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The International Retina Group Real-Life 24-Month Multicenter Study. The IRGREL-DEX Study

Iglicki, Matias, MD*; Busch, Catharina, MD; Zur, Dinah, MD‡,§; Okada, Mali, Mmed; Mariussi, Miriana, MD**; Chhablani, Jay Kumar, MD††; Cebeci, Zafer, MD‡‡; Fraser-Bell, Samantha, Bsc(Med), MBBS, MHA, MPH, PhD, FRANZCO§§; Chaikitmongkol, Voraporn, MD¶¶; Couturier, Aude, MD***; Giancipoli, Ermete, MD†††; Lupidi, Marco, MD‡‡‡; Rodríguez-Valdés, Patricio J., MD§§§; Rehak, Matus, MD; Fung, Adrian Tien-chin, MBBS, MMed(ClinEpi), MMed(OphthalSci), FRANZCO¶¶¶,****,††††; Goldstein, Michaella, MD‡,§; Loewenstein, Anat, MD‡,§,††††

doi: 10.1097/IAE.0000000000002196
Original Study

Purpose: To investigate efficacy and safety of repeated dexamethasone (DEX) implants over 24 months, in diabetic macular edema (DME) eyes that were treatment naive compared with eyes refractory to anti-vascular endothelial growth factor treatment, in a real-life environment.

Methods: This multicenter international retrospective study assessed best-corrected visual acuity and central subfield thickness (CST) of naive and refractory eyes to anti-vascular endothelial growth factor injections treated with dexamethasone implants. Safety data (intraocular pressure rise and cataract surgery) were recorded.

Results: A total of 130 eyes from 125 patients were included. Baseline best-corrected visual acuity and CST were similar for naive (n = 71) and refractory eyes (n = 59). Both groups improved significantly in vision after 24 months (P < 0.001). However, naive eyes gained statistically significantly more vision than refractory eyes (+11.3 ± 10.0 vs. 7.3 ± 2.7 letters, P = 0.01) and were more likely to gain ≥10 letters (OR 3.31, 95% CI 1.19–9.24, P = 0.02). At 6, 12, and 24 months, CST was significantly decreased compared with baseline in both naive and refractory eyes; however, CST was higher in refractory eyes than in naive eyes (CST 279 ± 61 vs. 313 ± 125 μm, P = 0.10).

Conclusion: Over a follow-up of 24 months, vision improved in diabetic macular edema eyes after treatment with dexamethasone implants, both in eyes that were treatment naive and eyes refractory to anti-vascular endothelial growth factor treatment; however, improvement was greater in naive eyes.

Visual and anatomical indicators improved in eyes with diabetic macular edema after treatment with dexamethasone implants, both in eyes that were treatment naive and eyes refractory to previous anti-vascular endothelial growth factor treatment. However, improvement was statistically significantly greater in naive eyes.

*Private Retina Office, University of Buenos Aires, Argentina;

Department of Ophthalmology, University of Leipzig, Germany;

Division of Ophthalmology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel;

§Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel;

Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia;

**Favaloro University Hospital, Buenos Aires, Argentina;

††L. V. Prasad Eye Institute, Banjara Hills, Hyderabad, India;

‡‡Department of Ophthalmology, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey;

§§Department of Ophthalmology, Save Sight Institute, University of Sydney, Sydney, New South Wales, Australia;

¶¶Retina Division, Department of Ophthalmology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand;

***Service d'Ophtalmologie, Hôpital Lariboisière, AP-HP, Université Paris 7—Sorbonne Paris Cité, Paris, France;

†††Department of Ophthalmology, Azienda Ospedaliero Universitaria Sassari, Sassari, Italy;

‡‡‡Department of Biomedical and Surgical Sciences, Section of Ophthalmology, University of Perugia, Perugia, Italy;

§§§Servicio de Retina, Centro Medico Zambrano Hellion, Tecnológico de Monterrey, San Pedro Garza García, Nuevo Leon, Mexico;

¶¶¶Faculty of Medicine and Health Sciences, Macquarie University, Sydney, Australia;

****Save Sight Institute, University of Sydney, Sydney, Australia;

††††Westmead Hospital, Sydney, Australia; and

‡‡‡‡Incumbent, Sydney A. Fox Chair in Ophthalmology, Tel Aviv University, Tel Aviv, Israel.

Reprint requests: Matias Iglicki, MD, Retina Private Office, University of Buenos Aires, 525 Aguirre Street, 3rd floor, Apartment A, Buenos Aires, Argentina 1414; e-mail:

The International Retina Group is an independent research branch of the International Retina Panel, which receives travel support from Allergan.

Anat Loewenstein—Consultant for Allergan. Matias Iglicki and Catharina Busch contributed equally to this paper.

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© 2019 by Ophthalmic Communications Society, Inc.