Multicenter OZurdex long term assessment for diabetic macular edema: MOZART 2 study

Purpose To evaluate the long-term efficacy and safety of intravitreal implant of 0,7mg dexamathasone (ozurdex®) in diabetic macular edema(DME) Methods This was a retrospective, multicenter, study. 19 patients, with mean age of 67years, followed for at least 8 months (mean 10,7 months) were included in 5 French eye clinics (P1,5 network). The mean systolic blood pressure was 138 mmHg and the mean HbA1c was 7,2%. We monitored 2 systemic parameters: blood pressure and glycemic balance. Best-corrected visual acuity (BCVA), central retinal thickness by spectralis OCT, intraocular pressure and cataract progression are studied at baseline and then at 1, 6 and 12 Months. Results Visual acuity significantly increased compared to baseline: at M1, M6 and M12, mean value of 8,7, 9,1 and 5,8 ETDRSletters, respectively. The improvement was ≥ 10 ETDRS letters in 46,7%, 57,9% and 58,3% of patients at M1, M6 and M12, respectively. The average CRT decrease was: 332μm at M1, 259μm at M6 and 296μm at M12. The average interval between two injections was of 5.6months. Ocular hypertension greater than 25 mmHg, managed by topical treatment, was observed in 13,4% of patients. None glaucoma surgery was necessary Conclusion Ozurdex® has an anatomical and functional effectiveness in the treatment of DME. Outcomes for naive patients and lower CRT suggest that the duration of diabetes mellitus and previous treatments are negative factors for recovery. Side effects are rare and manageable. Ozurdex® seems to be an effective treatment for visual impairment due to DME with a favorable safety profile. Patient follow-up must be adapted to half-life of the product with a control before M1 (intraocular pressure) and before M5 (DME recurrence) Commercial interest