A Collaborative Retrospective sTudy on the Efficacy and Safety of intravitreal dexamethasone implant (Ozurdex) in patients with Diabetic Macular Edema (DME). THE EUROPEAN DME REGISTRAR STUDY (ARTES)

ABSTRACT Purpose To evaluate the efficacy, effect profile and safety of dexamethasone implant on diabetic macular edema (DME) in a real-life setting, comparing early ( Design A multicentral retrospective cohort of 340 DME eyes/287 patients from 25 EVICR.net clinical sites from 8 countries. Methods Data was analyzed in two perspectives; “Per-injection”- all measurements were grouped, baseline was defined as the day of injection, thus the pharmacodynamics of single injections could be assessed. “Injection series” defined as ≥2 injections with 3-6 months between injections, outcome was measured 3-6 months after the last injection. Main Outcome Measures Primary outcome was improvement of ≥15-letter in best corrected visual acuity (BCVA) from baseline. Secondary outcomes included improvement of ≥10-letters, change in central macular thickness (CMT), time to maximal improvement and safety. Results Overall, 762 injections were given to 340 eyes of 287 patients. Injection series analysis included 171 series in 171 eyes/150 patients, for a total of 444 injections, with a mean follow-up of 1.7±0.8 years. Of the 762 injections analysed per-injection, 22.7% achieved ≥15-letter and 37.8% ≥10 letters improvement. Mean time to peak improvement was 81.9±39.7 days. Mean maximal change in CMT was -174±171μm. Overall 7.6% lost ≥15 letters. More eyes with early DME gained ≥10 letters and less lost ≥10 letters compared to late DME (47.4% vs 33.9% p=0.001, 8.2% vs 13.4% p=0.029 respectively). Patients with controlled diabetes had greater CMT reduction (p=0.0002). A higher percentage of naive patients gained BCVA ≥10/15-letter improvement (p=0.003, 0.006, respectively). Injection series’ patients received 2.60±1.0 injections per-series, 20.5% achieved ≥15-letter and 35.7% ≥10 letters improvement. Only 7.0% lost ≥15 letters. Time to peak improvement from first injection was 350±156 days. Naive patients had greater BCVA ≥10/15-letter improvement (p=0.003). Intraocular pressure elevation >25 mmHg was found in 7.9% eyes, no eye underwent trabeculectomy, 12.4% had cataract surgery and no endophthalmitis was reported. Conclusions Dexamethasone implant is an effective and safe treatment for DME. Peak improvement was achieved 3 months post-injection and dissipated thereafter. Clinicians and providers may consider shortening treatment intervals.