Dexamethasone intravitreal implant in diabetic macular oedema refractory to anti-vascular endothelial growth factors: the AUSSIEDEX study.

Aim: To evaluate effectiveness of dexamethasone intravitreal implant 0.7 mg (DEX) monotherapy in the AUSSIEDEX study non-responder subgroup, defined by diabetic macular oedema (DME) refractory to anti-vascular endothelial growth factor (anti-VEGF) agents.
Methods: This prospective, open-label, observational, real-world study included pseudophakic and phakic (scheduled for cataract surgery) eyes that did not achieve a ≥5-letter best corrected visual acuity (BCVA) gain and/or clinically significant central subfield retinal thickness (CRT) improvement after 3-6 anti-VEGF injections for DME (N=143 eyes), regardless of baseline BCVA and CRT. After an initial DEX injection (baseline visit), reinjection was permitted at ≥16-week intervals.
Primary Endpoints: changes in mean BCVA and CRT from baseline to week 52. Safety assessments included adverse events.
Results: Of 143 eyes, 53 (37.1%) and 89 (62.2%) switched to DEX after 3-6 (early) and >6 (late) anti-VEGF injections, respectively; 1 (0.7%) had missing information. With 2.3 injections (mean) over 52 weeks, the change in mean BCVA from a baseline of 57.8 letters was not significant at week 52. Mean CRT improved significantly from a baseline of 417.8 μm at week 52 (mean change -60.9 μm; p<0.001). Outcomes were similar in eyes switched to DEX early and late. No unexpected adverse events were reported; no filtration surgeries were required.
Conclusion: To date, AUSSIEDEX is the largest prospective, real-world study of DEX monotherapy for treatment-naïve or anti-VEGF-refractory DME. Following early or late switch from anti-VEGF agents, DEX significantly improved anatomic outcomes at 52 weeks without new safety concerns, supporting use in anti-VEGF-refractory DME.
Trial Registration Number: NCT02731911.
Competing Interests: Competing interests: Financial arrangements of the authors with companies whose products may be related to the present report are listed below, as declared by the authors. PM, MD, PhD: Advisory board member for and honoraria from Allergan (an AbbVie company), Bayer, and Novartis. JA, MD: Advisory board member for and honoraria from Alcon, Allergan (an AbbVie company), Apellis, Bayer, Novartis, and Roche. SF-B, MD, PhD: Consultant for Allergan (an AbbVie company), Bayer, Novartis, and Roche. HKK, MD: Scientific advisory member for Allergan (an AbbVie company). AAC, MD, PhD: Advisor for Alcon, Allergan (an AbbVie company), Apellis, Bayer, Novartis, and Roche. JT, RN: Employee of Allergan (an AbbVie company) at the time the study was conducted, and current employee of Pfizer. SS, BS, RN: Employee of Allergan (an AbbVie company) at the time the study was conducted.
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