: Clinical Trial Data
Pharmacologic vitreolysis refers to the administration of an agent to induce vitreous liquefaction and/or vitreoretinal separation in an attempt to treat vitreoretinal disorders. Enzymes that target one or more of the substrates that make up the vitreous
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Steve Pakola and Julia A. Haller
11.1
Introduction
11.1.1 Why Pharmacologic Vitreolysis? Recognition of the importance of vitreo-macular interface pathology in various retinal disorders has grown in recent years (Sebag 2004; Johnson 2010), in large part due to the remarkable advances in imaging of the vitreoretinal interface made possible by optical coherence tomography. In particular, anomalous PVD with remaining vitreo-macular adhesion (VMA) is increasingly recognized, as well as its pathologic sequelae of vitreo-macular traction and macular hole. Vitreomacular adhesion has also been implicated in the exacerbation of other retinal disorders, including retinal vein occlusion, diabetic retinopathy, and age-related macular degeneration (Avunduk et al 1997; Nasrallah et al 1988; Akiba et al 1990; Haller et al 2010; Krebs et al 2007; Mojana et al 2008; Robison et al 2009). Patients with VMT and macular hole have a poor prognosis if left untreated. Most untreated eyes undergo a further decrease in vision and in some cases progressive complications (Hikichi S. Pakola, MD (*) Clinical Development, Amakem NV, 15 Lewis Rd, Irvington, NY 10533, USA e-mail: [email protected] J.A. Haller, MD Wills Eye Institute, 840 Walnut Street, Suite 1510, Philadelphia, PA 19107, USA e-mail: [email protected]
et al. 1995). In patients with symptomatic VMA who underwent vitrectomy, greater improvement in visual acuity was observed in eyes with better preoperative visual acuity and shorter duration of symptoms (Melberg et al. 1995; Sonmez et al. 2008). Thus, the data suggest that earlier treatment of this spectrum of disorders may help achieve better visual outcome. Nevertheless, the invasiveness, risks, expense, and inconvenience of vitrectomy typically limit its use to patients with advanced disease (Guillaubey et al. 2007; Ramkissoon et al. 2010; Rizzo et al. 2010; Banker et al. 1997; Cheng et al. 2001; Freeman et al. 1997; Recchia et al. 2010). Therefore, patients often remain untreated until the condition progressively worsens to a point that warrants surgery. The goal of therapy for symptomatic VMA and related conditions is to relieve traction on the macula thereby resolving the underlying condition with subsequent functional improvement. The only treatment option available currently to achieve this goal is surgery (vitrectomy). A minimally invasive, less traumatic, and well-tolerated pharmacological treatment option would represent a significant advance in care. It is for these reasons that the retina community has over the last two decades advanced pharmacologic vitreolysis as a potential treatment option for addressing diseases of the vitreo-macular interface like symptomatic VMA as well as for treatment of other retinal diseases where vitreo-macular interface pathology may play an exacerbating role. Pharmacologic vitreolysis refers to the
A. Girach, M.D. de Smet (eds.), Diseases of the Vitreo-Macular Interface, Essentials in Ophthalmology, DOI 10.1007/978-3-642-40034-6_11, © Springer-Verlag Berlin Heidelberg 2014
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