Outcomes after a 1-Year Treatment with Ranibizumab for Diabetic Macular Edema in a Clinical Setting.

PURPOSE: The aim of this study was to assess the efficacy and safety of ranibizumab in patients with diabetic macular edema (DME). METHODS: We conducted a retrospective analysis of consecutive patients with vision loss due to DME who were treated with ranibizumab. All patients received a loading dose of 3 monthly injections followed by re-treatments on an as-needed basis. The primary endpoint was the change in best-corrected visual acuity (BCVA) at 12 months. Secondary endpoints were the change in central retinal thickness (CRT) and the number of intravitreal injections (IVI) at 12 months. RESULTS: One hundred and six eyes of 78 patients were included. BCVA changed from 48.3 (20/100) letters at baseline to 59.0 letters (20/63) at 12 months (p < 0.0001; mean gain: +10.7 letters), and 38% of the patients had a final BCVA >70 letters. CRT decreased from 519 µm at baseline to 355 µm at 12 months (p < 0.0001). The threshold of the first quartile of the baseline VA was 40 letters. Patients with a baseline VA >40 letters had a higher final VA of 66 ± 14 letters (20/50) versus 43 ± 18 letters (20/125) for patients with a baseline VA ≤40 letters (p < 0.0001). A mean number of 5.4 (3-10) IVI were administered. CONCLUSION: This study conducted in a clinical setting confirms the results of previous randomized trials. The final BCVA was mainly influenced by the baseline BCVA, which supports the utility of early DME treatment before patients experience a severe vision loss.

Comparison of the Effect of Ranibizumab and Aflibercept on Changes in Macular Choroidal Thickness in Patients Treated for Diabetic Macular Edema.

PURPOSE: The aim of this study was to assess the effect of intravitreal injections (IVI) of ranibizumab and aflibercept on the choroidal thickness (CT) in patients with treatment-naive diabetic macular edema (DME) before and after monthly IVI. Patients and Methods. Prospective monocenter study. Inclusion criteria were treatment-naive DME eyes without concomitant panretinal photocoagulation, associated with a decrease in best-corrected visual acuity ≤75 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) scale. DME was defined by a central retinal thickness ≥300 µm on swept-source OCT (Triton DRI OCT, Topcon Corporation, Itabashi, Japan). Patients received 5 IVI of ranibizumab or aflibercept. The primary endpoint was the change in the central subfield CT (CSCT) between inclusion (M0) and 1 month after the fifth IVI (M5). The secondary endpoint was the CT changes between M0 and M5 in other locations of the macular ETDRS grid. RESULTS: Twenty-four eyes of 24 patients with a mean age of 61.1 years were included. Eleven and 13 patients were, respectively, treated with ranibizumab and aflibercept, and 86.4% had type 2 diabetes. The overall CSCT decreased significantly by -12 µm between M0 and M5 (231.7 µm at M0 and 219.7 µm at M5) (p=0.03). It decreased by -15.2 µm (p=0.02) in the aflibercept group (206.9 µm at M0 and 191.7 µm at M5) and by -7.3 µm (p=0.4) in the ranibizumab group (267.5 µm at M0 and 260.2 µm at M5). The CSCT decreased by -4.9 µm in noninjected contralateral eyes (242.3 µm at M0 and 237.4 µm at M5). CT changes between M0 and M5 in the superior, temporal, inferior, and nasal macular inner ring were significant in the aflibercept group but not in the ranibizumab and control groups. CONCLUSION: In DME patients, the CSCT decreases after 5 IVI of anti-VEGF, especially after aflibercept treatment.

Functional and Anatomical Outcomes in Patients With Serous Retinal Detachment in Diabetic Macular Edema Treated With Ranibizumab.

Purpose: To assess the effect of serous retinal detachment (SRD) on functional and anatomical outcomes in ranibizumab-treated patients with diabetic macular edema (DME). Methods: All consecutive ranibizumab-treated patients with SRD were included in this retrospective study. For each patient with SRD, a patient without SRD with the same baseline best-corrected visual acuity (BCVA) was randomly included for adjustment on their baseline BCVA. All patients with SRD were included in group 1 (G1) and those without SRD in G2. The primary endpoint was the mean change in BCVA between baseline and month 12 (M12). Secondary endpoints were the mean change in central retinal thickness (CRT) between baseline and M12, injection number, and proportion of patients who gained/lost ≥15 letters. Results: Seventy-eight eyes were included, 39 in each group. Baseline BCVA was similar in both groups (45.2 and 45.3 letters). Mean change in BCVA between baseline and M12 was not statistically different: 11 ± 12 letters in G1 and 12 ± 13 letters in G2 (P = 0.78). Baseline CRT was 650 ± 130 µm in G1 and 480 ± 79 µm in G2. Mean change in CRT was -235 ± 170 µm in G1 and -130 ± 96 µm in G2 (P = 0.013). Patients received 5.2 and 5.5 injections in G1 and G2 (P = 0.46). In group 1, 38.5% and 2.6% of patients respectively gained and lost ≥15 letters versus 41% (P = 0.1) and 5.1% (P = 0.1) in G2. Conclusions: Similar BCVA gains were observed regardless of the presence of SRD. The higher visual gain usually observed in DME with SRD could be associated with a lower baseline BCVA.

Adaptive optics imaging of geographic atrophy.

PURPOSE: To report the findings of en face adaptive optics (AO) near infrared (NIR) reflectance fundus flood imaging in eyes with geographic atrophy (GA). METHODS: Observational clinical study of AO NIR fundus imaging was performed in 12 eyes of nine patients with GA, and in seven controls using a flood illumination camera operating at 840 nm, in addition to routine clinical examination. To document short term and midterm changes, AO imaging sessions were repeated in four patients (mean interval between sessions 21 days; median follow up 6 months). RESULTS: As compared with scanning laser ophthalmoscope imaging, AO NIR imaging improved the resolution of the changes affecting the RPE. Multiple hyporeflective clumps were seen within and around GA areas. Time-lapse imaging revealed micrometric-scale details of the emergence and progression of areas of atrophy as well as the complex kinetics of some hyporeflective clumps. Such dynamic changes were observed within as well as outside atrophic areas. CONCLUSIONS: in eyes affected by GA, AO nir imaging allows high resolution documentation of the extent of RPE damage. this also revealed that a complex, dynamic process of redistribution of hyporeflective clumps throughout the posterior pole precedes and accompanies the emergence and progression of atrophy. therefore, these clumps are probably also a biomarker of rpe damage. AO NIR imaging may, therefore, be of interest to detect the earliest stages, to document the retinal pathology and to monitor the progression oF GA. (ClinicalTrials.gov number, NCT01546181.).

Topography of patchy retinal whitening during acute perfused retinal vein occlusion by optical coherence tomography and adaptive optics fundus imaging.

PURPOSE: During perfused retinal vein occlusions, patchy retinal opacification due to acute neuronal swelling may be present. This may be difficult to document using conventional imaging techniques. METHODS: Three-dimensional topography of focal retinal opacification was documented in a patient with hemiretinal vein occlusion by combining en face adaptive optics (AO) imaging with high-resolution optical coherence tomography (OCT). RESULTS: Patchy retinal opacification in the macula was faintly visible by color fundus photography with no angiographic correlation. Adaptive optics and OCT imaging showed that these areas were located in the plexiform layers while the nerve fiber layer remained spared. During follow-up, visual acuity returned to 20/20 with normalization of fundus features and of AO imaging. At last examination, optical coherence tomography showed thinning of the inner nuclear layer in the area previously opacified. CONCLUSIONS: Patchy retinal opacification that may be observed at the acute phase of perfused central retinal vein occlusion corresponds to ischemic opacification of intermediary neurons within the inner nuclear and inner plexiform layers.