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      Intravitreal Anti-Vascular Endothelial Growth Factor Therapy for Diabetic Macular Edema in Clinical Practice of Single Center: Three-Year Outcomes

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          Abstract

          Introduction: The objective of this study was to explore visual and anatomical outcomes in patients who underwent intravitreal anti-vascular endothelial growth factor (anti-VEGF) injection for visual impairment from center-involved diabetic macular edema (CI-DME) in clinical practice. Methods: Medical records of consecutive CI-DME patients who initiated treatment with intravitreal bevacizumab injection between January 2012 and December 2016 and were followed for at least 12 months were retrospectively reviewed. Visual and anatomical changes after treatment over a 36-month period were evaluated. Results: There were 286 patients (423 eyes) with a mean (standard deviation, SD) age of 56.8 (8.5) years included in this study. One hundred and forty-six (51%) patients were female, and 137 (47.9%) patients received bilateral eye treatment. Mean (SD) presenting visual acuity (VA) of overall eyes was 50.2 (19.6) letter scores. Stratified by baseline vision, eyes with initial VA worse than 20/40 achieved a statistically significant VA improvement, compared to baseline, by +8.4, +6.9, and +5.4 letters at 12, 24, and 36 months, respectively, with all p values <0.001. However, when initial VA was 20/40 and better, a non-statistically significant change in mean VA by +2.0, −3.5, and −3.6 letters were noted at the same time point ( p value between 0.078 and 0.273). Unlike visual changes, a statistically significant decline in central subfield thickness compared to baseline was noted at the end of months 12, 24, and 36 in both initial VA subgroups (all p values <0.001). Nevertheless, even though the median number of given injections considerably decreased from 6 in the first 12 months to 2 in the second 12-month period and 1 in the final 12-month interval, required ophthalmic clinic visits decreased in frequency with median numbers of 10, 7, and 6 appointments in each consecutive 12-month duration. Conclusion: This study supports the benefits of practical intravitreal anti-VEGF utilization to manage CI-DME in real-world settings. The improvement of vision in eyes presenting with poor baseline VA and maintenance of vision in eyes with better baseline VA were demonstrated through the 3-year review of each case. However, the burden of frequent monitoring warrants further evaluation of long-term compliance and efficacy.

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          Global Prevalence and Major Risk Factors of Diabetic Retinopathy

          OBJECTIVE To examine the global prevalence and major risk factors for diabetic retinopathy (DR) and vision-threatening diabetic retinopathy (VTDR) among people with diabetes. RESEARCH DESIGN AND METHODS A pooled analysis using individual participant data from population-based studies around the world was performed. A systematic literature review was conducted to identify all population-based studies in general populations or individuals with diabetes who had ascertained DR from retinal photographs. Studies provided data for DR end points, including any DR, proliferative DR, diabetic macular edema, and VTDR, and also major systemic risk factors. Pooled prevalence estimates were directly age-standardized to the 2010 World Diabetes Population aged 20–79 years. RESULTS A total of 35 studies (1980–2008) provided data from 22,896 individuals with diabetes. The overall prevalence was 34.6% (95% CI 34.5–34.8) for any DR, 6.96% (6.87–7.04) for proliferative DR, 6.81% (6.74–6.89) for diabetic macular edema, and 10.2% (10.1–10.3) for VTDR. All DR prevalence end points increased with diabetes duration, hemoglobin A1c, and blood pressure levels and were higher in people with type 1 compared with type 2 diabetes. CONCLUSIONS There are approximately 93 million people with DR, 17 million with proliferative DR, 21 million with diabetic macular edema, and 28 million with VTDR worldwide. Longer diabetes duration and poorer glycemic and blood pressure control are strongly associated with DR. These data highlight the substantial worldwide public health burden of DR and the importance of modifiable risk factors in its occurrence. This study is limited by data pooled from studies at different time points, with different methodologies and population characteristics.
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            Randomized trial evaluating ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema.

            Evaluate intravitreal 0.5 mg ranibizumab or 4 mg triamcinolone combined with focal/grid laser compared with focal/grid laser alone for treatment of diabetic macular edema (DME). Multicenter, randomized clinical trial. A total of 854 study eyes of 691 participants with visual acuity (approximate Snellen equivalent) of 20/32 to 20/320 and DME involving the fovea. Eyes were randomized to sham injection + prompt laser (n=293), 0.5 mg ranibizumab + prompt laser (n=187), 0.5 mg ranibizumab + deferred (> or =24 weeks) laser (n=188), or 4 mg triamcinolone + prompt laser (n=186). Retreatment followed an algorithm facilitated by a web-based, real-time data-entry system. Best-corrected visual acuity and safety at 1 year. The 1-year mean change (+/-standard deviation) in the visual acuity letter score from baseline was significantly greater in the ranibizumab + prompt laser group (+9+/-11, P<0.001) and ranibizumab + deferred laser group (+9+/-12, P<0.001) but not in the triamcinolone + prompt laser group (+4+/-13, P=0.31) compared with the sham + prompt laser group (+3+/-13). Reduction in mean central subfield thickness in the triamcinolone + prompt laser group was similar to both ranibizumab groups and greater than in the sham + prompt laser group. In the subset of pseudophakic eyes at baseline (n=273), visual acuity improvement in the triamcinolone + prompt laser group appeared comparable to that in the ranibizumab groups. No systemic events attributable to study treatment were apparent. Three eyes (0.8%) had injection-related endophthalmitis in the ranibizumab groups, whereas elevated intraocular pressure and cataract surgery were more frequent in the triamcinolone + prompt laser group. Two-year visual acuity outcomes were similar to 1-year outcomes. Intravitreal ranibizumab with prompt or deferred laser is more effective through at least 1 year compared with prompt laser alone for the treatment of DME involving the central macula. Ranibizumab as applied in this study, although uncommonly associated with endophthalmitis, should be considered for patients with DME and characteristics similar to those in this clinical trial. In pseudophakic eyes, intravitreal triamcinolone + prompt laser seems more effective than laser alone but frequently increases the risk of intraocular pressure elevation. Copyright 2010 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
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              Ranibizumab for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE.

              To evaluate the efficacy and safety of intravitreal ranibizumab in diabetic macular edema (DME) patients. Two parallel, methodologically identical, phase III, multicenter, double-masked, sham injection-controlled, randomized studies. Adults with vision loss from DME (best-corrected visual acuity [BCVA], 20/40-20/320 Snellen equivalent) and central subfield thickness ≥275 μm on time-domain optical coherence tomography (OCT). Monthly intravitreal ranibizumab (0.5 or 0.3 mg) or sham injections. Macular laser was available per-protocol-specified criteria. Proportion of patients gaining ≥15 letters in BCVA from baseline at 24 months. In RISE (NCT00473330), 377 patients were randomized (127 to sham, 125 to 0.3 mg, 125 to 0.5 mg). At 24 months, 18.1% of sham patients gained ≥15 letters versus 44.8% of 0.3-mg (P<0.0001; difference vs sham adjusted for randomization stratification factors, 24.3%; 95% confidence interval [CI], 13.8-34.8) and 39.2% of 0.5-mg ranibizumab patients (P<0.001; adjusted difference, 20.9%; 95% CI, 10.7-31.1). In RIDE (NCT00473382), 382 patients were randomized (130 to sham, 125 to 0.3 mg, 127 to 0.5 mg). Significantly more ranibizumab-treated patients gained ≥15 letters: 12.3% of sham patients versus 33.6% of 0.3-mg patients (P<0.0001; adjusted difference, 20.8%; 95% CI, 11.4-30.2) and 45.7% of 0.5-mg ranibizumab patients (P<0.0001; adjusted difference, 33.3%; 95% CI, 23.8-42.8). Significant improvements in macular edema were noted on OCT, and retinopathy was less likely to worsen and more likely to improve in ranibizumab-treated patients. Ranibizumab-treated patients underwent significantly fewer macular laser procedures (mean of 1.8 and 1.6 laser procedures over 24 months in the sham groups vs 0.3-0.8 in ranibizumab groups). Ocular safety was consistent with prior ranibizumab studies; endophthalmitis occurred in 4 ranibizumab patients. The total incidence of deaths from vascular or unknown causes, nonfatal myocardial infarctions, and nonfatal cerebrovascular accidents, which are possible effects from systemic vascular endothelial growth factor inhibition, was 4.9% to 5.5% of sham patients and 2.4% to 8.8% of ranibizumab patients. Ranibizumab rapidly and sustainably improved vision, reduced the risk of further vision loss, and improved macular edema in patients with DME, with low rates of ocular and nonocular harm. Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
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                Author and article information

                Journal
                ORE
                Ophthalmic Res
                10.1159/issn.0030-3747
                Ophthalmic Research
                S. Karger AG
                0030-3747
                1423-0259
                2021
                June 2021
                14 October 2020
                : 64
                : 3
                : 483-493
                Affiliations
                [_a] aDepartment of Ophthalmology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand
                [_b] bDepartment of Family Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand
                [_c] cClinical Epidemiology and Clinical Statistics Center, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand
                [_d] dDepartment of Surgery, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand
                Author information
                https://orcid.org/0000-0001-5972-0270
                Article
                512300 Ophthalmic Res 2021;64:483–493
                10.1159/000512300
                33053556
                8e065138-c6d3-41a2-b353-86ae1e2921e1
                © 2020 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.

                History
                : 21 July 2020
                : 10 October 2020
                Page count
                Figures: 4, Tables: 4, Pages: 11
                Categories
                Research Article

                Vision sciences,Ophthalmology & Optometry,Pathology
                Diabetic macular edema,Anti-vascular endothelial growth factor,Visual impairment

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