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Jose Luis Guerrero-Naranjo, Hugo Quiroz-Mercado, Gustavo Sanchez-Bermudez, Fernando Schoonewolff, Samantha Salinas Longoria, Rafael Romero Vera, Weng Tao, Richard Beckman, Virgilio Morales-Canton, Asociacion para Evitar la Ceguera en Mexico I.A.P.; Safety of implantation of the NT-503 device in patients with Choroidal Neovascularization secondary to Age-related Macular Degeneration. Invest. Ophthalmol. Vis. Sci. 2013;54(15):3298.
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To determine the safety and incidence of complications in the surgical implantation of a low dose NT-503 device (Encapsulated Cellular Delivery System producing soluble VEGF receptor - Neurotech, USA) in patients with choroidal neovascularization (CNV) secondary to age related macular degeneration (ARMD).
Single-arm, multi-center, open-label Phase I study. 13 patients with a diagnosis of CNV secondary to ARMD were enrolled in the study at our center from March 2010 to April 2011. Each patient provided informed consent and was screened for eligibility by means of complete eye examination, fluorescein angiography and optical coherence tomography. Implantation was performed on eligible patients under retrobulbar anesthesia. An inferior temporal quadrant peritomy was performed followed by a 2mm sclerotomy at 3.75mm from the limbus, and the device was implanted and fixated to the sclera with 9-0 Prolene. The wound was closed with interrupted 9-0 Nylon sutures, and the peritomy was repaired with interrupted 7-0 vicryl sutures. Topical steroids and antibiotics were administered after the surgery. Follow up was at 1 day, 1 week, 1 month, then every 3 months out to 1 year and included visual acuity (VA), intraocular pressure (IOP), biomicroscopy, indirect ophthalmoscopy, fundus photography, optical coherence tomography (OCT), and fluorescein angiography. Case Report Forms (CRF) were used to report all data and adverse events.
A total of 13 patients, 6 males and 7 females, with a mean age of 71.9 years, were included. All patients were implanted satisfactorily with no intraoperative complications. The most commonly reported post operative complications were retinal hemorrhage (N=4), ocular hyperemia (N=4), ecchymosis (N=2), and conjunctival hemorrhage (N=1). There was one case of uveitis that responded well to topical steroid treatment and the only SAE reported was a death not related to treatment that occurred in one patient with previous diagnosis of prostate cancer.
The present study shows that the NT-503 device can be implanted safely in humans with choroiodal neovascularization secondary to AMD and that the Encapsulated Cellular Delivery System for soluble VEGF receptor warrants further investigation at higher dose levels and in a larger cohort of patients.
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