Ophthalmology and Therapy最新文献

筛选
英文 中文
One-Year Outcomes of Aflibercept in Treat-and-Extend Versus Pro Re Nata Regimens for Bevacizumab-Resistant Diabetic Macular Edema: A Real-World Study. 阿弗利百普治疗贝伐珠单抗耐药糖尿病黄斑水肿的 "治疗-延长 "方案与 "Pro Re Nata "方案的一年疗效对比:真实世界研究。
IF 2.6 3区 医学
Ophthalmology and Therapy Pub Date : 2024-11-22 DOI: 10.1007/s40123-024-01067-x
Zubeyir Yozgat, Mehmed Ugur Isik, Mehmet Cem Sabaner
{"title":"One-Year Outcomes of Aflibercept in Treat-and-Extend Versus Pro Re Nata Regimens for Bevacizumab-Resistant Diabetic Macular Edema: A Real-World Study.","authors":"Zubeyir Yozgat, Mehmed Ugur Isik, Mehmet Cem Sabaner","doi":"10.1007/s40123-024-01067-x","DOIUrl":"https://doi.org/10.1007/s40123-024-01067-x","url":null,"abstract":"<p><strong>Introduction: </strong>The aim of this study was to compare the efficacy of the treat-and-extend (TAE) regimen versus the pro re nata (PRN) regimen in patients with bevacizumab-resistant diabetic macular edema (DME) treated with aflibercept, with or without adjunctive laser therapy.</p><p><strong>Methods: </strong>Ninety-one eyes from 91 patients who were switched to aflibercept after three consecutive intravitreal bevacizumab injections for the treatment of DME were included in this retrospective real-world study. The patients were categorized into three groups: TAE (n = 30), TAE + laser (n = 31), and PRN (n = 30). Changes in best-corrected visual acuity and central macular subfield thickness (CMST) at 12, 24, and 52 weeks were defined as the primary functional and anatomical outcomes.</p><p><strong>Results: </strong>A total of 91 eyes from 91 patients (49.5% female) with a mean age of 63.9 ± 7.1 years were included in the analysis. At 52 weeks, the mean letter gains were 8.03, 8.90, and 10.23 in the TAE, TAE + laser, and PRN groups, respectively. Anatomical improvements, as measured by CMST reduction, were 55.33 µm, 33.35 µm, and 48.96 µm in the TAE, TAE + laser, and PRN groups, respectively. The average number of injections administered was 7.7, 8.1, and 8.1, respectively. The final extension interval for the TAE group was 8.7 weeks, compared to 9.5 weeks in the TAE + laser group.</p><p><strong>Conclusions: </strong>The PRN group demonstrated the highest functional improvement while the TAE group showed the greatest anatomical improvement. Overall, both anatomical and functional outcomes in the TAE regimen were comparable to the PRN regimen in patients with bevacizumab-resistant diabetic macular edema.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142686958","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
One-Year Comparison of Efficacy and Safety of PreserFlo MicroShunt with Mitomycin C Applied by Sub-Tenon Injection Versus Sponge. PreserFlo MicroShunt 使用腱膜下注射与海绵注射丝裂霉素 C 一年后的疗效和安全性比较。
IF 2.6 3区 医学
Ophthalmology and Therapy Pub Date : 2024-11-22 DOI: 10.1007/s40123-024-01074-y
Nora Majtanova, Adriana Takacova, Veronika Kurilova, Libor Hejsek, Juraj Majtan, Petr Kolar
{"title":"One-Year Comparison of Efficacy and Safety of PreserFlo MicroShunt with Mitomycin C Applied by Sub-Tenon Injection Versus Sponge.","authors":"Nora Majtanova, Adriana Takacova, Veronika Kurilova, Libor Hejsek, Juraj Majtan, Petr Kolar","doi":"10.1007/s40123-024-01074-y","DOIUrl":"https://doi.org/10.1007/s40123-024-01074-y","url":null,"abstract":"<p><strong>Introduction: </strong>This study was performed to compare the efficacy and safety of PreserFlo MicroShunt (PMS) implantation with mitomycin C (MMC) applied by sub-tenon injection versus conventional application by MMC-soaked sponges.</p><p><strong>Methods: </strong>This retrospective, 1-year cohort study included 100 eyes of 100 patients with glaucoma who underwent PMS implantation with MMC (0.4 mg/ml) delivered either by sub-tenon injection (50 eyes) or via soaked sponges (50 eyes). The primary outcome measure at 1 year was intraocular pressure (IOP) reduction, with complete success defined as an IOP reduction of ≥ 20% and achieving a target IOP of ≤ 21 or 18 mmHg without the use of medication. Secondary outcomes, including corneal endothelial cell density (CECD) loss, the number of medications, and complications, were assessed and compared between the groups.</p><p><strong>Results: </strong>Sustained reductions in mean IOP were observed in both groups over the 1-year follow-up, with no significant differences between the groups. The complete success rate, with a target IOP of ≤ 21 mmHg after 1 year, was 19.3% in the sponge group and 26.4% in the injection group. The qualified success rate was 59.0% and 87.4% in the sponge and injection groups, respectively. A longer survival rate was observed in the injection group than in the sponge group when IOP was below 21 mmHg. The mean CECD significantly decreased (P < 0.01) from baseline to each postoperative follow-up time point in both groups. At 1 year postoperatively, the percentage of total CECD loss was 8.1% in the sponge group and 8.0% in the injection group. However, no significant differences in mean CECD values, the number of medications, or adverse events were found between the groups.</p><p><strong>Conclusions: </strong>PMS implantation with sub-tenon injection of MMC was comparable in terms of efficacy and safety to traditional MMC delivery via soaked sponges. However, the injection group demonstrated a significantly higher success rate than the sponge group.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142686751","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Pooled Multicenter Safety Analysis of Lupin's Intravitreal Biosimilar Ranibizumab (Ranieyes) in Chorioretinal Vascular Diseases. 罗平公司的雷珠单抗(Ranieyes)静脉注射生物仿制药在脉络膜视网膜血管疾病中的多中心汇总安全性分析。
IF 2.6 3区 医学
Ophthalmology and Therapy Pub Date : 2024-11-19 DOI: 10.1007/s40123-024-01065-z
Debdulal Chakraborty, Tushar Kanti Sinha, Sourav Sinha, Aniruddha Maiti, Angshuman Mukherjee, Krishnendu Nandi, Sudipta Das, Saptorshi Majumdar, Dinesh Rungta, Ranabir Bhattacharya
{"title":"Pooled Multicenter Safety Analysis of Lupin's Intravitreal Biosimilar Ranibizumab (Ranieyes) in Chorioretinal Vascular Diseases.","authors":"Debdulal Chakraborty, Tushar Kanti Sinha, Sourav Sinha, Aniruddha Maiti, Angshuman Mukherjee, Krishnendu Nandi, Sudipta Das, Saptorshi Majumdar, Dinesh Rungta, Ranabir Bhattacharya","doi":"10.1007/s40123-024-01065-z","DOIUrl":"10.1007/s40123-024-01065-z","url":null,"abstract":"<p><strong>Introduction: </strong>This study aims to evaluate the ocular and systemic safety profiles of intravitreal biosimilar ranibizumab Ranieyes (Lupin Pharmaceuticals, Mumbai, India) in real-world clinical settings across multiple chorioretinal vascular diseases, including neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and retinal vein occlusion (RVO) in adults.</p><p><strong>Methods: </strong>We conducted a retrospective, consecutive, interventional, uncontrolled multicenter study using data from three hospital networks in India. A total of 1401 eyes received 2194 injections of Ranieyes between June 2022 and November 2023. Patients were followed for a minimum of 6 months, and data on ocular and systemic adverse events (AEs) were collected and analyzed.</p><p><strong>Results: </strong>The study population included 636 male patients and 533 female patients, with a mean age of 58.63 ± 11.54 years. The average number of injections per eye was 1.49 ± 0.23, with the highest frequency in the nAMD group (mean of 2.3 ± 0.23 injections per eye) over 6 months. Non-serious adverse events (nsAEs) were observed in 26.83% of injections, with mild ocular pain and transient blurring of vision being the most common. Serious ocular adverse events were rare, occurring in 0.85% of eyes, with retinal pigment epithelial tear (RPE TEAR) being the most frequent. Systemic adverse events were noted in 5.03% of patients, and all but one were non-serious. One patient developed non-fatal myocardial infarction, the causal relationship of which, however, was not established with the intravitreal agent used. No cases of endophthalmitis were observed.</p><p><strong>Conclusions: </strong>This large-scale, real-world study demonstrates that Ranieyes is a safe intravitreal antivascular endothelial growth factor (anti-VEGF) agent across various chorioretinal vascular diseases. The safety profile of Ranieyes is consistent with that of the reference product, making it a viable option in resource-constrained settings.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142668562","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Evaluation of the Performance of an Ocular Surface Modulator Containing ST-Lysyal Versus Hyaluronic Acid Eyedrops in Patients with Dry Eye Disease: A Pilot Study. 评估含 ST-Lysyal 的眼表调节剂与透明质酸眼药水在干眼症患者中的效果:试点研究。
IF 2.6 3区 医学
Ophthalmology and Therapy Pub Date : 2024-11-19 DOI: 10.1007/s40123-024-01062-2
Stefano Barabino, Andrea Rosa, Sara Marini, Carlo Domenico Bianchi, Maurizio Rolando
{"title":"Evaluation of the Performance of an Ocular Surface Modulator Containing ST-Lysyal Versus Hyaluronic Acid Eyedrops in Patients with Dry Eye Disease: A Pilot Study.","authors":"Stefano Barabino, Andrea Rosa, Sara Marini, Carlo Domenico Bianchi, Maurizio Rolando","doi":"10.1007/s40123-024-01062-2","DOIUrl":"10.1007/s40123-024-01062-2","url":null,"abstract":"<p><strong>Introduction: </strong>Dry eye disease (DED) is a multifactorial condition of the ocular surface, primarily treated with tear substitutes, which do not fully restore natural tear functions. In this pilot study, we tested the hypothesis that T-Lysyal (T-Lys) improves symptoms and signs in patients with DED. Additionally, we provide a literature overview on the effects of T-Lys in ophthalmology and non-ophthalmology conditions to elucidate its mechanisms of action.</p><p><strong>Methods: </strong>A double-masked, randomized pilot study was conducted in patients with DED treated with T-Lys or hyaluronic acid (HA) 0.2% combined with tamarind seeds polysaccharide (control group) for 2 months. Inclusion criteria were a diagnosis of DED with symptoms lasting ≥ 6 months, Symptom Assessment in Dry Eye (SANDE) score ≥ 30, and at least one of the following: fluorescein staining of the cornea (score ≥ 3, NEI scale), conjunctival staining (Lissamine Green, score ≥ 3), or tear breakup time (T-BUT) ≤ 10 s. Data from the right eye were used for statistical analysis. A PubMed literature search of T-Lys studies was also performed without publication year restrictions.</p><p><strong>Results: </strong>Twelve patients in the T-Lys group and 15 in the control group completed the study (mean age 67 ± 11 years). T-Lys treatment resulted in significant improvements from baseline (V0) to 2 months (V2) in symptoms assessed by visual analogue scale (T-Lys: 4.58 ± 2.57 mm at V0, 2.92 ± 1.38 mm at V2, p < 0.05; control: 5.13 ± 2.29 mm at V0, 5.3 ± 2.4 mm at V2), T-BUT (T-Lys: 2.58 ± 1.31 s at V0, 3.58 ± 1.37 s at V2, p < 0.05; control: 3.07 ± 1.43 s at V0, 3 ± 1.13 s at V2), and corneal staining (T-Lys: 2.16 ± 4.17 at V0, 1.41 ± 3.70 at V2, p < 0.05; control: 1.4 ± 2.19 at V0, 1.4 ± 2.16 at V2). No adverse events were reported. Literature findings supported T-Lys's efficacy in managing both ophthalmology and non-ophthalmology conditions.</p><p><strong>Conclusion: </strong>This study provides the first clinical evidence of T-Lys efficacy in patients with DED, supporting preclinical data and highlighting its potential as a promising ocular surface modulator.</p><p><strong>Trial registration: </strong>The study was registered in the ISRCTN registry for Clinical Studies with no. 13587929.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142668561","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Assessment of Large Language Models in Cataract Care Information Provision: A Quantitative Comparison. 白内障护理信息提供中的大型语言模型评估:定量比较。
IF 2.6 3区 医学
Ophthalmology and Therapy Pub Date : 2024-11-08 DOI: 10.1007/s40123-024-01066-y
Zichang Su, Kai Jin, Hongkang Wu, Ziyao Luo, Andrzej Grzybowski, Juan Ye
{"title":"Assessment of Large Language Models in Cataract Care Information Provision: A Quantitative Comparison.","authors":"Zichang Su, Kai Jin, Hongkang Wu, Ziyao Luo, Andrzej Grzybowski, Juan Ye","doi":"10.1007/s40123-024-01066-y","DOIUrl":"https://doi.org/10.1007/s40123-024-01066-y","url":null,"abstract":"<p><strong>Introduction: </strong>Cataracts are a significant cause of blindness. While individuals frequently turn to the Internet for medical advice, distinguishing reliable information can be challenging. Large language models (LLMs) have attracted attention for generating accurate, human-like responses that may be used for medical consultation. However, a comprehensive assessment of LLMs' accuracy within specific medical domains is still lacking.</p><p><strong>Methods: </strong>We compiled 46 commonly inquired questions related to cataract care, categorized into six domains. Each question was presented to the LLMs, and three consultant-level ophthalmologists independently assessed the accuracy of their responses on a three-point scale (poor, borderline, good) and their comprehensiveness on a five-point scale. A majority consensus approach established the final rating for each response. Responses rated as 'Poor' were prompted for self-correction and reassessed.</p><p><strong>Results: </strong>For accuracy, ChatGPT-4o and Google Bard both achieved average sum scores of 8.7 (out of 9), followed by ChatGPT-3.5, Bing Chat, Llama 2, and Wenxin Yiyan. In consensus-based ratings, ChatGPT-4o outperformed Google Bard in the 'Good' rating. For completeness, ChatGPT-4o had the highest average sum score of 13.22 (out of 15), followed by Google Bard, ChatGPT-3.5, Llama 2, Bing Chat, and Wenxin Yiyan. Detailed performance data reveal nuanced differences in model capabilities. In the 'Prevention' domain, apart from Wenxin Yiyan, all other models were rated as 'Good'. All models showed improvement in self-correction. Bard and Bing improved 1/1 from 'Poor' to better, Llama improved 3/4, and Wenxin Yiyan improved 4/5.</p><p><strong>Conclusions: </strong>Our findings emphasize the potential of LLMs, particularly ChatGPT-4o, to deliver accurate and comprehensive responses to cataract-related queries, especially in prevention, indicating potential for medical consultation. Continuous efforts to enhance LLMs' accuracy through ongoing strategies and evaluations are essential.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-11-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142625343","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Patient and Physician Perspectives of Diabetic Retinopathy and Diabetic Macular Edema Diagnosis, Treatment and Progression: A Podcast Article. 患者和医生对糖尿病视网膜病变和糖尿病黄斑水肿诊断、治疗和进展的看法:播客文章。
IF 2.6 3区 医学
Ophthalmology and Therapy Pub Date : 2024-11-06 DOI: 10.1007/s40123-024-01053-3
Daniel Newman, Bernadette Warren, Randall Barker, Charles C Wykoff, Stela Vujosevic
{"title":"Patient and Physician Perspectives of Diabetic Retinopathy and Diabetic Macular Edema Diagnosis, Treatment and Progression: A Podcast Article.","authors":"Daniel Newman, Bernadette Warren, Randall Barker, Charles C Wykoff, Stela Vujosevic","doi":"10.1007/s40123-024-01053-3","DOIUrl":"https://doi.org/10.1007/s40123-024-01053-3","url":null,"abstract":"<p><p>Diabetic retinopathy (DR) is one of the leading causes of vision loss among people of working age. However, people with diabetes are often unaware of the importance of DR screening for preserving vision, highlighting the importance of patient education about DR and DR-related ocular and systemic comorbidities. In this podcast, three patients with different stages of DR and two ophthalmologists exchanged their views on diagnosis, treatment, and progression of DR and diabetic macular edema. The discussion revealed that DR affects not only the physical aspects of patients' lives but also their mental wellbeing. The challenges of a DR diagnosis can be compounded by communication gaps that exist between patients, physicians, and the pharmaceutical industry. Development of new therapies is currently informed mainly by physician perspectives. However, the large burden of current treatments calls for new therapeutic approaches that meet patients' needs better. The preferred method of treatment administration can differ from patient to patient and the choices between treatments that necessitate repeated visits, monitoring, and at-home care must be discussed. As such, going forward it is crucial to consider both the physician and patient perspectives in shaping the clinical landscape of DR.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142583959","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Diagnostic Accuracy of Automated Diabetic Retinopathy Image Assessment Software: IDx-DR and RetCAD. 自动糖尿病视网膜病变图像评估软件:IDx-DR 和 RetCAD 的诊断准确性。
IF 2.6 3区 医学
Ophthalmology and Therapy Pub Date : 2024-11-06 DOI: 10.1007/s40123-024-01049-z
Andrzej Grzybowski, Piotr Brona, Tomasz Krzywicki, Paisan Ruamviboonsuk
{"title":"Diagnostic Accuracy of Automated Diabetic Retinopathy Image Assessment Software: IDx-DR and RetCAD.","authors":"Andrzej Grzybowski, Piotr Brona, Tomasz Krzywicki, Paisan Ruamviboonsuk","doi":"10.1007/s40123-024-01049-z","DOIUrl":"https://doi.org/10.1007/s40123-024-01049-z","url":null,"abstract":"<p><strong>Introduction: </strong>Automated diabetic retinopathy (DR) screening using artificial intelligence has the potential to improve access to eye care by enabling large-scale screening. However, little is known about differences in real-world performance between available algorithms. This study compares the diagnostic accuracy of two AI screening platforms, IDx-DR and RetCAD, for detecting referable diabetic retinopathy (RDR).</p><p><strong>Methods: </strong>Retinal images from 758 patients with diabetes were collected during screening from various clinics in Poland. Each patient was graded by three graders with 320 patients graded by Polish and 438 patients graded by Indian graders, with the majority decision serving as the reference standard. The images were evaluated independently by the IDx-DR and RetCAD algorithms. Sensitivity, specificity, positive and negative predictive values, and agreement between algorithms and human graders were calculated and statistically compared.</p><p><strong>Results: </strong>IDx-DR demonstrated higher sensitivity of 99.3% but lower specificity of 68.9% for RDR detection compared to RetCAD which had 89.4% sensitivity and 94.8% specificity. The positive predictive value was higher for RetCAD (96.4% vs 48.1% for IDx-DR) while the negative predictive value was higher for IDx-DR (99.5% vs 83.1% for RetCAD). Both algorithms achieved high sensitivity (> 95%) for sight-threatening diabetic retinopathy detection.</p><p><strong>Conclusion: </strong>In this direct comparison using the same patient cohort, the two algorithms showed differences in their operating parameters for RDR screening. IDx-DR prioritized avoiding false negatives over false positives while RetCAD maintained a more balanced trade-off. These results highlight the variable performance of current artificial intelligence screening solutions and suggest the importance of considering algorithm performance metrics when deploying automated diabetic retinopathy screening programs, based on available healthcare resources.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142583948","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Nonclinical Similarity of the Biosimilar Candidate ABP 938 with Aflibercept Reference Product. 生物仿制药候选药物 ABP 938 与 Aflibercept 参考产品的非临床相似性。
IF 2.6 3区 医学
Ophthalmology and Therapy Pub Date : 2024-11-06 DOI: 10.1007/s40123-024-01043-5
Neungseon Seo, Scott Kuhns, Dina A Andrews, Alexander Colbert, Vincent Chow, Jennifer Liu
{"title":"Nonclinical Similarity of the Biosimilar Candidate ABP 938 with Aflibercept Reference Product.","authors":"Neungseon Seo, Scott Kuhns, Dina A Andrews, Alexander Colbert, Vincent Chow, Jennifer Liu","doi":"10.1007/s40123-024-01043-5","DOIUrl":"https://doi.org/10.1007/s40123-024-01043-5","url":null,"abstract":"<p><strong>Introduction: </strong>ABP 938 is being developed as a biosimilar to Eylea<sup>®</sup> (aflibercept reference product [RP]), an anti-vascular endothelial growth factor (VEGF) drug used in the management of retinal diseases. Previously, a comparative analytical similarity assessment demonstrated that ABP 938 and aflibercept RP have the same amino acid sequence and exhibit similar higher-order structure and biological activity. The nonclinical studies described here were designed to assess the in vitro pharmacology and the in vivo pharmacokinetics (PK), toxicokinetics (TK), and safety profiles of ABP 938 compared to aflibercept RP.</p><p><strong>Methods: </strong>In vitro target-binding kinetics and affinity for VEGF-A and placental growth factor (PIGF) isoforms were evaluated using surface plasmon resonance (SPR). Effector functions were assessed by cell-based assays. PK was evaluated in a nonterminal intravitreal (IVT) ocular distribution study in rabbits. Safety was assessed in a 1-month IVT study in cynomolgus monkeys.</p><p><strong>Results: </strong>SPR results demonstrated that ABP 938 is similar to aflibercept RP in binding kinetics and affinity for VEGF-A<sub>111</sub>, VEGF-A<sub>121</sub>, VEGF-A<sub>165</sub>, VEGF-A<sub>189</sub>, PlGF-1, and PlGF-2 isoforms. No antibody-dependent cellular cytotoxicity, antibody-dependent cellular phagocytosis, or complement-dependent cytotoxicity was observed with ABP 938 and aflibercept RP. Results from the nonterminal ocular distribution study in rabbits indicated that there were no meaningful differences in the distribution kinetics between intravitreally injected ABP 938 and aflibercept RP. Additionally, there was no evidence of ocular or systemic toxicity associated with IVT administration of ABP 938 in a repeat-dose, 1-month toxicology study in cynomolgus monkeys; toxicokinetic and toxicology profiles were similar to aflibercept RP.</p><p><strong>Conclusions: </strong>This integrated assessment of results from the in vitro pharmacology assessment and in vivo PK and TK/toxicology profiles formed the nonclinical portion of the totality of evidence demonstrating ABP 938 is a biosimilar to aflibercept RP.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142583911","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Validation of the Zarit Burden Interview in Informal Caregivers of Patients with Severe Visual Impairment and Blindness. 严重视力障碍和失明患者非正式照顾者的 Zarit 负担访谈验证。
IF 2.6 3区 医学
Ophthalmology and Therapy Pub Date : 2024-11-02 DOI: 10.1007/s40123-024-01050-6
Raul E Ruiz-Lozano, Monica I Herrera-Rodriguez, Jazmin A Mendoza-Pallares, Natalia Reyes-Godinez, Veronica E Tamez-Tamez, Eugenia M Ramos-Dávila, Luis G Villagomez-Valdez, Lucas A Garza-Garza, Manuel E Quiroga-Garza, Ali Khodor, Jose J Gongora-Cortes, Alejandro Rodriguez-Garcia
{"title":"Validation of the Zarit Burden Interview in Informal Caregivers of Patients with Severe Visual Impairment and Blindness.","authors":"Raul E Ruiz-Lozano, Monica I Herrera-Rodriguez, Jazmin A Mendoza-Pallares, Natalia Reyes-Godinez, Veronica E Tamez-Tamez, Eugenia M Ramos-Dávila, Luis G Villagomez-Valdez, Lucas A Garza-Garza, Manuel E Quiroga-Garza, Ali Khodor, Jose J Gongora-Cortes, Alejandro Rodriguez-Garcia","doi":"10.1007/s40123-024-01050-6","DOIUrl":"https://doi.org/10.1007/s40123-024-01050-6","url":null,"abstract":"<p><strong>Introduction: </strong>The needs of family caregivers providing care to relatives with visual impairment are often dismissed, leading to caregiver burden. The Zarit Burden Interview (ZBI) can measure the caregiver burden of caring for a family member with vision impairment. The purpose of this study is to validate the ZBI in Mexican family caregivers of patients with visual impairment.</p><p><strong>Methods: </strong>The ZBI was applied to 137 family caregivers of patients with visual acuity ≤ 20/200 in the best eye for ≥ 6 months. The ZBI's reliability was determined using Cronbach's α and the factor structure using exploratory factor analysis (EFA, principal axis factoring with promax rotation). Items with loadings < 0.400 were eliminated. Retained factors were determined using the scree test and Horn's parallel analysis (95% CI). Associations between burden factors and other variables were evaluated with descriptive and inferential statistics.</p><p><strong>Results: </strong>Mean ZBI score was 26.2 ± 13.1, and internal consistency was high (α = 0.871). EFA yielded four factors: (1) embarrassment and frustration, (2) self-efficacy expectations, (3) interference in personal relationships, and (4) personal strain. The α values ranged from 0.649 to 0.812. Spousal caregivers had significantly higher scores (factors 1, 2, and 4), whereas adult children had less scores (factor 3). There was a significant positive correlation between hours of daily caregiving and factors 2 (r = 0.350) and 3 (r = 0.388). A worse degree of visual impairment was associated with higher mean factor scores in all factors.</p><p><strong>Conclusions: </strong>The ZBI is a valid instrument to detect burden in Mexican caregivers of patients with visual impairment. We identified a four-factor structure that improved our understanding of the ZBI's underlying constructs. Interventions targeting specific types of burden are warranted.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142564883","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Effect of Ritanserin and Duloxetine on the Gene Expression of Primary Aniridia and Healthy Human Limbal Stromal Cells, In Vitro. 利坦色林和度洛西汀对体外原发性阿尼西泮和健康人眼睑基质细胞基因表达的影响
IF 2.6 3区 医学
Ophthalmology and Therapy Pub Date : 2024-11-01 Epub Date: 2024-09-21 DOI: 10.1007/s40123-024-01032-8
Zhen Li, Nóra Szentmáry, Fabian N Fries, Shweta Suiwal, Ning Chai, Berthold Seitz, Lei Shi, Maryam Amini, Tanja Stachon
{"title":"Effect of Ritanserin and Duloxetine on the Gene Expression of Primary Aniridia and Healthy Human Limbal Stromal Cells, In Vitro.","authors":"Zhen Li, Nóra Szentmáry, Fabian N Fries, Shweta Suiwal, Ning Chai, Berthold Seitz, Lei Shi, Maryam Amini, Tanja Stachon","doi":"10.1007/s40123-024-01032-8","DOIUrl":"10.1007/s40123-024-01032-8","url":null,"abstract":"<p><strong>Introduction: </strong>In congenital aniridia caused by mutations in paired box 6 (PAX6), PAX6 influences the migration and differentiation of limbal epithelial cells (LECs), thereby playing a pivotal role in aniridia-associated keratopathy. The antidepressants ritanserin and duloxetine affect PAX6 expression in LECs. Limbal stromal cells, which support limbal epithelial stem cells, are crucial in the limbal stem cell niche. This study explores how ritanserin and duloxetine influence gene expression in primary human limbal stromal cells from subjects with congenital aniridia and from healthy subjects, in vitro.</p><p><strong>Methods: </strong>Primary human limbal stromal cells from corneas affected by aniridia (AN-LSCs) (n = 8) and from healthy corneas (LSCs) (n = 8) were isolated and cultured in either low-glucose serum-free (LGSF) or normal-glucose serum-containing (NGSC) media. Cells were treated with 4 µM ritanserin or duloxetine for 24 h. Quantitative PCR (qPCR) and western blot were used to assess the expression of PAX6, FOSL2, TGF-β1, ACTA2A1, LUM, COL1A1, COL5A1, DSG1, FABP5 and ADH7.</p><p><strong>Results: </strong>In AN-LSCs with LGSF-medium, ritanserin increased PAX6 messenger RNA (mRNA) (p = 0.007) and decreased TGF-β1 and FOSL2 mRNA levels (P = 0.005, P = 0.038). In addition, TGF-β1 protein levels decreased with both treatments (P = 0.02, P = 0.007), and FABP5 protein level increased, using ritanserin (P = 0.019). In LSCs with LGSF-medium, ACTA2A1 mRNA levels decreased using ritanserin and duloxetine (P = 0.028; P = 0.031), while FABP5 mRNA levels increased with ritanserin treatment (P = 0.003). Also, duloxetine use reduced α-SMA protein (P = 0.013) and increased FABP5 protein levels (P = 0.029). In LSCs with NGSC-medium, ritanserin elevated LUM, FABP5 and ADH7 mRNA and protein levels (P = 0.025, P = 0.003, P = 0.047, P = 0.024, P = 0.013, P = 0.039).</p><p><strong>Conclusions: </strong>The results of our study confirmed that the antipsychotropic drugs ritanserin and duloxetine alter PAX6 and TGF-β1 gene expression in AN-LSCs cultured in LGSF-medium. These drugs were found to have an impact on retinoic acid signaling pathways and keratocyte characteristic markers both in LSCs and AN-LSCs, using different culture media.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"2931-2950"},"PeriodicalIF":2.6,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11494677/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142292801","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
0
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
相关产品
×
本文献相关产品
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信