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 mu m at week 52 (mean change -60.9 mu m; 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- naive 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.