Optical Coherence Tomography Predictors of Favorable Functional Response in Naïve Diabetic Macular Edema Eyes Treated with Dexamethasone Implants as a First-Line Agent.

PURPOSE: To evaluate efficacy and safety of intravitreal dexamethasone 0.7 mg implant in treatment-naïve DME patients and to assess the utility of OCT structural biomarkers as predictors of functional response after treatment. METHODS: Thirty-nine eyes of 39 diabetic patients with center involving DME were enrolled. Best-corrected visual acuity (BCVA) and SS-OCT (DRI SS-OCT Triton, Topcon, Japan) to evaluate central retinal thickness (CRT), serous retinal detachment (SRD), intraretinal cysts (IRC), number of hyper-reflective spots (HRS), integrity of the ellipsoid zone (EZ), disorganization of the inner retinal layers (DRIL), vitreomacular adhesion (VMA), vitreomacular traction (VMT), and posterior vitreous detachment (PVD) were evaluated at baseline and at 3, 6, and 12 months after treatment. Multiple logistic analysis was performed to evaluate the possible OCT biomarker as predictive factors for final visual acuity improvement at the end of treatment. RESULTS: At 12 months after treatment, the mean BCVA improved from 51.6 ± 17.5 to 56.9 ± 17.3 ETDRS letters (p=0.03). Furthermore, there were statistically significant changes in CRT, IRC, HRS, and SRD. Nineteen patients presented a >10-letters improvement in BCVA; the presence of SRD at baseline was a predictor of good functional treatment response at 12 months (OR 2.1; 95% C.I. 1.2-4.9; p=0.001) as well as the presence of EZ integrity preoperatively (OR 1.3; 95% C.I. 0.5-2.4; p=0.001) and the absence of vitreoretinal interface alteration (OR 1.1; 95% C.I. 0.3-2.3; p=0.02). No significant changes in the IOP and lens status were observed throughout the follow-up period. CONCLUSION: This study empathized the importance of structural biomarkers as predictors of favorable response and confirmed the efficacy and safety of intravitreal dexamethasone implant in treatment-naïve DME patients showing a better functional response in the presence of SRD integrity of EZ and absence of vitreoretinal alterations.

Foveal avascular zone analysis by optical coherence tomography angiography in patients with type 1 and 2 diabetes and without clinical signs of diabetic retinopathy.

PURPOSE: To analyze the early macular microvascular alterations in patients with type 1 and 2 diabetes mellitus (DM) without diabetic retinopathy (DR), using optical coherence tomography angiography (OCT-A), and compare these with nondiabetic patients. METHODS: This prospective study involved 93 patients with type 1 diabetes (DM1), 104 patients with type 2 diabetes (DM2) without signs of DR, and 71 healthy subjects for the control group. The foveal avascular zone (FAZ) area and the vessel density (VD) at the superficial capillary plexus (SCP) and deep capillary plexus (DCP) were evaluated. RESULTS: The SCP and DCP FAZ areas were significantly larger in the DM1 group in comparison with the controls (p = .001), while no significant differences were observed between the DM2 group and the healthy control group (p = .12). Additionally, no significant differences in FAZ area were found between the DM1 and DM2 groups (p = .26). The VD was significantly reduced in DM1 and DM2 groups compared to controls. A direct correlation was found between the duration of diabetes and SCP FAZ area (r = 0.44; R2 = 0.19; p = .0001). Statistically significant differences in the FAZ area at SCP and DCP were observed when comparing patients with a diabetes duration > 10 years and < 10 years in the DM2 group (p = .0001, respectively) and only in the FAZ area at the DCP in the DM1 group (p = .0001). CONCLUSION: Diabetic patients without DR demonstrate early microvascular alteration in the macular area on OCT-A, which is more pronounced in type I DM, and correlates with the duration of the disease.

The Application of Structural Retinal Biomarkers to Evaluate the Effect of Intravitreal Ranibizumab and Dexamethasone Intravitreal Implant on Treatment of Diabetic Macular Edema.

BACKGROUND: The aim of this study was to compare the therapeutic effect of intravitreal treatment with ranibizumab and dexamethasone using specific swept-source optical coherence tomography retinal biomarkers in patients with diabetic macular edema (DME). METHODS: 156 treatment-naïve patients with DME were divided in two groups: 75 patients received 3 monthly intravitreal injections of ranibizumab 0.5 mg (Lucentis®) (Group 1) and 81 patients received an intravitreal implant of dexamethasone 0.7 mg (Ozurdex®) (Group 2). Patients were evaluated at baseline (V1), at three months post-treatment in Group 1, and at two months post-treatment in Group 2 (V2). Best-corrected visual acuity (BCVA) and swept source-OCT were recorded at each interval. Changes between V1 and V2 were analyzed using the Wilcoxon test and differences between the two groups of treatment were assessed using the Mann-Whitney test. Multiple regression analysis was performed to evaluate the possible OCT biomarker (CRT, ICR, CT, SND, HRS) as predictive factors for final visual acuity improvement. RESULTS: In both groups, BCVA improved (p-value < 0.0001), and a significant reduction in central retinal thickness, intra-retinal cysts, red dots, hyper-reflective spots (HRS), and serous detachment of neuro-epithelium (SDN) was observed. A superiority of dexamethasone over ranibizumab in reducing the SDN height (p-value = 0.03) and HRS (p-value = 0.01) was documented. CONCLUSIONS: Ranibizumab and dexamethasone are effective in the treatment of DME, as demonstrated by functional improvement and morphological biomarker change. DME associated with SDN and HRS represents a specific inflammatory pattern for which dexamethasone appears to be more effective.

A randomized trial of intravitreal bevacizumab vs. ranibizumab for myopic CNV.

AIMS: The aim was to compare the efficacy of intravitreal therapy with bevacizumab and ranibizumab for choroidal neovascularization (CNV) in pathologic myopia (PM). METHODS: This was a prospective multicenter randomized nonblinded trial. RESULTS: In seven centers, 78 eyes were randomized 1:1 to treatment with bevacizumab (group B, 40 eyes) or ranibizumab (group R, 38 eyes) given with an "on demand" regimen (PRN). The mean follow-up was 19 months (SD 2, range 12-24). The mean BCVA at baseline was 0.60 logMAR (20/80 Snellen equivalent, Seq) and 50 letter score (ls). Mean final BCVA was 0.51 LogMAR (20/63 Seq) and 57 ls (p = 0.0009 and p = 0.0002, respectively). In group B, mean basal BCVA was 0.52 logMAR (20/63 Seq) and 54 ls, and final BCVA was 0.51 logMar (20/63 Seq) and 57 ls. In group R, mean basal BCVA was 0.62 logMAR (20/80 Seq) and 45 ls, and the final values were 0.50 logMAR (20/63 Seq) and 58 ls. Statistical comparison of the two groups showed no significant difference (logMAR p = 0.90 and letters p = 0.78). Multivariate analysis showed no influence of age or previous photodynamic treatment (PDT) on final visual changes. The mean number of treatments in the first year was 2.7 in group B and 2.3 in group R (p = 0.09). CONCLUSION: Myopic CNV equally benefits from on-demand intravitreal injection of either bevacizumab or ranibizumab; the therapeutic effect is independent of previous PDT and age.

Hyperhomocysteinemia and retinal vascular changes in patients with epilepsy.

The possible occurrence of asymptomatic retinal vascular damage was investigated in 87 hyperhomocysteinemic (plasma total homocysteine >13micromol/L) adult epileptic patients (46 M, 41 F; age 34.2+/-7.5 years; mean plasma homocysteine levels 29.8+/-15.4micromol/L; duration of epilepsy 11.5+/-2.4 years) with no other risk factors for atherosclerosis. Plasma total homocysteine (t-Hcy) levels were assayed by high performance liquid chromatography. Retina vascular status was assessed by fundus oculi ophthalmoscopy performed in blind conditions by two skilled ophthalmologists and compared with that obtained from 102 randomly chosen epileptic patients and 94 healthy subjects, matched for age and sex, showing normal t-Hcy levels. No retina abnormality was detected in any of the subjects belonging to the three groups. Based on these results, we conclude that epileptic patients with mild to intermediate hyperhomocysteinemia are not at risk to develop retinal vascular disease.