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      Computer-Based Visual Evaluation as a Screening Tool after Intravitreal Injections of Vascular Endothelial Growth Factor Inhibitors


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          Purpose: To evaluate the visual acuity (VA) of patients following intravitreal (IVT) injections. Methods: 15 patients received 3 anti-vascular-endothelial-growth-factor (VEGF) injections on a monthly basis. Prior to each injection as well as 2 months after, the patients received a standardized examination including Snellen VA and optical coherence tomography (OCT). During this time the patients were trained to evaluate their central VA by 3 computer-based tests: (a) VA was examined by the patient on a computer-based vision chart and (b) subjectively categorized as ‘same’, ‘worse’ or ‘better’; (c) the edge of metamorphopsia was outlined on a digital Amsler grid. Results: VA improved during the 3 injections by ≥2 lines (13/15). The assessment demonstrated subjective improvement (13/15), i.e. a gain of 2 or more lines or decreased central metamorphopsia (12/15). Reevaluation 2 months later demonstrated a decline of ≥1 Snellen line or increased retinal thickness on OCT (8/15), and a decline of ≥1 line or an enlarged metamorphopsia in the computer-based tests (6/15). Conclusion: Our pilot study demonstrated a good correlation between the professional examination and the computer-based assessment. Selected patients can define their visual impairment. A web-based VA evaluation may help to screen patients after IVT injections on a regular basis at home.

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          An optical coherence tomography-guided, variable dosing regimen with intravitreal ranibizumab (Lucentis) for neovascular age-related macular degeneration.

          To evaluate an optical coherence tomography (OCT)-guided, variable-dosing regimen with intravitreal ranibizumab for the treatment of patients with neovascular age-related macular degeneration (AMD). Open-label, prospective, single-center, nonrandomized, investigator-sponsored clinical study. In this two-year study, neovascular AMD patients with subfoveal choroidal neovascularization (CNV) (n = 40) and a central retinal thickness of at least 300 microm as measured by OCT were enrolled to receive three consecutive monthly intravitreal injections of ranibizumab (0.5 mg). Thereafter, retreatment with ranibizumab was performed if one of the following changes was observed between visits: a loss of five letters in conjunction with fluid in the macula as detected by OCT, an increase in OCT central retinal thickness of at least 100 microm, new-onset classic CNV, new macular hemorrhage, or persistent macular fluid detected by OCT at least one month after the previous injection of ranibizumab. At month 12, the mean visual acuity improved by 9.3 letters (P < .001) and the mean OCT central retinal thickness decreased by 178 microm (P < .001). Visual acuity improved 15 or more letters in 35% of patients. These visual acuity and OCT outcomes were achieved with an average of 5.6 injections over 12 months. After a fluid-free macula was achieved, the mean injection-free interval was 4.5 months before another reinjection was necessary. This OCT-guided, variable-dosing regimen with ranibizumab resulted in visual acuity outcomes similar to the Phase III clinical studies, but required fewer intravitreal injections. OCT appears useful for determining when retreatment with ranibizumab is necessary.
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            Randomized, double-masked, sham-controlled trial of ranibizumab for neovascular age-related macular degeneration: PIER Study year 1.

            To evaluate the efficacy and safety of ranibizumab administered monthly for three months and then quarterly in patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). Phase IIIb, multicenter, randomized, double-masked, sham injection-controlled trial in patients with predominantly or minimally classic or occult with no classic CNV lesions. Patients were randomized 1:1:1 to 0.3 mg ranibizumab (n = 60), 0.5 mg ranibizumab (n = 61), or sham (n = 63) treatment groups. The primary efficacy endpoint was mean change from baseline visual acuity (VA) at month 12. Mean changes from baseline VA at 12 months were -16.3, -1.6, and -0.2 letters for the sham, 0.3 mg, and 0.5 mg groups, respectively (P < or = .0001, each ranibizumab dose vs sham). Ranibizumab arrested CNV growth and reduced leakage from CNV. However, the treatment effect declined in the ranibizumab groups during quarterly dosing (e.g., at three months the mean changes from baseline VA had been gains of 2.9 and 4.3 letters for the 0.3 mg and 0.5 mg doses, respectively). Results of subgroups analyses of mean change from baseline VA at 12 months by baseline age, VA, and lesion characteristics were consistent with the overall results. Few serious ocular or nonocular adverse events occurred in any group. Ranibizumab administered monthly for three months and then quarterly provided significant VA benefit to patients with AMD-related subfoveal CNV and was well tolerated. The incidence of serious ocular or nonocular adverse events was low.
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              A computerized method of visual acuity testing


                Author and article information

                S. Karger AG
                December 2008
                12 August 2008
                : 222
                : 6
                : 364-368
                Department of Ophthalmology, Philipps-University, Marburg, Germany
                151246 Ophthalmologica 2008;222:364–368
                © 2008 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.

                : 14 December 2006
                : 13 May 2007
                Page count
                Figures: 3, References: 16, Pages: 5
                Original Paper

                Vision sciences,Ophthalmology & Optometry,Pathology
                Vascular endothelial growth factor inhibitors,Reinjection,Age-related macular degeneration,Visual acuity, computer-based tests,Intravitreal injection,Choroidal neovascularization


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