British Journal of Ophthalmology最新文献

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Exploring metabolic biomarkers in primary and chemoreduced retinoblastoma with patient outcome 探索原发性和化疗减少视网膜母细胞瘤的代谢生物标志物与患者预后
IF 4.1 2区 医学
British Journal of Ophthalmology Pub Date : 2025-04-11 DOI: 10.1136/bjo-2024-326495
Manisha Supriya, Mithalesh Kumar Singh, Lata Singh, Shivam Sharma, Rachna Meel, Neiwete Lomi, Seema Sen, Seema Kashyap
{"title":"Exploring metabolic biomarkers in primary and chemoreduced retinoblastoma with patient outcome","authors":"Manisha Supriya, Mithalesh Kumar Singh, Lata Singh, Shivam Sharma, Rachna Meel, Neiwete Lomi, Seema Sen, Seema Kashyap","doi":"10.1136/bjo-2024-326495","DOIUrl":"https://doi.org/10.1136/bjo-2024-326495","url":null,"abstract":"Aims The goal of this study is to identify the pathological findings and expression of metabolic markers (GLUT-1, PDK-1 and PGC1α) in the tumour microenvironment of both primary and chemoreduced retinoblastoma (Rb) and to correlate with clinicopathological parameters and patient outcome. Methods 81 prospective cases were included, in which 53 cases underwent primary enucleation and 28 cases received chemotherapy before enucleation. Immunohistochemistry, qRT-PCR and western blotting were performed to evaluate the expression pattern of metabolic markers in primary and chemoreduced Rb. Results Tumour microenvironment and histopathological findings were different for both primary and chemoreduced Rb. Increased immunohistochemical expression of GLUT-1, PDK-1 and PGC1α was found in primary Rb as compared with chemoreduced Rb. mRNA expression was also found to be upregulated in primary Rb compared with chemoreduced. On univariate analysis, the presence of more than one histopathological high-risk factor (HRFs>1) and PDK-1 immunoexpression was statistically significant with overall survival. On prognostication in primary and chemoreduced cases with hypoxia, we found increased HR in cases with retrolaminar ON invasion, presence of more than one HRF, and presence of PDK-1 and PGC-1α immunoexpression. Conclusions This is the first of its kind study predicting a relevant role of the metabolic markers in primary and chemoreduced Rb with prognostic significance. Differential expression of these markers in both groups of Rb is a novel finding and might be an interesting and beneficial target for the management of Rb patients. All data relevant to the study are included in the article or uploaded as supplementary information.","PeriodicalId":9313,"journal":{"name":"British Journal of Ophthalmology","volume":"117 1","pages":""},"PeriodicalIF":4.1,"publicationDate":"2025-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143822730","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Meibum and lid margin microbiome in eyes with chalazion: exploring an infectious aetiology 眼睑和眼睑边缘微生物组在眼睛失明的感染病原学探讨
IF 4.1 2区 医学
British Journal of Ophthalmology Pub Date : 2025-04-07 DOI: 10.1136/bjo-2024-325988
Swati Singh, Moumi Maity, Kotakonda Arunasri, Sayan Basu
{"title":"Meibum and lid margin microbiome in eyes with chalazion: exploring an infectious aetiology","authors":"Swati Singh, Moumi Maity, Kotakonda Arunasri, Sayan Basu","doi":"10.1136/bjo-2024-325988","DOIUrl":"https://doi.org/10.1136/bjo-2024-325988","url":null,"abstract":"Purpose The current study evaluated the meibum and lid margin microbiome of eyelids with chalazion and compared it with contralateral uninvolved eyelids and healthy controls. Methods Chalazion contents (group 1) and expressed meibum swabs from the lid margins of seven patients with chalazion (mean age 29±12 years; >6 weeks chalazia duration) and age-matched healthy controls were sequenced using next-generation 16S rDNA V3-V4 variable region sequencing. The meibum from the contralateral eye of patient with chalazion served as sample control (group 2), and healthy individuals served as negative control (group 3). The contents were also plated using conventional culture techniques. Results Meibomian glands expressed thick turbid meibum in the area of chalazion in five out of seven eyelids. Contralateral uninvolved eyelids and healthy control glands were expressible with clear meibum. The mean Schirmer I value was 24.6±4.9 mm. Lid margin and meibum microbiome profiling revealed significant differences between the patients (involved or uninvolved sides) and healthy controls. The predominant phyla were Proteobacteria, Bacteroidota and Actinobacteria in all three groups. Acinetobacter , Moraxella and Paracoccus were the predominant genera in groups 1 and 2. Significant differences were noted in the predominant genera between group 3 versus groups 1 and 2. Principal coordinate analysis revealed overlap between groups 1 and 2, whereas group 3 had a distinct cluster. None of the culture media (for aerobic, anaerobic bacteria and fungus) showed any bacterial growth. Conclusion In patients with unilateral chalazion, involved and uninvolved eyelids share similar lid margin and meibum microbiome but differ from the healthy controls. Data are available upon reasonable request.","PeriodicalId":9313,"journal":{"name":"British Journal of Ophthalmology","volume":"55 1","pages":""},"PeriodicalIF":4.1,"publicationDate":"2025-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143797748","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The eye as a window to oral and pain symptoms in Sjögren’s disease 眼睛是了解斯约格伦病口腔和疼痛症状的窗口
IF 4.1 2区 医学
British Journal of Ophthalmology Pub Date : 2025-04-03 DOI: 10.1136/bjo-2024-326748
Drew C Baeza, Victor Sanchez, Raquel Goldhardt, Sara S McCoy, Fei Tang, Alan Baer, Robert Fox, Anat Galor
{"title":"The eye as a window to oral and pain symptoms in Sjögren’s disease","authors":"Drew C Baeza, Victor Sanchez, Raquel Goldhardt, Sara S McCoy, Fei Tang, Alan Baer, Robert Fox, Anat Galor","doi":"10.1136/bjo-2024-326748","DOIUrl":"https://doi.org/10.1136/bjo-2024-326748","url":null,"abstract":"Background To investigate whether certain dry eye (DE) metrics relate to oral and pain manifestations of Sjögren’s disease (SjD). Methods Secondary analysis of the Sjögren’s International Collaborative Clinical Alliance dataset containing 1541 individuals with 2016 American College of Rheumatology/European League Against Rheumatism defined SjD. Binary logistic regression analyses examined which of 13 DE features related to various extraocular metrics. Results The mean age of the population was 52±13.5 years; 45% identified as white and 94% as women. Heterogeneity in DE symptoms and signs was noted in individuals with SjD, with approximately one-third of individuals reporting significant spontaneous and/or evoked pain using various descriptors and indicating certain triggers, and approximately half having low tear production. Similarly, heterogeneity was noted with respect to oral and pain complaints, with extraocular pain symptoms found in approximately one-third of the population. Different ocular phenotypes aligned with different extraocular findings. Specifically, grittiness or scratchiness in the eyes (OR=1.6), blurred vision (OR=1.4) and low tear production (OR=1.8) most closely aligned with oral dryness (‘Does your mouth feel dry?). On the other hand, burning or stinging in the eyes (OR=1.6), discomfort in low humidity (OR=1.2) and the absence of DE signs (normal tear production, OR=0.7; lack of ocular surface staining, OR=0.6) most closely aligned with pain outside the eye (‘Do you experience persistent or frequent burning discomfort?’). Conclusions Our findings suggest heterogeneity in SjD ocular presentations that predict extraocular features of disease and hint at mechanisms that underlie heterogeneity, namely divergent neurosensory processes. Data are available upon reasonable request. See above.","PeriodicalId":9313,"journal":{"name":"British Journal of Ophthalmology","volume":"26 1","pages":""},"PeriodicalIF":4.1,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143775625","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
At a glance 一目了然
IF 4.1 2区 医学
British Journal of Ophthalmology Pub Date : 2025-04-01 DOI: 10.1136/bjo-2025-327454
Frank Larkin
{"title":"At a glance","authors":"Frank Larkin","doi":"10.1136/bjo-2025-327454","DOIUrl":"https://doi.org/10.1136/bjo-2025-327454","url":null,"abstract":"This study is the first to review patients using the 3C-classification for ocular cystinosis. The classification shows a high correlation for all markers, symptoms and complications of the disease regularly recorded in practice. The spherical equivalent error increases when adding each subclinical oedema feature determined by the tomography in Barrett Universal II, Hoffer QTS, Barrett True K, and Haigis-L formulae in eyes with Fuchs dystrophy undergoing combined DMEK and cataract surgery. By analysing haplotype-tagging single nucelotide polymorphisms, this study confirmed the association of the HTRA1 gene with myopia in Chinese patients. This suggests shared genetic components between myopia and age-related macular degeneration. In this randomised trial of orthokeratology vs single vision spectacles, sub-clinically weak electrophysiological responses at …","PeriodicalId":9313,"journal":{"name":"British Journal of Ophthalmology","volume":"61 1","pages":""},"PeriodicalIF":4.1,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143695428","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
In vivo confocal microscopy confirms the presence of new predescemetic cellular layer in post-penetrating keratoplasty buttons 体内共聚焦显微镜证实在穿透性角膜移植术后的钮扣中存在新的前角膜形成细胞层
IF 4.1 2区 医学
British Journal of Ophthalmology Pub Date : 2025-03-31 DOI: 10.1136/bjo-2024-326878
Niccolò Salgari, Angeli Christy Yu, Serena Panariello, Luigi De Rosa, Massimo Busin
{"title":"In vivo confocal microscopy confirms the presence of new predescemetic cellular layer in post-penetrating keratoplasty buttons","authors":"Niccolò Salgari, Angeli Christy Yu, Serena Panariello, Luigi De Rosa, Massimo Busin","doi":"10.1136/bjo-2024-326878","DOIUrl":"https://doi.org/10.1136/bjo-2024-326878","url":null,"abstract":"Background/aim To investigate the in vivo presence of a natural plane of separation at the pre-Descemet membrane (DM) level in post-penetrating keratoplasty (PK) eyes using confocal microscopy. Methods In vivo confocal microscopy was performed on the corneal stroma of 20 post-PK eyes and 20 keratoplasty-naive healthy control eyes. Patients were recruited from the cornea service of Ospedali Privati Forlì ‘Villa Igea’ between June 2022 and February 2024. The study adhered to the Declaration of Helsinki and was approved by the local ethics committee. Main outcome measures were stromal cell density (SCD) and the pattern of cell distribution. Results Posterior SCD was significantly higher in post-PK eyes compared with controls (387±96 vs 219±30 cell/mm², p<0.0001). A distinct layer densely populated by keratocyte-like cells, corresponding to the last visible row of nuclei before the DM, was observed in post-PK eyes but not in controls. Nuclei of these cells appeared irregularly dispersed or grouped in clusters, and in some cases arranged in columns along a preferred direction. Conclusions A distinct pre-DM layer of keratocyte-like cells is present in post-PK eyes potentially contributing to the previously described natural plane of separation during repeat keratoplasties. Further studies are needed to clarify the origin and clinical implications of this finding. Data are available on reasonable request.","PeriodicalId":9313,"journal":{"name":"British Journal of Ophthalmology","volume":"58 1","pages":""},"PeriodicalIF":4.1,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143745008","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Adverse renal events between ranibizumab and aflibercept in patients with diabetic macular oedema in Taiwan: a comparative cohort study 台湾糖尿病性黄斑水肿患者的肾脏不良事件:一项比较队列研究
IF 4.1 2区 医学
British Journal of Ophthalmology Pub Date : 2025-03-27 DOI: 10.1136/bjo-2024-325509
Wan-Ju Annabelle Lee, Shih-Chieh Shao, Miyuki Hsing-Chun Hsieh, Tzu-Chi Liao, Swu-Jane Lin, Edward Chia-Cheng Lai
{"title":"Adverse renal events between ranibizumab and aflibercept in patients with diabetic macular oedema in Taiwan: a comparative cohort study","authors":"Wan-Ju Annabelle Lee, Shih-Chieh Shao, Miyuki Hsing-Chun Hsieh, Tzu-Chi Liao, Swu-Jane Lin, Edward Chia-Cheng Lai","doi":"10.1136/bjo-2024-325509","DOIUrl":"https://doi.org/10.1136/bjo-2024-325509","url":null,"abstract":"Aims To assess and compare the risk of adverse renal events among patients with diabetic macular oedema (DME) who were treated with either intravitreal ranibizumab or aflibercept in Taiwan. Methods We conducted a population-based retrospective cohort study and employed a target trial emulation framework using Taiwan’s National Health Insurance Database from 2011 to 2018. Patients aged over 20 years diagnosed with DME and receiving treatment with either intravitreal aflibercept or ranibizumab were included. We applied propensity score methods to ensure balance in the baseline characteristics between the two treatment groups. The primary outcomes were the adverse renal events, specifically acute renal injury and hospitalisation due to renal events. We employed Cox proportional hazards models to estimate the HRs associated with these outcomes. Results A total of 6330 patients receiving ranibizumab and 1258 patients receiving aflibercept were included in this study. The incidence rates of adverse renal events were 102.2 and 138.7 per 1000 person-years for ranibizumab and aflibercept, respectively. Patients treated with intravitreal aflibercept had a significantly higher risk of experiencing a composite of adverse renal events (HR: 1.42; 95% CI: 1.24 to 1.63), compared with those treated with ranibizumab, and specifically also a higher risk of acute kidney injury (HR: 1.32; 95% CI: 1.08 to 1.63) and hospitalisation due to renal events (HR: 1.43; 95% CI: 1.25 to 1.64). Conclusion In comparison to ranibizumab, the intravitreal use of aflibercept was associated with a greater risk of adverse renal events. These findings provide a solid foundation for future studies to validate these results further. Data may be obtained from a third party and are not publicly available. The analytic datasets of this study are available in the NHIRD (<http://nhird.nhri.org.tw/en/index.html>) and were managed by National Health Research Institutes in Taiwan. Applicants must follow the Computer-Processed Personal Data Protection Law and related regulations. All applications are reviewed for approval of data release.","PeriodicalId":9313,"journal":{"name":"British Journal of Ophthalmology","volume":"183 1","pages":""},"PeriodicalIF":4.1,"publicationDate":"2025-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143723163","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Rapid clinical assessment of spatial contrast sensitivity changes in retinal disease and ageing 视网膜疾病和衰老中空间对比敏感度变化的快速临床评估
IF 4.1 2区 医学
British Journal of Ophthalmology Pub Date : 2025-03-26 DOI: 10.1136/bjo-2024-326490
Prakash Adhikari, Andrew J. Zele, Beatrix Feigl
{"title":"Rapid clinical assessment of spatial contrast sensitivity changes in retinal disease and ageing","authors":"Prakash Adhikari, Andrew J. Zele, Beatrix Feigl","doi":"10.1136/bjo-2024-326490","DOIUrl":"https://doi.org/10.1136/bjo-2024-326490","url":null,"abstract":"Evidence suggests best-corrected visual acuity is not sensitive to subtle vision losses in early disease stages, indicating the need for other tests. Here, we quantified contrast sensitivity in 99 people (20–88 years): 52 with eye diseases (10 with early AMD, 9 diabetics without retinopathy, 22 glaucoma suspects, 11 high myopes) and 47 age-matched healthy controls using a new spatial vision chart (0.28–100% Weber contrasts; 3–60 c/° frequencies). In retinal diseases and healthy ageing, the chart detected frequency-dependent losses; sensitivity was reduced at 3 and 8 c/° in AMD, at 6 and 8 c/° in diabetes, and at all frequencies in myopia and with ageing. Intrasession repeatability was excellent and spatial contrast changes were in accordance with deficits identified previously using complex and time-consuming psychophysical tests. The chart offers a simple, rapid and readily available tool for clinical use to document early visual deficits.","PeriodicalId":9313,"journal":{"name":"British Journal of Ophthalmology","volume":"29 1","pages":""},"PeriodicalIF":4.1,"publicationDate":"2025-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143713039","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
3-year results of 0.01% and 0.1% loading dose atropine treatment including washout in Danish children with myopia: a placebo-controlled, randomised clinical trial 丹麦近视儿童0.01%和0.1%负荷剂量阿托品治疗包括洗脱期的3年结果:一项安慰剂对照随机临床试验
IF 4.1 2区 医学
British Journal of Ophthalmology Pub Date : 2025-03-23 DOI: 10.1136/bjo-2024-326918
Niklas Hansen, Anders Hvid-Hansen, Flemming Møller, Toke Bek, Dorte Larsen, Nina Jacobsen, Line Kessel
{"title":"3-year results of 0.01% and 0.1% loading dose atropine treatment including washout in Danish children with myopia: a placebo-controlled, randomised clinical trial","authors":"Niklas Hansen, Anders Hvid-Hansen, Flemming Møller, Toke Bek, Dorte Larsen, Nina Jacobsen, Line Kessel","doi":"10.1136/bjo-2024-326918","DOIUrl":"https://doi.org/10.1136/bjo-2024-326918","url":null,"abstract":"Aim To examine the safety and efficacy of low-dose atropine (0.01% and 0.1% loading dose) after 2-year treatment and 1-year washout in 6-year-old to 12-year-old Danish children with myopia. Methods Investigator-initiated, placebo-controlled, double-blind, randomised clinical trial. Of 124 screened children, 97 were randomised to receive 0.01% low-dose atropine for 24 months (0.01%) or 0.1% low-dose atropine for 6 months, then 0.01% for 18 months (0.1% loading dose) or placebo, followed by a 1-year washout. Altogether, 91 participants completed the study. The primary outcome was myopia progression (axial length (AL) and spherical equivalent refraction (SER)). Secondary outcomes were adverse events, ocular biometrical measurements and treatment responder eyes (myopia progression less than −0.50 diopters (D)). Constrained linear mixed models were constructed with individual eyes nested by participant ID, according to intention-to-treat. The responder analysis used Fisher’s exact test. Significance levels were adjusted for multiple comparisons. Adjusted p values <0.05 were considered significant. Results At 3 years, the mean AL was −0.06 mm (95% CI −0.18; 0.07) and −0.09 mm (95% CI −0.21; 0.04) less compared with placebo in the 0.1% loading dose group and 0.01% group. Mean SER was −0.02 D (95% CI −0.30; 0.26) less and 0.17 D (95% CI −0.11; 0.45) more compared with placebo in the 0.1% loading dose group and 0.01% group. There was no significant group difference in the responder eyes. Conclusion There was no difference in myopia progression between groups following washout. A 6-month 0.1% loading dose did not improve efficacy compared with 0.01%. The 0.1% loading dose showed a rebound effect after dose switching. Data are available upon reasonable request. Data is available upon reasonable request from the corresponding author.","PeriodicalId":9313,"journal":{"name":"British Journal of Ophthalmology","volume":"35 1","pages":""},"PeriodicalIF":4.1,"publicationDate":"2025-03-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143677905","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Simultaneous inhibition of fibroblast growth factor-2 and vascular endothelial growth factor-a with RC28-E in diabetic macular edema: a phase 2 randomised trial RC28-E同时抑制成纤维细胞生长因子-2和血管内皮生长因子-a治疗糖尿病黄斑水肿:一项2期随机试验
IF 4.1 2区 医学
British Journal of Ophthalmology Pub Date : 2025-03-23 DOI: 10.1136/bjo-2024-326006
Wenfei Zhang, Shiyu Cheng, Xingwang Gu, Xinyu Liu, Hong Dai, Wenjuan Zhuang, Bin Sun, Lei Gao, Xuguang Sun, Ming Zhang, Zongming Song, Wenxiang Wang, Lin Li, He Chen, Jianmin Fang, Youxin Chen
{"title":"Simultaneous inhibition of fibroblast growth factor-2 and vascular endothelial growth factor-a with RC28-E in diabetic macular edema: a phase 2 randomised trial","authors":"Wenfei Zhang, Shiyu Cheng, Xingwang Gu, Xinyu Liu, Hong Dai, Wenjuan Zhuang, Bin Sun, Lei Gao, Xuguang Sun, Ming Zhang, Zongming Song, Wenxiang Wang, Lin Li, He Chen, Jianmin Fang, Youxin Chen","doi":"10.1136/bjo-2024-326006","DOIUrl":"https://doi.org/10.1136/bjo-2024-326006","url":null,"abstract":"Objective To compare different doses and dosing regimens of RC28-E, a novel bispecific antibody that simultaneously binds vascular endothelial growth factor-A (VEGF-A) and fibroblast growth factor-2 (FGF-2), with conbercept in patients with diabetic macular edema (DME). Design Prospective, randomised, active comparator-controlled, open-label, multicentre, phase 2 clinical trial.cente Participants The trial enrolled patients aged 18 years or older with centre-involving DME, best-corrected visual acuity (BCVA) of 73 to 24 Early Treatment Diabetic Retinopathy Study (ETDRS) letters, and central subfield thickness (CST) of 300 µm or more. Methods Patients were assigned randomly to one of five treatment regimens: 1.0 mg RC28-E for three initial monthly doses and then every 8 weeks (1.0mgQ8); 1.0 mg RC28-E for five initial monthly doses and then on a pro re nata (PRN) basis (1.0mgPRN); 2.0 mg RC28-E for three initial monthly doses and then every 8 weeks (2.0mgQ8); 2.0 mg RC28-E for five initial monthly doses and then on a PRN basis (2.0mgPRN); or 0.5 mg conbercept for three initial monthly doses and then on a PRN basis. Assessments were made at baseline and every 4 weeks thereafter. Main outcome measures The primary endpoint was the change in BCVA compared with baseline at 24 and 52 weeks. Secondary endpoints included the change in CST from baseline at 52 weeks; the proportion of patients who gained/lost ≥15 letters, ≥10 letters and &gt;0 letter in BCVA; and the number of injections and safety outcomes. Results The trial enrolled 156 patients. Mean improvements in BCVA in the RC28-E groups at week 24 were 7.1, 11.0, 7.4 and 10.5 letters for 1.0mgQ8, 1.0mgPRN, 2.0mgQ8 and 2.0mgPRN regimens, respectively, versus 9.7 letters for the conbercept group (p=0.146). By week 52, the RC28-E groups exhibited respective mean BCVA enhancements of 5.5, 9.5, 9.2 and 9.7 letters, compared with 8.4 letters of the conbercept group (p=0.469). Mean reductions in CST in the RC28-E groups at week 52 were −163.2 µm, −136.9 µm, −142.5 µm and −153.6 µm, versus −160.7 µm for the conbercept group (p=0.948). The Per Protocol Set analysis indicated that at 24 weeks, the BCVA improvement in the 2.0mgPRN group was significantly greater than that in the conbercept group (14.0 vs 9.8, p=0.019). In patients with poor baseline glycaemic control (HbA1c ≥7.5%), the 2.0mgPRN group showed greater BCVA improvement than the conbercept group (14.4 vs 4.2, p=0.039) at week 52. During the maintenance phase, the 2.0mgPRN group had fewer injections (2.8, 95% CI 1.8 to 3.7) compared with the conbercept group (4.4, 95% CI 3.5 to 5.2). RC28-E was generally well tolerated. The incidence of ocular adverse events in study eyes was comparable between RC28-E groups (22.6% in 1.0mgQ8 group, 26.7% in 1.0mgPRN group, 34.4% in 2.0mgQ8 group, 25.0% in 2.0 mg PRN group) and conbercept group (32.3%). The number of ocular serious adverse events was 1 (1.0mgQ8), 0 (1.0mgPRN), 1 (2.0mgQ8), 2 (2.0mgPRN) and 0 (conbercept","PeriodicalId":9313,"journal":{"name":"British Journal of Ophthalmology","volume":"18 1","pages":""},"PeriodicalIF":4.1,"publicationDate":"2025-03-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143677994","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Incidence and reasons for discontinuation of anti-VEGF treatment in neovascular age-related macular degeneration 新生血管性年龄相关性黄斑变性患者抗vegf治疗的发生率及停药原因
IF 4.1 2区 医学
British Journal of Ophthalmology Pub Date : 2025-03-23 DOI: 10.1136/bjo-2024-326152
Enrico Borrelli, Claudio Foti, Lorena Ulla, Annamaria Porreca, Ugo Introini, Maria Oliva Grassi, Pasquale Viggiano, Mario Peronetti, Rebecca Toscani, Giacomo Boscia, Alba Chiara Termite, Carlo Gennaro, Paola Marolo, Francesco Boscia, Francesco Bandello, Michele Reibaldi
{"title":"Incidence and reasons for discontinuation of anti-VEGF treatment in neovascular age-related macular degeneration","authors":"Enrico Borrelli, Claudio Foti, Lorena Ulla, Annamaria Porreca, Ugo Introini, Maria Oliva Grassi, Pasquale Viggiano, Mario Peronetti, Rebecca Toscani, Giacomo Boscia, Alba Chiara Termite, Carlo Gennaro, Paola Marolo, Francesco Boscia, Francesco Bandello, Michele Reibaldi","doi":"10.1136/bjo-2024-326152","DOIUrl":"https://doi.org/10.1136/bjo-2024-326152","url":null,"abstract":"Purpose To explore the factors and frequency of interruptions in intravitreal treatment for patients with neovascular age-related macular degeneration (AMD) and to evaluate the demographic and clinical factors linked to the reasons for discontinuation. Methods In this multicentre study, patients who began anti-vascular endothelial growth factor (VEGF) treatment between January 2019 and December 2021 for treatment-naïve neovascular exudative AMD were retrospectively analysed. The overall incidence of treatment discontinuation, along with the rates for each specific cause, was calculated. The probability of each cause of discontinuation over time from the start of treatment, as well as the risk factors associated with each case, was also determined. Results 655 individuals (28.5%) discontinued intravitreal anti-VEGF therapy. Among the five main categories of causes for discontinuation (patient’s decision against clinician’s advice, continuation of therapy at another clinic, clinical decision, systemic diseases or death), clinical decision emerged as the most common reason for interruption. The qualitative evaluation of the Kaplan–Meier curves suggests a higher frequency of the clinical decision as a cause of discontinuation within the initial 2 years of treatment. Worse visual acuity increased the risk of discontinuation due to clinical decisions. Younger patients were more likely to stop anti-VEGF therapy by choice. Better visual acuity and longer distance from the clinic increased the likelihood of patients continuing treatment elsewhere. Conclusions The discontinuation of anti-VEGF treatment is common among individuals with neovascular AMD. Causes of discontinuation include not only clinician decisions but also those related to the patient’s health and personal choices. Data are available upon reasonable request. Data are available upon reasonable request to the corresponding author.","PeriodicalId":9313,"journal":{"name":"British Journal of Ophthalmology","volume":"57 1","pages":""},"PeriodicalIF":4.1,"publicationDate":"2025-03-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143677906","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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