Efficacy and Safety of Biosimilar QL1207 vs. the Reference Aflibercept for Patients with Neovascular Age-Related Macular Degeneration: A Randomized Phase 3 Trial.

INTRODUCTION: This trial aimed to compare the efficacy and safety between biosimilar QL1207 and the reference aflibercept for the treatment of neovascular age-related macular degeneration (nAMD). METHODS: This randomized, double-blind, phase 3 trial was conducted at 35 centers in China. Patients aged ≥ 50 years old with untreated subfoveal choroidal neovascularization secondary to nAMD and best-corrected visual acuity (BCVA) letter score of 73-34 were eligible. Patients were randomly assigned to receive intravitreous injections of QL1207 or aflibercept 2 mg (0.05 ml) in the study eye every 4 weeks for the first 3 months, followed by 2 mg every 8 weeks until week 48, stratified by baseline BCVA ≥ or < 45 letters. The primary endpoint was BCVA change from baseline at week 12. The equivalence margin was ± 5 letters. The safety, immunogenicity, pharmacokinetics (PK), and plasma vascular endothelial growth factor (VEGF) concentration were also evaluated. RESULTS: A total of 366 patients were enrolled (QL1207 group, n = 185; aflibercept group, n = 181) from Aug 2019 to Jan 2022 with comparable baseline characteristics. The least-squares mean difference in BCVA changes was - 1.1 letters (95% confidence interval - 3.0 to 0.7; P = 0.2275) between the two groups, within the equivalence margin. The incidences of treatment-emergent adverse events (TEAE; QL1207: 71.4% [132/185] vs. aflibercept: 71.8% [130/181]) and serious TEAE (QL1207: 14.1% [26] vs. aflibercept: 12.7% [23]) appeared comparable between treatment groups, and no new safety signal was found. Anti-drug antibody, PK profiles, and VEGF concentration were similar between the two groups. CONCLUSIONS: QL1207 has equivalent efficacy to aflibercept for nAMD with similar safety profiles. It could be used as an alternative anti-VEGF agent for clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov: NCT05345236 (retrospectively registered on April 25, 2022); National Medical Products Administration of China: CTR20190937 (May 20, 2019).

Mental Health, Bullying, and Victimization among Chinese Adolescents.

The purpose of this study was to examine if adolescents who experience anxiety or depression have higher levels of reported bullying victimization or perpetration than those who do not. Based on the existing research, we hypothesized that those who experienced moderate or severe depression and anxiety would have higher rates of bullying victimization and perpetration when compared to those who experienced mild or no depression. This study used an observational design, and data were collected from a convenience sample of adolescents in a large regional high school in an Eastern province of China. The final sample included 1481 adolescents aged 14-19 years who provided complete data for each of the study variables. Demographic data were collected through a four-item demographic survey, bullying perpetration and victimization data were collected using subscales from the Illinois Bully Scale, and anxiety and depression were measured using the Chinese version of the General Anxiety Disorder-7 scale and the Patient Health Questionnaire, respectively. Descriptive analyses, correlational analyses, and multivariate analysis of covariance were used to analyze the data. About 7.1% and 15.2% of participants reported moderate-to-severe depression or moderate-to-severe anxiety, respectively. Pairwise comparisons indicated that adolescents with no or mild depression had significantly lower bullying perpetration than those with moderate-to-severe depression, but those with no or mild anxiety had significantly higher perpetration than those with moderate-to-severe anxiety. There was no statistically significant difference in victimization among different anxiety or depression levels alone (all p-values ≥ 0.05). This is among the first studies to examine reported levels of bullying perpetration and victimization among adolescents experiencing anxiety and depression. The findings help to identify adolescents who experience moderate-to-severe levels of depression as an at-risk group for bullying perpetration, who should therefore be a focus of bullying intervention work.

Academic Stress, Physical Activity, Sleep, and Mental Health among Chinese Adolescents.

The purpose of this study was to examine the impacts of academic stress on physical activity and sleep, and subsequently their impacts on anxiety and depression. METHODS: This cross-sectional study collected data from a convenience sample of 1533 adolescents in an eastern province in China. Surveys were used to collect data on academic stress, anxiety, depression, sleep, physical activity, and demographics. Descriptive statistics, correlation analysis, and path analysis were used to analyze data. RESULTS: The participants reported about 6.77 ± 0.89 h of sleep per day and 1.62 ± 1.79 days of 60 min of physical activity each week. Academic stress was positively correlated with anxiety and depression, which were negatively correlated with physical activity and sleep. The path analysis showed that academic stress directly predicted anxiety (ß = 0.54) and depression (ß = 0.55), and hours of sleep (ß = 0.024) and the number of days of 60 min physical activity (ß = 0.014) mediated the relation. CONCLUSION: The results largely supported our hypotheses and supported the need to lessen academic stress experienced by Chinese adolescents, in effort to enhance mental health indices directly, and by allowing for engagement in health-related behaviors such as physical activity and sleep.

[Clincal outcome in conversion from small incision sutureless to phacoemulsification cataract surgery].

PURPOSE: To investigate the clinical outcome during the conversion from small incision sutureless cataract surgery (SICS) to phacoemulsfication cataract surgery (Phaco). METHODS: During the conversion period from SICS to phaco, 241 cataract cases were assigned to SICS and phaco surgery procedures. The intraoperative complications and early postoperative outcome were assessed. RESULTS: The 1st day visual acuity outcome (VA 0.5 or better) was lower in phaco grouop (p<0.05), however, the visual acuity outcomes were no longer statistically different at 1 week and 1 month visits (p>0.05 for each visit). Among 193 cases operations in phaco group, 51 cases (26.4%) developed corneal edema at 1 day visit, 13 cases(6.7%) had posterior capsular rapture, 5 cases(2.6%) had zonular rupture, 5 cases (2.6%) failed to implant IOL. These rates were higher than what were found in SICS group. CONCLUSIONS: The outcome of phaco cataract surgery is comparable with SICS during this conversion period. Techniques that the surgeons may pay attention to are also discussed.