Session Title: FP-14 Vascular Diseases and Diabetic Retinopathy IV
Session Date/Time: Saturday 13/09/2014 | 16:30-18:00
Paper Time: 17:34
Venue: Boulevard F
First Author: : P.Monaco ITALY
Co Author(s): : L. Tollot M. Del Borrello A. Frattolillo F. Sperti M.V. Cigada
To compare the functional and structural effects of intravitreal ranibizumab (IVR) versus subthreshold micropulse diode laser (SMDL) in patients with clinically significant diabetic macular edema.
Between January 2012 and May 2013 24 diabetic patients with visual impairment due to diabetic macular edema (DME) were followed in our ophthalmology department and enrolled in a retrospective interventional study. Glycosylated hemoglobin (HbA1c) > 11.0 %, previous treatments, planned surgery or ischemic DME were exclusion criteria.
In 2012 October, the National Institute for Health and Clinical Excellence (NICE) approved intravitreal Ranibizumab in patients with diabetic macular edema (DME) and mean foveal thickness (MFT) >400 µm. 32 eyes of 24 consecutive patients with clinically significant diabetic macular edema were retrospectively reviewed and treated with intravitreal ranibizumab or micropulse diode laser depending on whether the mean foveal thickness was ≥ or < 400 µm respectively. Each patient underwent best-corrected visual acuity (BCVA) measurement (expressed in logMAR using ETDRS charts), complete eye examination including digital dynamic fluorescein angiography and mean foveal thickness (MFT) using spectral-domain optical coherence tomography (Heidelberg Engineering) were recorded at baseline, 3, 6 and 9-month. 16 eyes (IVR group) received 3 monthly ranibizumab injections (0.5 mg/0.05 ml). 16 eyes (SMDL group) were treated with 810-nm subthreshold micropulse diode laser (Iridex Oculite SLx, Iridex Corp.) using the same parameters for all treatments (5% duty, 920 mW). Confluent treatment of thickened areas avoiding the fovea was performed. 4 patients underwent a single session of SMDL according to the same therapeutic protocol during the follow-up period.
The different treatment groups were compared with multiple regression analysis using baseline OCT and BCVA as a covariate (both showing statistical significance, P<0.0007 and P<0.0000009, respectively). Ranibizumab treated subjects gained 4.0 letters vs. 0.9 letters lost for subthreshold micropulse diode laser, but there was no significant difference between the 2 treatment groups (P=0.69). MFT decreased in both groups (mean change -32,7 µm in SMDL group, -140,9 µm in IVR group). These changes in MFT from baseline were not statistically significant (P=0.21). Ranibizumab monotherapy was not associated with an increased risk of cardiovascular, cerebrovascular events or endophthalmitis cases in this study.
In our study ranibizumab therapy seems to be more effective in visual acuity gain and retinal thickness reduction over subthreshold micropulse diode laser in patients with visual impairment due to DME.