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This study is a single-center, retrospective, cross-sectional study. It plan to investigate the predictors for asthma exacerbation in long term follow up real world management with analyzing big data of electronic medical records (EMR).

开始日期2018-10-22

申办/合作机构

Ajou University

[+1]

NCT02834663 / Completed临床4期IIT

Prospective, Single-center, Six-month Study of Intravitreal Ranibizumab for Macular Edema With Nonproliferative Diabetic Retinopathy: Effects on Microaneurysm Turnover and Non-perfused Retinal Area

Title of study:
Effects of Ranibizumab to delay or regression non-proliferative diabetic retinopathy(NPDR) with DME assessed by microaneurysm changes: A pilot study Objectives Diabetic retinopathy (DR) is a major cause of visual impairment. Anti-vascular endothelial growth factors have demonstrated therapeutic benefits in diabetic macular edema (DME). We aimed to prospectively analyze the effects of early intensive treatment using intravitreal ranibizumab (IVR) injections in nonproliferative diabetic retinopathy patients with macular edema.
Primary objective:
To investigate other efficacy endpoints including other visual acuity, anatomical change in mild-to-moderate NPDR with DME after intravitreal Ranibizumab injection from baseline through 6 months after treatment.
Secondary objectives:
To compare microvascular changes assessed by microaneurysm counts and perifoveal non-perfusion area changes and safty in eyes of mild-to-moderate NPDR with DME after intravitreal Ranibizumab injection from baseline through 6 months after treatment.

开始日期2016-08-01

申办/合作机构

Wonkwang University Hospital

[+1]

NCT02427295 / Unknown status临床4期IIT

Long-term (up to 3 Years) Clinical and Hormonal Outcomes in Acromegalic Patients With Treated Surgery With or Without Long Acting Somatostatin Analogues: Open-labeled, Prospective, Parallel Group Study

Long-term (up to 3 years) clinical and hormonal outcomes in acromegalic patients with treated surgery with or without long acting somatostatin analogues.

开始日期2014-03-01

申办/合作机构

Asan Medical Center

[+1]

100 项与 Novartis Korea Ltd. 相关的临床结果

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0 项与 Novartis Korea Ltd. 相关的专利（医药）

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25

项与 Novartis Korea Ltd. 相关的文献（医药）

2024-11-01·Ophthalmology and Therapy

Predictors of Disease Activity After Anti-VEGF Treatment for Neovascular Age-Related Macular Degeneration Using Real-World Data from the PROOF Study

Article

作者: Cho, Heeyoon ; Kang, Se Woong ; Jo, Young Joon ; Kim, Jeonghee ; Chin, Hee Seung ; Byon, Iksoo ; Kim, Yu Cheol ; Kim, Jae Hui ; Woo, Se Joon ; Sagong, Min ; Chae, Jae Eun ; Lee, Young Hoon

INTRODUCTIONThe aim of this study was to investigate the predictive factors for persistent disease activity following anti-vascular endothelial growth factors (anti-VEGF) and their long-term effects in patients to be treated for neovascular age-related macular degeneration (nAMD) under real-world conditions.METHODSRetrospective data analysis of the PROOF study, a multi-center real-world retrospective chart review conducted across Korea in patients with nAMD included treatment-naive patients with nAMD who received first anti-VEGF (ranibizumab, bevacizumab, or aflibercept) between January 2017 and March 2019 was performed. All 600 patients (cohort 1) had a minimum follow-up of 12 months of which 453 patients (cohort 2) were followed-up for 24 months from baseline.RESULTSAt month 12 after anti-VEGF therapy, 58.10% (95% confidence interval [CI]: 54.09, 62.12) of patients and at month 24, 66.02% of patients continued to have persistent retinal fluid. At both months 12 and 24, predictive factors for persistent disease activity were fibrovascular pigment epithelial detachments (PED) (P = 0.0494) and retinal fluid at month 3 after loading phase (P = 0.0082). The mean changes in visual acuity were + 6.2, + 10.1, and + 13.3 letters and in the central subfield thickness were - 79.1 µm, - 96.3 µm, and - 134.4 µm at 12 months from baseline, in the bevacizumab, aflibercept, and ranibizumab groups, respectively.CONCLUSIONSThe presence of retinal fluid after loading phase and fibrovascular PED were predictors of persistent disease activity after at least 1 year of anti-VEGF treatment.

2022-06-30·Blood Research

Safety and efficacy of nilotinib in adult patients with chronic myeloid leukemia: a post-marketing surveillance study in Korea

Article

作者: Yuh, Young Jin ; Cheong, June-Won ; Lim, Sung-Nam ; Son, Sang Kyun ; Chang, Myung Hee ; Kim, Min Kyoung ; Jung, Chul Won ; Lee, Won Sik ; Park, Jinny ; Kim, Hawk ; Lee, Seryeon ; Ryoo, Hun-Mo ; Cho, Su-Hee ; Kim, Inho ; Park, Moo-Rim ; Choi, Chul Won ; Kim, Byung Soo ; Ahn, Seo-Yeon ; Lee, Ho Sup ; Kim, Dong-Wook ; Lee, Gyu Hyung ; Lee, Jae Hoon ; Zang, Dae Young ; Seong, Chu Myoung ; Joo, Inkyung ; Oh, Suk-Joong ; Kwon, Jihyun ; Jo, Deog-Yeon ; Kim, Sung-Hyun ; Kim, Hoon-Gu

BackgroundNilotinib is a tyrosine kinase inhibitor approved by the Ministry of Food and Drug Safety for frontline and 2nd line treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). This study aimed to confirm the safety and efficacy of nilotinib in routine clinical practice within South Korea.MethodsAn open-label, multicenter, single-arm, 12-week observational post-marketing surveillance (PMS) study was conducted on 669 Korean adult patients with Ph+ CML from December 24, 2010, to December 23, 2016. The patients received nilotinib treatment in routine clinical practice settings. Safety was evaluated by all types of adverse events (AEs) during the study period, and efficacy was evaluated by the complete hematological response (CHR) and cytogenetic response.ResultsDuring the study period, AEs occurred in 61.3% (410 patients, 973 events), adverse drug reactions (ADRs) in 40.5% (271/669 patients, 559 events), serious AEs in 4.5% (30 patients, 37 events), and serious ADRs in 0.7% (5 patients, 8 events). Furthermore, unexpected AEs occurred at a rate of 6.9% (46 patients, 55 events) and unexpected ADRs at 1.2% (8 patients, 8 events). As for the efficacy results, CHR was achieved in 89.5% (442/494 patients), and minor cytogenetic response or major cytogenetic response was achieved in 85.8% (139/162 patients).ConclusionThis PMS study shows consistent results in terms of safety and efficacy compared with previous studies. Nilotinib was well tolerated and efficacious in adult Korean patients with Ph+ CML in routine clinical practice settings.

2022-03-01·The Korean Journal of Internal Medicine4区 · 医学

How myeloproliferative neoplasms patients’ experience and expectations differ from physicians’: the international MPN Landmark survey

4区 · 医学

ArticleOA

作者: Choi, Eun-Ji ; Jung, Chul Won ; Eom, Ki-Seong ; Kim, Hye-Seon ; Bang, Soo-Mee ; Park, Jiwon ; Choi, Chul Won ; Byun, Ja Min

Background/Aims: Recent advances in the understanding of the pathophysiology of myeloproliferative neoplasms (MPN) were not paralleled with advances in treatment options; thus many questions regarding optimal MPN management remain unanswered. Here, we report the results of descriptive survey study of Korean MPN patients and their attending physicians.Methods: A total of 105 Korean patients (myelofibrosis [MF], 39; polycythemia vera [PV], 25; essential thrombocythemia [ET], 41) and 30 physicians completed the Landmark Health Survey, then data from the survey were analyzed.Results: Among the MPN-Symptom Assessment Form symptoms, the most severe symptom reported was ‘fatigue or tiredness’ in MF and ET patients and ‘itching’ in PV patients. The majority of the patients agreed that MPN reduced their quality of life (QoL). Interestingly, physicians gave higher scores regarding the impact of MPN on patient’s daily and social life compared to patients themselves. For patients, the most important treatment goal was symptom improvement regardless of MPN subtype, while for physicians the highest priority for treatment was better QoL regardless of MPN subtype. Generally, both patients and physicians were satisfied with the overall treatment/management of MPN and communications. However, many patients felt there was not enough time during the appointment for discussion, while many physicians felt they lacked effective drugs to offer to their patients.Conclusions: Our study suggests there are room for better-standardized monitoring of symptoms and treatment options and those continuous efforts to bridge the gap between patients and physicians are necessary for better care of MPN patients.

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