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      About Ophthalmologica: 2.1 Impact Factor I 5.1 CiteScore I 0.992 Scimago Journal & Country Rank (SJR)

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      Minimally Invasive Microincision Vitrectomy Surgery with an Intraoperative Dexamethasone Implant for Refractory Diabetic Macular Edema

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          Abstract

          Purpose: To evaluate the 1-year results of 25-gauge microincision vitrectomy surgery (MIVS25) combined with intraoperative dexamethasone (DEX) implant for persistent diabetic macular edema (DME). Methods: This study enrolled patients who had a history of DME for ≥12 months and underwent MIVS25 and DEX implant injection. Best corrected visual acuity (BCVA) and central retinal thickness (CRT) were assessed postoperatively. Results: Eighteen eyes were included in the analysis. Preoperatively, logMAR BCVA was 0.90 and CRT was 594 µm on average. CRT decreased until the 3-month follow-up visit and tended to increase at 6 months, but stabilized at 12 months with additional treatments in five eyes at 5 months postoperatively. Statistically significant improvement in BCVA was noted 1 month after treatment and at each subsequent follow-up visit (p < 0.001). Conclusion: MIVS25 combined with DEX implant injection might be utilized as an effective and safe alternative treatment for intractable DME.

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          Expanded 2-year follow-up of ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema.

          Michael Elman, Neil Bressler, Haijing Qin … (2011)
          To report expanded 2-year follow-up of a previously reported randomized trial evaluating 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 of 20/32 to 20/320 (approximate Snellen equivalent) and DME involving the fovea. Continuation of procedures previously reported for the randomized trial. Best-corrected visual acuity and safety at the 2-year visit. At the 2-year visit, compared with the sham + prompt laser group, the mean change in the visual acuity letter score from baseline was 3.7 letters greater in the ranibizumab + prompt laser group (95% confidence interval adjusted for multiple comparisons [aCI], -0.4 to +7.7), 5.8 letters greater in the ranibizumab + deferred laser group (95% aCI, +1.9 to +9.8), and 1.5 letters worse in the triamcinolone + prompt laser group (95% aCI, -5.5 to +2.4). After the 1- to 2-year visit in the ranibizumab + prompt or deferred laser groups, the median numbers of injections were 2 and 3 (potential maximum of 13), respectively. At the 2-year visit, the percentages of eyes with central subfield thickness ≥250 μm were 59% in the sham + prompt laser group, 43% in the ranibizumab + prompt laser group, 42% in the ranibizumab + deferred laser group, and 52% in the triamcinolone + prompt laser group. No systemic events attributable to study treatment were apparent. Three eyes in 3 (0.8%) of 375 participants had injection-related endophthalmitis in the ranibizumab groups, whereas elevated intraocular pressure and cataract surgery were more frequent in the triamcinolone + prompt laser group. The expanded 2-year results reported are similar to results published previously and reinforce the conclusions originally reported: Ranibizumab should be considered for patients with DME and characteristics similar to those of the cohort in this clinical trial, including vision impairment with DME involving the center of the macula. Copyright © 2011 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
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            Dexamethasone intravitreal implant for treatment of diabetic macular edema in vitrectomized patients.

            Xiao Li, Jean-Lou Cochon, Scott Whitcup … (2011)
            To evaluate the safety and efficacy of Ozurdex (dexamethasone intravitreal implant) 0.7 mg in the treatment of diabetic macular edema in vitrectomized eyes. This was a prospective, multicenter, open-label, 26-week study. Fifty-five patients with treatment-resistant diabetic macular edema and a history of previous pars plana vitrectomy in the study eye received a single intravitreal injection of 0.7-mg dexamethasone intravitreal implant. The primary efficacy outcome measure was the change in central retinal thickness from baseline to Week 26 measured by optical coherence tomography. The mean age of patients was 62 years. The mean duration of diabetic macular edema was 43 months. The mean (95% confidence interval) change from baseline central retinal thickness (403 μm) was -156 μm (-190, -122 μm) at Week 8 (P < 0.001) and -39 μm (-65, -13 μm) at Week 26 (P = 0.004). The mean (95% CI) increase in best-corrected visual acuity from baseline (54.5 letters) was 6.0 letters (3.9, 8.1 letters) at Week 8 (P < 0.001) and 3.0 letters (0.1, 6.0 letters) at Week 26 (P = 0.046). At Week 8, 30.4% of patients had gained ≥10 letters in best-corrected visual acuity. Conjunctival hemorrhage, conjunctival hyperemia, eye pain, and increased intraocular pressure were the most common adverse events. Treatment with dexamethasone intravitreal implant led to statistically and clinically significant improvements in both vision and vascular leakage from diabetic macular edema in difficult-to-treat vitrectomized eyes and had an acceptable safety profile.
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              A phase II randomized clinical trial of intravitreal bevacizumab for diabetic macular edema.

              R Edwards, Melissa C. Greven, Ingrid Scott … (2007)
              To provide data on the short-term effect of intravitreal bevacizumab for diabetic macular edema (DME). Randomized phase II clinical trial. One hundred twenty-one eyes of 121 subjects (109 eligible for analysis) with DME and Snellen acuity equivalent ranging from 20/32 to 20/320. Random assignment to 1 of 5 groups: (A) focal photocoagulation at baseline (n = 19), (B) intravitreal injection of 1.25 mg of bevacizumab at baseline and 6 weeks (n = 22), (C) intravitreal injection of 2.5 mg of bevacizumab at baseline and 6 weeks (n = 24), (D) intravitreal injection of 1.25 mg of bevacizumab at baseline and sham injection at 6 weeks (n = 22), or (E) intravitreal injection of 1.25 mg of bevacizumab at baseline and 6 weeks with photocoagulation at 3 weeks (n = 22). Central subfield thickness (CST) on optical coherence tomography and best-corrected visual acuity (VA) were measured at baseline and after 3, 6, 9, 12, 18, and 24 weeks. At baseline, median CST was 411 mum and median Snellen VA equivalent was 20/50. Compared with group A, groups B and C had a greater reduction in CST at 3 weeks and about 1 line better median VA over 12 weeks. There were no meaningful differences between groups B and C in CST reduction or VA improvement. A CST reduction > 11% (reliability limit) was present at 3 weeks in 36 of 84 (43%) bevacizumab-treated eyes and 5 of 18 (28%) eyes treated with laser alone, and at 6 weeks in 31 of 84 (37%) and 9 of 18 (50%) eyes, respectively. Combining focal photocoagulation with bevacizumab resulted in no apparent short-term benefit or adverse outcomes. Endophthalmitis developed in 1 eye. The following events occurred during the first 24 weeks in subjects treated with bevacizumab without attributing cause to the drug: myocardial infarction (n = 2), congestive heart failure (n = 1), elevated blood pressure (n = 3), and worsened renal function (n = 3). These results demonstrate that intravitreal bevacizumab can reduce DME in some eyes, but the study was not designed to determine whether treatment is beneficial. A phase III trial would be needed for that purpose.
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                Author and article information

                Journal
                Journal ID (publisher-id): OPH
                Journal ID (nlm-ta): Ophthalmologica
                Journal ID (doi): 10.1159/issn.0030-3755
                Title: Ophthalmologica
                Abbreviated Title: Ophthalmologica
                Publisher: S. Karger AG (Basel, Switzerland karger@ 123456karger.com http://www.karger.com )
                ISSN (Print): 0030-3755
                ISSN (Electronic): 1423-0267
                Publication date (Print): April 2016
                Publication date (Electronic): 24 February 2016
                Volume: 235
                Issue: 3
                Pages: 150-156
                Affiliations
                aDepartment of Ophthalmology, The Eagle Eye Clinic, Seongnam, and bDepartment of Ophthalmology, University of Ulsan, College of Medicine, Asan Medical Center, Seoul, South Korea
                Article
                Publisher ID: OPH2016235003150 Other ID: Ophthalmologica 2016;235:150-156
                DOI: 10.1159/000443751
                PubMed ID: 26908130
                SO-VID: 93dcbe65-33bf-4573-9005-4eae52045231
                Copyright © © 2016 S. Karger AG, Basel
                License:

                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 or, in the case of photocopying, direct payment of a specified fee to the Copyright Clearance Center. 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
                Date received : 07 December 2015
                Date accepted : 21 December 2015
                Page count
                Figures: 3, Tables: 1, References: 26, Pages: 7
                Categories
                Subject: Original Paper

                ScienceOpen disciplines: Medicine,General social science
                Keywords: Corticosteroid,Diabetic macular edema,Retinal implant,Small-gauge vitrectomy
                Data availability:
                ScienceOpen disciplines: Medicine, General social science
                Keywords: Corticosteroid, Diabetic macular edema, Retinal implant, Small-gauge vitrectomy

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