Dexamethasone intravitreal implant in treatment-naïve diabetic macular oedema: findings from the prospective, multicentre, AUSSIEDEX study

Abstract

Aim: To evaluate the effectiveness of dexamethasone intravitreal implant 0.7 mg (DEX; Ozurdex) monotherapy in the patient subgroup of the AUSSIEDEX study with treatment-naïve diabetic macular oedema (DME).

Methods: The open-label, prospective, phase 4, real-world study included pseudophakic eyes and phakic eyes scheduled for cataract surgery that were treatment-naïve or non-responsive to antivascular endothelial growth factors. No eyes were excluded based on baseline best-corrected visual acuity (BCVA) or central subfield retinal thickness (CRT). After the initial DEX injection at the baseline visit, reinjection was permitted at ≥16-week intervals. Week-16 and week-52 visits were mandatory. Primary endpoints were changes in mean BCVA and CRT from baseline to 52 weeks.

Results: Of 200 eyes enrolled in the AUSSIEDEX study, 57 were treatment-naïve. Baseline mean BCVA was 58.8 letters and baseline mean CRT was 418.6 µm; changes in mean BCVA and CRT from baseline to 52 weeks in this subgroup were 3.4 letters (p=0.042) and -89.6 µm (p<0.001), respectively, with a mean 2.5 injections. The change in mean CRT from baseline was -55.8 µm at week 16 (p<0.001). The most common adverse event was increased intraocular pressure (IOP), with 20.0% of eyes requiring IOP-lowering medication. One patient was discontinued due to increased IOP. No eyes required filtration surgery. No serious, treatment-related ocular adverse events were reported.

Conclusion: In this largest prospective, real-world study of DEX monotherapy for DME to date, DEX significantly improved CRT and BCVA at 52 weeks in treatment-naïve eyes, without new safety concerns, supporting DEX use in treatment-naïve DME.

Trial registration number: NCT02731911.

Keywords: inflammation; macula; retina; treatment Medical; vision.

Conflict of interest statement

Competing interests: The study was sponsored by Allergan (prior to its acquisition by AbbVie). Financial arrangements of the authors with companies whose products may be related to the present report are listed below, as declared by the authors. SF-B, MD, PhD: Consultant for Allergan (an AbbVie company), Bayer and Novartis. HKK, MD: Scientific advisory member for Allergan (an AbbVie company). PM, MD, PhD: Advisory board member for and honoraria from Allergan (an AbbVie company), Bayer, and Novartis. JJA, MD: Advisory board member for and honoraria from Allergan (an AbbVie company), Alcon, Bayer and Novartis. JT, RN, and SS, BS: Employees of AbbVie.

© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1

Change in mean (SD) (A, C) BCVA and (B, D) CRT from baseline over time in the overall population (A, B) and treatment-naïve patients (C, D). BCVA, best-corrected visual acuity; CRT, central retinal thickness.

Figure 2

Proportion of treatment-naïve patients with a ≥15-letter, ≥10-letter and ≥5-letter gain, no change, or ≥15-letter, ≥10-letter and ≥5-letter loss from baseline at each visit. *No change means a gain or loss of 4 letters or less.