Abstract
Purpose :
Dexamethasone (DEX) 0.7 mg implant (Ozurdex®) is the most recently approved corticosteroid for the treatment of diabetic macular edema (DME) and it strongly decreases retinal thickness in DME. We performed a retrospective, observational clinical study to evaluate the efficacy of Ozurdex on refractory and naïve DME.
Methods :
Patients with fovea-involving DME with follow-up of at least 3 months after Ozurdex injection who had medical records of best-corrected visual acuity (BCVA), central macular thickness (CMT) measured by spectral domain optical coherence tomography (SD-OCT) (Spectralis; Heidelberg Engineering, Germany) were included. We considered 3 months because the therapeutic effect of Ozurdex was maintained up to 3 months in all cases and repeated injections were performed after 3 months, if needed. The efficacy was evaluated by comparing BCVA and CMT between baseline and 3 months after each injections. Paired sample t-test and Wilcoxon signed-rank test was used to compare the mean differences with P value < 0.05 considered statistically significant using the SPSS software (version 17.0; SPSS Inc, Chicago, IL).
Results :
A total of 48 injections were performed in 35 eyes of 23 patients (mean age 62 ± 14 years). 13 eyes were treatment naïve and 22 eyes had refractory DME with previous intravitreal anti-VEGF injections (mean 3.6 ± 2.6 times). Mean BCVA was 0.55 ± 0.41 LogMAR at baseline and it improved to 0.43 ± 0.34 LogMAR at 3 months (P=0.002). Mean CMT decreased to 266 ± 99 µm at 3 months from 513 ± 202 µm at baseline (P=0.000). 5 eyes showed reduced response to Ozurdex treatment (2 naïve, 3 refractory eyes); mean BCVA at baseline and 3 months was 0.23 ± 0.18 LogMAR and 0.24 ± 0.18 LogMAR (P=0.257), mean CMT at baseline and 3 months was 551 ± 90 µm and 431 ± 108 µm (P=0.012). All 5 eyes had subfoveal cystoid spaces on OCT which were persistent after Ozurdex treatment. Cataract extraction was performed in 3 of 18 phakic eyes (16.7%) and transient intraocular pressure rise was seen in 5 eyes (14.3%).
Conclusions :
Intravitreal DEX implant has functional and anatomical benefits in refractory and naïve DME cases with manageable side effects. However, its efficacy may be reduced in DME with subfoveal cystoid spaces. Further studies are needed to better understand this relationship but OCT may be helpful in predicting the therapeutic response and counseling patients with DME.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.