ObjectiveTo observe alterations of macular outer retinal reflectivity (ORR) and the associations with macular vessel density in patients with nonproliferative diabetic retinopathy (NPDR). Methods A retrospective cross-sectional study. From August 2021 to March 2022, a total of 63 NPDR patients with 63 eyes (NPDR group) diagnosed by Department of Ophthalmology of Guangdong Provincial People's Hospital were included in the study. There were 39 males with 39 eyes and 24 females with 24 eyes. Age was 60 (52, 68) years. A total of 66 eyes of 66 healthy volunteers matching age and sex were selected as the control group. Among them, 40 men had 40 eyes and 26 women had 26 eyes. Age was 58 (52, 67) years. Optical coherence tomography (OCT) and OCT angiography (OCTA) were performed in all affected eyes. Image J software was used to calculate ORR, including the optical density of ellipsoid zone (EZ), photoreceptor outer segment (OS), photoreceptor inner segment (IS) and outer nuclear layer (ONL) by OCT examination. The sampling sites were horizontal and vertical scanning of the fovea of the macula on 500 μm (nasal500, temporal500, superior500, inferior500), 1 000 μm (nasal1 000, temporal1 000, superior1 000, inferior1 000) and 2 000 μm (nasal2 000, temporal2 000, superior2 000, inferior2 000). The software automatically divided the retina within 6 mm of the macular fovea into the fovea with a diameter of 1 mm, the parafovea with a diameter of 1-3 mm, and the perifovea with a diameter of 3-6 mm by macular OCTA examination. The blood density of superficial capillary plexus and deep capillary plexus in different zones in the macular area were measured by the built-in software of the device. Spearman correlation analysis was used to analyze the correlation between ORR and blood flow density. ResultsCompared with the control group, retinal reflectivity of EZ in NPDR group was significantly decreased at other sites except the fovea, retinal reflectivity of OS was significantly decreased at nasal2 000, temporal2 000, superior2 000 and superior1 000; retinal reflectivity of IS was significantly decreased at superior1 000, superior500 and inferior500. The retinal reflectivity of ONL in macular fovea was significantly decreased, and the differences were statistically significant (P＜0.05). The ORR was positively correlated with blood flow density, and the correlation coefficient in NPDR group was lower than that in control group. The results of multifactor linear regression analysis showed that the superior and temporal ORR were correlated with blood flow density (P＜0.05). ConclusionsCompared with the control group, ORR is reduced and less correlated with vessel density in NPDR patients. ORR is more affected by retinal blood flow density in temporal and superior parts.
ObjectiveTo assess the efficacy and safety of intravitreal aflibercept injection (IAI) compared with photodynamic therapy (PDT) in the treatment of Chinese patients with predominantly classic subfoveal choroidal neovascularization (CNV) lesions secondary to neovascular age-related macular degeneration (nAMD).MethodsA randomized, double-blind, multi-center phase-3 clinical trial lasting for 52 weeks (from December 2011 to August 2014). Subjects were randomized in a 3:1 ratio to either IAI group or PDT-to-IAI group. Subjects in the IAI group received 2 mg IAI at baseline and at week 4, 8, 16, 24, 32, 40, 48, with sham injection at week 28, 36. Subjects in the PDT-to-IAI group were forced to receive PDT once at baseline and more time at week 12, 24 if PDT retreatment conditions were met. Sham injections were given in PDT-to-IAI group at baseline and at week 4, 8, 16 and 24, followed by 2 mg IAI at week 28, 32, 36, 40, 48. The primary outcome of efficacy were the change in mean Best Corrected Visual Acuity (BCVA) from baseline to week 28, and that of week 52. Safety evaluation included the percentage of subjects who suffered treatment emergent adverse events (TEAEs).ResultsAmong the 304 subjects enrolled, there were 228 and 76 cases in IAI group and PDT-to-IAI group respectively. At week 28, the changes of mean BCVA in IAI group, PDT-to-IAI group compared to baseline were +14.0, +3.9 letters, respectively. At week 52, the changes of mean BCVA in two groups were +15.2, +8.9 letters respectively with the difference of +6.2 letters (95%CI 2.6−9.9, P=0.000 9). At week 52, the mean foveal retinal thickness in the two groups decreased by −189.6, −170.0 μm, respectively. Subjects with the most BCVA increase in IAI group were those aged ＜65, and those with active CNV lesion area ＜50% of total lesion area. The most common TEAEs in IAI group and PDT-to-IAI group are macular fibrosis [11.8% (27/228), 6.6% (5/76)] and BCVA decline [6.6% (15/228), 21.1% (16/76)]. There were 3 cases of arterial thromboembolic events defined in the antiplatelet experimental collaboration group, but all were considered unrelated to interventions.ConclusionsThe efficacy of aflibercept is superior to that of PDT in nAMD patients in China. The therapeutic effect of aflibercept persisted to week 52 in all subjects. The rate of adverse events was consistent with the safety data of aflibercept known before.