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Silvia Soare, Christian Hajjar, Eric Parrat, Pierre Yves Merite, Stephan Pommier, Franck Meyer, Olivier Prost-Magnin, Frederic Matonti, Sebastien Guigou; Multicenter OZurdex Assessment foR diabeTic macular edema :MOZART study. Invest. Ophthalmol. Vis. Sci. 2013;54(15):2387.
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© ARVO (1962-2015); The Authors (2016-present)
To evaluate the efficiency and safety of Ozurdex (intravitreal implant of 0,7mg dexamathasone) in visual impairment due to diabetic macular edema (DME).
This was a retrospective, multicenter, non-comparative study. 69 eyes of 59 patients with DME ( 17% type 1 diabetes mellitus, 83% type 2 diabetes mellitus ) followed for at least 6 months (mean follow-up 9,8 months) were included in 5 French eye clinics (P 1,5 collective). We monitored 2 systemic parameters : blood pressure and glycemic balance. Best-corrected visual acuity (BCVA), central retinal thickness (CRT, Spectralis OCT), intraocular pressure (IOP) and cataract progression are studied at baseline and then at 1, 2, 4 and 6 months.
The mean age of patients was 65 years. Diabete mellitus evolved for 15 years on average. The mean systolic blood pressure was 138 mmHg and the mean HbA1c was 7,2%. 17 patients (24%) were naive to any macular treatment. At baseline the mean CRT was 540 µm; the average CRT decrease was : 188 µm at Month 1 (M1), 235 µm at Month 2 (M2), 117 µm at Month 4 (M4), 77 µm at Month 6 (M6). The initial BCVA letter score was 54,4 letters ETDRS; mean improvement from baseline BCVA was 2,1 letters at M1, 5,4 at M2, 2,4 at M4 and 1,6 at M6. For naive patients this gain was increased : 5,8 letters at M1, 6,7 at M2, 8,7 at M4 and 6,7 at M6. During the follow-up 28% of patients had a BCVA >20/40 (73 letters), for only 6% at the baseline. A gain greater than 15 letters was found in 28% of patients ; a loss greater than 15 letters was found in 6% of patients. The mean rate injections was 1,2 at 6 months with an average of 4,9 months for reinjection. The mean initial PIO was 15 mmHg ; ocular hypertension greater than 25 mmHg, managed by topical treatment, was observed in 7% of patients. 4% of progression of cataract, 1,5% of vitreous hemorrhage and none endophtalmitis were reported.
Dexamethasone has an anatomical and functional effectiveness in the treatment of DME. Outcomes for naive patients suggest that the duration of diabetes mellitus and previous treatments are negative factors of recovery. Side effects are rare and manageable. OZURDEX seems to be a treatment for visual impairment due to DME with a favorable safety profile. Patient follow-up must be adapted to the duration of action of the product with a consultation before M2 to detect any high intraocular pressure and before M4 to detect DME recurrence.
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