Rapid Structural and Functional Improvements with the 0.19 mg Fluocinolone Acetonide Intravitreal Implant for Patients with DME and Low Visual Acuity: 6-Month Data from the UAE
Authors Elbarky AM
Received 15 November 2019
Accepted for publication 28 January 2020
Published 16 March 2020 Volume 2020:14 Pages 823—830
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr Scott Fraser
Ahmed Mohammed Elbarky1,2
1Vitreoretinal consultant, Sheikh Khalifa Medical City, Abu Dhabi, United Arab Emirates; 2Department of Ophthalmology, Benha Faculty of Medicine, Benha University, Benha, Egypt
Correspondence: Ahmed Mohammed Elbarky Email firstname.lastname@example.org
Purpose: The 0.19 mg fluocinolone acetonide (FAc) intravitreal implant is approved in the United Arab Emirates (UAE) for treating diabetic macular edema (DME) in patients previously treated with a course of corticosteroids and that did not have a clinically significant rise in intraocular pressure (IOP). This ongoing study is assessing its effectiveness and safety in pseudophakic patients with DME in clinical practice from a single center in the UAE.
Methods: A retrospective, ongoing 6-month audit study (NCT03590587), in which 22 eyes from 22 patients were treated with a single FAc intravitreal implant after treatment with a prior course of corticosteroids. Outcomes assessed included mean changes in best-corrected visual acuity (BCVA), central macular thickness (CMT), and IOP. Six-month follow-up data are presented.
Results: After FAc implantation, mean BCVA improved rapidly, increasing by 25.4 ± 3.0 letters (mean±SEM) from baseline to Month 6 (p< 0.0001). At 6 months, BCVA had improved by 15 letters or more in 91% of eyes (n=20/22). Mean CMT decreased by 267.0 ± 20.1 μm from baseline to Month 6 (p< 0.0001). Over 85% of eyes (n=19/22) had a CMT less than 300 μm at 6 months. Mean IOP increased by 2.9 ± 0.7 mmHg from baseline to Month 6 (p< 0.001). All eyes except 2 had an IOP of 21 mmHg or lower. At Month 6, five eyes (23%) needed IOP-lowering therapy.
Conclusion: Injection of the FAc intravitreal implant rapidly and significantly improved BCVA and CMT within 6 months. These rapid and significant improvements exceed those reported in other real-world studies. Safety signals were consistent with corticosteroid class effects. The FAc implant may be a useful treatment option for patients in the UAE, particularly those with sight threatening DME requiring rapid functional improvements.
Keywords: diabetic macular edema, fluocinolone acetonide intravitreal implant, clinical evidence
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. 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.Download Article [PDF] View Full Text [HTML][Machine readable]