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      2018 Update on Intravitreal Injections: Euretina Expert Consensus Recommendations

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          Abstract

          Intravitreal injections (IVI) have become the most common intraocular procedure worldwide with increasing numbers every year. The article presents the most up-to-date review on IVI epidemiology and techniques. Unfortunately, important issues related to pre-, peri- and postinjection management lack randomized clinical trials for a final conclusion. Also, a great diversity of approaches exists worldwide. Therefore, expert consensus recommendations on IVI techniques are provided.

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          Most cited references 113

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          Pegaptanib for neovascular age-related macular degeneration.

           ,  A Adamis,  Brian Cunningham (2004)
          Pegaptanib, an anti-vascular endothelial growth factor therapy, was evaluated in the treatment of neovascular age-related macular degeneration. We conducted two concurrent, prospective, randomized, double-blind, multicenter, dose-ranging, controlled clinical trials using broad entry criteria. Intravitreous injection into one eye per patient of pegaptanib (at a dose of 0.3 mg, 1.0 mg, or 3.0 mg) or sham injections were administered every 6 weeks over a period of 48 weeks. The primary end point was the proportion of patients who had lost fewer than 15 letters of visual acuity at 54 weeks. In the combined analysis of the primary end point (for a total of 1186 patients), efficacy was demonstrated, without a dose-response relationship, for all three doses of pegaptanib (P<0.001 for the comparison of 0.3 mg with sham injection; P<0.001 for the comparison of 1.0 mg with sham injection; and P=0.03 for the comparison of 3.0 mg with sham injection). In the group given pegaptanib at 0.3 mg, 70 percent of patients lost fewer than 15 letters of visual acuity, as compared with 55 percent among the controls (P<0.001). The risk of severe loss of visual acuity (loss of 30 letters or more) was reduced from 22 percent in the sham-injection group to 10 percent in the group receiving 0.3 mg of pegaptanib (P<0.001). More patients receiving pegaptanib (0.3 mg), as compared with sham injection, maintained their visual acuity or gained acuity (33 percent vs. 23 percent; P=0.003). As early as six weeks after beginning therapy with the study drug, and at all subsequent points, the mean visual acuity among patients receiving 0.3 mg of pegaptanib was better than in those receiving sham injections (P<0.002). Among the adverse events that occurred, endophthalmitis (in 1.3 percent of patients), traumatic injury to the lens (in 0.7 percent), and retinal detachment (in 0.6 percent) were the most serious and required vigilance. These events were associated with a severe loss of visual acuity in 0.1 percent of patients. Pegaptanib appears to be an effective therapy for neovascular age-related macular degeneration. Its long-term safety is not known. Copyright 2004 Massachusetts Medical Society.
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            Dexamethasone intravitreal implant in patients with macular edema related to branch or central retinal vein occlusion twelve-month study results.

            To evaluate the safety and efficacy of 1 or 2 treatments with dexamethasone intravitreal implant (DEX implant) over 12 months in eyes with macular edema owing to branch or central retinal vein occlusion (BRVO or CRVO). Two identical, multicenter, prospective studies included a randomized, 6-month, double-masked, sham-controlled phase followed by a 6-month open-label extension. We included 1256 patients with vision loss owing to macular edema associated with BRVO or CRVO. At baseline, patients received DEX implant 0.7 mg (n = 421), DEX implant 0.35 mg (n = 412), or sham (n = 423) in the study eye. At day 180, patients could receive DEX implant 0.7 mg if best-corrected visual acuity (BCVA) was 250 μm. The primary outcome for the open-label extension was safety; BCVA was also evaluated. At day 180, 997 patients received open-label DEX implant. Except for cataract, the incidence of ocular adverse events was similar in patients who received their first or second DEX implant. Over 12 months, cataract progression occurred in 90 of 302 phakic eyes (29.8%) that received 2 DEX implant 0.7 mg injections versus 5 of 88 sham-treated phakic eyes (5.7%); cataract surgery was performed in 4 of 302 (1.3%) and 1 of 88 (1.1%) eyes, respectively. In the group receiving two 0.7-mg DEX implants (n = 341), a ≥ 10-mmHg intraocular pressure (IOP) increase from baseline was observed in (12.6% after the first treatment, and 15.4% after the second). The IOP increases were usually transient and controlled with medication or observation; an additional 10.3% of patients initiated IOP-lowering medications after the second treatment. A ≥ 15-letter improvement in BCVA from baseline was achieved by 30% and 32% of patients 60 days after the first and second DEX implant, respectively. Among patients with macular edema owing to BRVO or CRVO, single and repeated treatment with DEX implant had a favorable safety profile over 12 months. In patients who qualified for and received 2 DEX implant injections, the efficacy and safety of the 2 implants were similar with the exception of cataract progression. Proprietary or commercial disclosure may be found after the references. Copyright © 2011 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
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              Is Open Access

              Escherichia coli Harboring mcr-1 and blaCTX-M on a Novel IncF Plasmid: First Report of mcr-1 in the United States

              LETTER The recent discovery of a plasmid-borne colistin resistance gene, mcr-1, in China heralds the emergence of truly pan-drug-resistant bacteria (1). The gene has been found primarily in Escherichia coli but has also been identified in other members of the Enterobacteriaceae in human, animal, food, and environmental samples on every continent (2 – 5). In response to this threat, starting in May 2016, all extended-spectrum-β-lactamase (ESBL)-producing E. coli clinical isolates submitted to the clinical microbiology laboratory at the Walter Reed National Military Medical Center (WRNMMC) have been tested for resistance to colistin by Etest. Here we report the presence of mcr-1 in an E. coli strain cultured from a patient with a urinary tract infection (UTI) in the United States. The strain was resistant to colistin, but it remained susceptible to several other agents, including amikacin, piperacillin-tazobactam, all carbapenems, and nitrofurantoin (Table 1). E. coli MRSN 388634 was cultured from the urine of a 49-year-old female who presented to a clinic in Pennsylvania on 26 April 2016 with symptoms indicative of a UTI. The isolate was forwarded to WRNMMC, where susceptibility testing indicated an ESBL phenotype (Table 1). The isolate was included in the first 6 ESBL-producing E. coli isolates selected for colistin susceptibility testing, and it was the only isolate to have a MIC of colistin of 4 μg/ml (all of the others had MICs of ≤0.25 μ/ml). The colistin MIC was confirmed by broth microdilution, and mcr-1 was detected by real-time PCR (6). Whole-genome sequencing (WGS) of MRSN 388634 was performed using a PacBio RS II system and a MiSeq benchtop sequencer. TABLE 1 Antibiotic resistance profile of MRSN 388634 Antibiotic(s) MIC(s) (μg/ml) a Amikacin ≤8, S Amoxicillin/clavulanate 16/8, I Ampicillin >16, R Aztreonam >16, R Cefazolin >16, R Cefepime >16, R Ceftazidime >16, R Ceftriaxone >32, R Ciprofloxacin >2, R Colistin 4, R Ertapenem ≤0.25, S Gentamicin >8, R Imipenem ≤0.25, S Levofloxacin >4, R Meropenem ≤0.25, S Nitrofurantoin ≤16, S Piperacillin-tazobactam 4/4, S Tetracycline >8, R Tobramycin >8, R Trimethoprim-sulfamethoxazole >2/38, R a MICs were determined using BD Phoenix (BD Diagnostics Systems, Hunt Valley, MD, USA) with panels NMIC/ID 133, except for colistin, for which determinations were performed using Etest and manual broth microdilution; both gave MICs of colistin of 4 μg/ml. R = resistant, I = intermediate, and S = susceptible, based on CLSI guidelines (except for colistin, where EUCAST breakpoints are used). E. coli MRSN 388634 belonged to sequence type 457 (ST457), a rare E. coli ST first identified in 2008 from a urine culture in the United Kingdom (7). It was subsequently identified from a bloodstream culture in Italy, where it was found to harbor the carbapenemase genes bla KPC-3 and bla CTX-M-55 (8). MRSN 388634 carried 15 antibiotic resistance genes, which were harbored on two plasmids, but no carbapenemases (Table 2). TABLE 2 Characteristics of plasmids in E. coli MRSN 388634 Plasmid name Size (kb) Inc a Copy no. b Antibiotic resistance genes c pMR0516mcr 225.7 F18:A-:B1 2 strA, strB, bla CTX-M-55, bla TEM-1B, mcr-1 , sul2, tet(A), dfrA14 pMR0416ctx 47 N 1 aac(3)-IVa, aph(4)-Ia, bla CTX-M-14, fosA3, mph(A), floR, sul2 a Data represent plasmid incompatibility (Inc) group designations, as determined by Plasmid Finder version 1.2 (10). b Data represent average numbers of copies per cell, normalized to the chromosomal read coverage. c The gene of interest is indicated in bold. The first plasmid, pMR0516mcr, was 225,707 bp in size and belonged to incompatibility group F18:A-:B1 (9). BLAST analysis indicated that pMR0516mcr represented a novel IncF plasmid. Notably, it shares 89 kb of homologous sequence with pHNSHP45-2, a mcr-1-carrying IncHI2 plasmid described by Liu and colleagues (1). This shared sequence contains mcr-1 in association with ISApl1 (1), but in pMR0516mcr it is in a different location and orientation (Fig. 1). pMR0516mcr also carried 7 additional antibiotic resistance genes, including the ESBL gene bla CTX-M-55 (Table 2). The second plasmid, pMR0416ctx, was ∼47 kb in size and was assigned to IncN (Table 2). It carried 7 antibiotic resistance genes, including bla CTX-M-14. A complete description of both plasmids is under preparation. FIG 1 Comparison of the homologous regions containing mcr-1 shared by pMR0516mcr and pHNSHP45-2. Open arrows represent coding sequences (green arrows, mcr-1; white arrows, ISapl1; purple arrows, metabolic function; blue arrows, plasmid replication and maintenance; gray arrows, hypothetical and unclassified) and indicate direction of transcription. The arrow size is proportional to the gene length. The gray and blue areas between pMR0516mcr and pHNSHP45-2 indicate nucleotide identity of >99.9% by BLASTN. To the best of our knowledge, this is the first report of mcr-1 in the United States. The epidemiology of MRSN 388634 is noteworthy; the isolate was submitted from a clinic in Pennsylvania, and the patient reported no travel history within the prior 5 months. To date, a further 20 ESBL-producing E. coli isolates from patients at the WRNMMC have tested negative for mcr-1 and have been colistin sensitive. However, as testing has been ongoing for only 3 weeks, it remains unclear what the true prevalence of mcr-1 is in the population. The association between mcr-1 and IncF plasmids is concerning, as these plasmids are vehicles for the dissemination of antibiotic resistance and virulence genes among the Enterobacteriaceae (9). Continued surveillance to determine the true frequency for this gene in the United States is critical. Nucleotide sequence accession numbers. The Short Read Archive (SRA) file for MRSN 388623 has been deposited at GenBank with accession number SRP075674. The complete sequence of pMR0516mcr has been deposited at GenBank with accession no. KX276657.
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                Author and article information

                Journal
                OPH
                Ophthalmologica
                10.1159/issn.0030-3755
                Ophthalmologica
                S. Karger AG
                0030-3755
                1423-0267
                2018
                May 2018
                01 February 2018
                : 239
                : 4
                : 181-193
                Affiliations
                aDepartment of Ophthalmology, University of Warmia and Mazury, Olsztyn, Poland
                bInstitute for Research in Ophthalmology, Foundation for Ophthalmology Development, Poznan, Poland
                cDepartment of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria
                dDepartment of Ophthalmology, Vita-Salute University, San Raffaele Hospital, Milan, Italy
                eDepartment of Ophthalmology, Sackler Faculty of Medicine, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel
                fDepartment of Ophthalmology, Sackler Faculty of Medicine, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel
                Author notes
                *Andrzej Grzybowski, MD, PhD, MBA, Institute for Research in Ophthalmology, Gorczyczewskiego 2/3, PL–61-553 Poznan (Poland), E-Mail ae.grzybowski@gmail.com
                Article
                486145 Ophthalmologica 2018;239:181–193
                10.1159/000486145
                29393226
                © 2018 S. Karger AG, Basel

                Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

                Page count
                Tables: 1, Pages: 13
                Categories
                Review Article

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