Challenges in Diabetic Macular Edema Management: An Expert Consensus Report

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Abstract

Purpose

This paper aimed to present daily-practice recommendations for the management of diabetic macular edema (DME) patients based on available scientific evidence and the clinical experience of the consensus panel.

Methods

A group of Spanish retina experts agreed to discuss different aspects related with the clinical management of DME patients.

Results

Panel was mainly focused on therapeutic objectives in DME management; definition terms; and role of biomarkers as prognostic and predictive factors to intravitreal treatment response. The panel recommends to start DME treatment as soon as possible in those eyes with a visual acuity less than 20/25 (always according to the retina unit capacity). Naïve patient was defined, in a strict manner, as a patient who, up to that moment, had never received any treatment. A refractory DME patient may be defined as the one who did not achieve a complete resolution of the disease, regardless of the treatment administered. Different optical coherence tomography biomarkers, such as disorganization of the retinal inner layers, hyperreflective dots, and cysts, have been identified as prognostic factors.

Conclusion

This document has sought to lay down a set of recommendations and to identify key issues that may be useful for the daily management of DME patients.

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Most cited references 108

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IDF Diabetes Atlas: Global estimates of diabetes prevalence for 2017 and projections for 2045

J.D. da Rocha Fernandes, Y. Huang, J.E. Shaw … (2018)

Since the year 2000, IDF has been measuring the prevalence of diabetes nationally, regionally and globally.

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Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema.

John A Wells, Adam R Glassman, Allison R Ayala … (2015)

The relative efficacy and safety of intravitreous aflibercept, bevacizumab, and ranibizumab in the treatment of diabetic macular edema are unknown.

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Ranibizumab for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE.

Quan Nguyen, David M Brown, Dennis M Marcus … (2012)

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

Journal ID (nlm-ta): Clin Ophthalmol

Journal ID (iso-abbrev): Clin Ophthalmol

Journal ID (publisher-id): opth

Journal ID (pmc): clinop

Title: Clinical Ophthalmology (Auckland, N.Z.)

Publisher: Dove

ISSN (Print): 1177-5467

ISSN (Electronic): 1177-5483

Publication date (Electronic): 27 July 2021

Publication date Collection: 2021

Volume: 15

Pages: 3183-3195

Affiliations

[1 ]Department of Ophthalmology, Hospital Universitario y Politecnico la FE , Valencia, Spain

[2 ]Department of Ophthalmology, Hospital Clinic Barcelona , Barcelona, Spain

[3 ]Department of Ophthalmology, University Complex Bellvitge , Barcelona, Spain

[4 ]Department of Ophthalmology, Hospital Universitario Lozano Blesa , Zaragoza, Spain

[5 ]Department of Ophthalmology, Hospital Universitario Insular , Las Palmas de Gran Canaria, Spain

[6 ]Department of Ophthalmology, Hospital General Universitario , Valencia, Spain

[7 ]Department of Ophthalmology, Hospital Clínico San Carlos , Madrid, Spain

[8 ]Department of Ophthalmology, Clínica Universitaria de Navarra , Pamplona, Spain

[9 ]Department of Ophthalmology, Hospital Punta Europa , Algeciras, Cádiz, Spain

[10 ]Department of Ophthalmology, Hospital Virgen del Rocío , Sevilla, Spain

[11 ]Department of Ophthalmology, Hospital Puerta de Hierro , Majadahonda, Madrid, Spain

Author notes

Correspondence: Patricia Udaondo Aiken Prevención y Cirugía ocular , Pizarro, 15 Bajo, Valencia, 46004, SpainTel +34647869228 Email draudaondo@gmail.com

Author information

Patricia Udaondo http://orcid.org/0000-0002-5241-0066

Alfredo Adan http://orcid.org/0000-0001-8923-2200

Luis Arias-Barquet http://orcid.org/0000-0001-7041-5576

Francisco Cabrera-López http://orcid.org/0000-0002-5074-5102

Francisco Javier Lavid http://orcid.org/0000-0003-4229-8565

Article

Publisher ID: 320948

DOI: 10.2147/OPTH.S320948

PMC ID: 8327476

PubMed ID: 34349495

SO-VID: c1d7f105-9002-40a3-87f5-2fdce52593bf

License:

This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

History

Date received : 25 May 2021

Date accepted : 23 June 2021

Page count

Figures: 2, Tables: 3, References: 109, Pages: 13

Funding

Funded by: Allergan, an AbbVie company;

Logistic for writing services has been provided by Allergan, an AbbVie company. Allergan did not participate in either data analysis or redaction of the manuscript.

Challenges in Diabetic Macular Edema Management: An Expert Consensus Report

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Conclusion

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Karger: Ophthalmology

Most cited references 108

IDF Diabetes Atlas: Global estimates of diabetes prevalence for 2017 and projections for 2045

Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema.

Ranibizumab for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE.

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