Intravitreal ranibizumab(Sultan Qaboos University Hospital)(Intravitreal ranibizumab(Sultan Qaboos University Hospital)) - 药物靶点：VEGF-A_在研适应症：视网膜发育不良_专利_临床

概要

基本信息

药物类型

Fab片段抗体、生物类似药

别名

Intravitreal ranibizumab(Sultan Qaboos University Hospital)、Ranibizumab biosimilar (Sultan Qaboos University Hospital)、雷珠单抗生物类似药 (Sultan Qaboos University Hospital)

靶点

VEGF-A

作用机制

VEGF-A抑制剂(血管内皮生长因子A抑制剂)

治疗领域

遗传病与畸形眼部疾病

在研适应症

视网膜发育不良

非在研适应症

双等位基因RPE65突变相关的视网膜变性疾病

原研机构

Sultan Qaboos University Hospital

在研机构

Sultan Qaboos University Hospital

非在研机构

University of Sultan Qaboos

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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结构/序列

Sequence Code 103170L

当前序列信息引自: *****

Sequence Code 143622H

当前序列信息引自: *****

关联

2

项与 Intravitreal ranibizumab(Sultan Qaboos University Hospital) 相关的临床试验

NCT03763227

/ Completed临床2期IIT

Efficacy and Safety of Intravitreal Ranibizumab (Lucentis®) Injection in the Treatment of Non-leaking Macular Cysts in Patients With Retinal Dystrophy.

To evaluate the efficacy and safety of intravitreal ranibizumab (IVR) injection in the treatment of non-leaking macular cysts in patients with retinal dystrophy.
Material and Methods:
Design - Prospective, nonrandomized, nonblinded, clinical trial. Participants - Patients >18 years diagnosed with retinal dystrophies and non-leaking macular cysts between Jan 2015 and July 2018 in 1 center.
Methods - Phase 1: Patients with best corrected visual acuity (BCVA) < 0.5 will receive carbonic anhydrase inhibitors (CAI) [oral acetazolamide 500mg/day or topical brinzolamide twice daily] and followed up for three months. Phase 2: Patients who do not show an adequate response with CAI will receive three 0.5mg IVR injection at monthly intervals.
Outcome - 1) Significant reduction (> 10%) of the central macular thickness (CMT), 2) Improvement (> 1 line) in BCVA 3) Presence of any complication.

开始日期2015-07-24

申办/合作机构

University of Sultan Qaboos

NCT02933905

/ CompletedN/AIIT

Influence of the Vitreomacular Interface on the Progression of the Diabetic Macular Edema After Anti-VEGF Injection

Influence of the vitreomacular interface on the progression of diabetic macular edema after treatment with intravitreal injection of vascular endothelial growth factor inhibitors

开始日期2014-01-01

申办/合作机构-

100 项与 Intravitreal ranibizumab(Sultan Qaboos University Hospital) 相关的临床结果

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100 项与 Intravitreal ranibizumab(Sultan Qaboos University Hospital) 相关的转化医学

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100 项与 Intravitreal ranibizumab(Sultan Qaboos University Hospital) 相关的专利（医药）

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493

项与 Intravitreal ranibizumab(Sultan Qaboos University Hospital) 相关的文献（医药）

2024-11-18·International Journal of Ophthalmology

Short-term fluctuation of intraocular pressure and influencing factors following intravitreal injection in patients with retinal vascular diseases

Article

作者: Miao, Jing-Peng ; Zeng, Yi-Yun ; Gu, Xin-Ming ; Gu, Xin-Ming ; Zhang, Xin-Yuan ; Zhang, Xin-Yuan

AIM: To investigate the patterns of short-term intraocular pressure (IOP) fluctuations and identify the contributing factors following intravitreal injection in patients with retinal vascular diseases. METHODS: Totally 81 patients were enrolled in this case control study. Eyes were categorized into 7 groups, including age-related macular degeneration (AMD), polypoidal choroidal vasculopathy (PCV), idiopathic choroidal neovascularization (CNV), proliferative diabetic retinopathy (PDR), diabetic macular edema (DME), macular edema secondary to branch (BVOME) and central (CVOME) retinal vein occlusion. IOP was measured in all patients using rebound tonometer at 7 preset time points perioperatively. Additionally, based on the administered medication, the eyes were classified into three treatment groups, including dexamethasone intravitreal implant (IVO), intravitreal conbercept (IVC), and intravitreal ranibizumab (IVR). To compare IOP values at various time points across groups, we employed one-way ANOVA, independent sample t-test or χ2 test and multivariate logistic regression analysis. RESULTS: Peak IOP values across all groups were observed at 40s, and 5min after intravitreal injection. Statistical differences in IOP were detected at the 5min among the 7 indication groups (F=2.50, P=0.029). When examing the impact of medications, the IVO group exhibited lower average IOP values at both 40s and 5min compared to the IVC and IVR groups (P<0.001; P=0.007). The IOP values at 40s and 5min were significantly higher in BVOME and CVOME group compared to non-retinal vein occlusion-secondary macular edema (RVOME) group (P<0.001). Multivariate logistic regression analysis further confirmed that IOP measurement at 40s was significantly higher in CVOME group than in non-RVOME group (OR=1.64, 95%CI: 1.09-2.47; P=0.018). CONCLUSION: Needle size plays a crucial role in the transient changes of IOP following intravitreal injection. Before administering intravitreal injection to patients with central retinal vein occlusion, it is essential to exclude any underlysing causes of increased IOP.

2024-07-02·Cureus

Comparison of Intravitreal Ranibizumab and Laser Photocoagulation in the Treatment of Type I Retinopathy of Prematurity in Malaysia: A One-Year Follow-Up Study

Article

作者: Rahmat, Jamalia ; Syahmi, Md Razali ; Wardati H, Jami ; Hamzah, Norhafizah ; Khadijah, Mustafa ; Nurul-Farhana, Mustafa ; Lai, Yoon Kit Ivan ; Shatriah, Ismail ; Chew, Fiona Lee Min ; Karimmah, Wahit

PURPOSEThis study aimed to evaluate the treatment efficacy, anatomical outcomes, and refractive outcomes of laser photocoagulation (LPC) and intravitreal ranibizumab (IVR) in the treatment of type I retinopathy of prematurity (ROP) at one-year follow-up.METHODSThis is a retrospective study on the treatment of type I ROP and aggressive ROP (A-ROP) using LPC or IVR in three Malaysian hospitals providing pediatric ophthalmology services from January 2019 to December 2021. Information on gestational age, birth weight, ROP zone and stage, and underlying comorbidities was collected. Parameters for evaluating treatment efficacy include the time taken to achieve complete regression, the regression rate, and the reactivation rate. The anatomical and refractive outcomes were evaluated at one year of adjusted age.RESULTSThis study included 92 eyes from 46 infants. Of these, 42 eyes received LPC as the initial treatment, while 50 eyes underwent IVR. A higher percentage of infants with cardiovascular disease were treated with IVR (66.7%) compared to LPC (40%) (p<0.05). However, there were no significant differences in gestational age, birth weight, respiratory distress syndrome, sepsis, or intraventricular hemorrhage between the two treatment groups (p>0.05). Infants treated with LPC had a higher regression rate than those treated with IVR, but they were also significantly more myopic and had worse best-corrected visual acuity (BCVA). Conversely, infants treated with IVR experienced a significantly higher reactivation rate compared to those treated with LPC. Logistic regression analysis showed no significant associations between gestational age, birth weight, plus disease, zone 1 ROP, and the choice of initial treatment with the reactivation of ROP.CONCLUSIONSBoth LPC and IVR effectively treat type I ROP in infants, with IVR yielding superior anatomical and refractive outcomes and LPC offering a lower reactivation rate. Understanding individual patient characteristics is crucial for treatment selection.

2024-04-18·International Journal of Ophthalmology

Effectiveness of intravitreal ranibizumab for diabetic macular edema in vitrectomized versus non-vitrectomized eyes: a Meta-analysis

Article

作者: Wang, Yi-Heng ; Xu, Qian ; Luan, Jie

AIM: To evaluate the effectiveness and safety of intravitreal ranibizumab (IVR) for diabetic macular edema (DME) in vitrectomized versus non-vitrectomized eyes. METHODS: The PubMed, EMBASE, Web of Science, Cochrane, EBSCO were comprehensively searched for studies comparing vitrectomized and non-vitrectomized eyes with DME. Clinical outcomes of best-corrected visual acuity (BCVA), central macular thickness (CMT), the mean number of intravitreal injection and adverse events were extracted and analyzed. RESULTS: Six studies involving 641 eyes were included. Final visual gain significantly improved and CMT significantly reduced in vitrectomized eyes at 6mo and 12mo visits (P<0.05). Although the mean reduction in CMT among non-vitrectomized eyes was significantly greater than in vitrectomized eyes at the 6mo [mean difference (MD)=53.57, 95% confidence interval (CI): 28.03 to 78.72, P<0.0001] and 12mo (MD=49.65, 95%CI: 19.58 to 79.72, P=0.01), no significant difference was detected in improvement in BCVA at either 6mo (MD=0.05, 95%CI: -0.02 to 0.13, P=0.14) or 12mo (MD=0.03, 95%CI: -0.04 to 0.09, P=0.43). Injection number of ranibizumab in non-vitrectomized eyes was significantly less than that in vitrectomized eyes during 6-month period (MD=0.60, 95%CI: 0.16 to 1.04, P=0.008), while there was no statistically significant difference between the two groups during 12mo of follow-up. CONCLUSION: Evidence from current study suggests that IVR was useful for both vitrectomized group and non-vitrectomized group with DME. Although less reduction in macular thickness is found in vitrectomized group, visual improvement between two groups is similar.

100 项与 Intravitreal ranibizumab(Sultan Qaboos University Hospital) 相关的药物交易

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外链

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
双等位基因RPE65突变相关的视网膜变性疾病	临床2期	-	University of Sultan Qaboos	2015-07-24
视网膜发育不良	临床2期	-	Sultan Qaboos University Hospital	-

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


EURETINA2024	N/A	早产儿视网膜病变	131	Intravitreal injection of Ranibizumab 0.25 mg/0.025 ml	積簾遞糧鹹選製獵蓋襯(範襯鬱鹹鏇簾窪鑰觸餘) = 襯鹽廠積襯鏇製醖鬱鹽齋構齋鏇簾齋淵襯觸製 (鏇觸築鹽糧網鬱廠夢積, 1.37) 更多	积极	2024-09-19
ARVO2023	N/A	早产儿视网膜病变一线	44	Intravitreal ranibizumab 0.2 mg	遞鏇鑰製衊餘鹹淵鏇鑰(蓋繭構積糧鬱鹽蓋製艱) = 獵網築範願襯簾鹹壓壓顧壓遞醖網艱構積鑰窪 (網廠範構淵鏇壓遞網獵 ) 更多	-	2023-06-01
APAO2023	N/A	近视脉络膜新生血管	14	Intravitreal Ranibizumab Injection	(膚衊餘鹹製鹹糧鏇繭窪) = 鬱壓繭窪觸窪糧鹽餘積製壓觸憲廠構獵餘範鹽 (鹹顧窪鬱範憲醖選簾鑰 ) 更多	积极	2023-02-23
EURETINA2022	N/A	糖尿病性黄斑水肿 \| 湿性年龄相关性黄斑变性	-	Intravitreal Ranibizumab Biosimilar	(廠獵鬱艱淵鑰願鏇壓糧) = 積憲壓衊夢網膚鹹鑰積鑰衊鏇鑰淵壓觸築願窪 (願淵構獵夢範蓋廠積窪 ) 更多	积极	2022-09-01
EURETINA2022	N/A	湿性年龄相关性黄斑变性	-	Intravitreal ranibizumab (0.5 mg)	簾網淵製窪構願衊鏇襯(憲窪壓廠鏇構艱網壓範) = decrease of PWV after the first (by 0.34 m/s) and the second injection (by 0.31 m/s) and remained decreased 1 month after the third injection (overall P<0.05) 蓋膚網糧製鹹鏇蓋遞積 (繭齋觸繭齋鑰構顧膚襯 ) 更多	-	2022-09-01
				Placebo
APAO2021	N/A	视网膜静脉阻塞	81	Intravitreal Ranibizumab Monthly	(鹽襯鏇遞壓艱衊襯繭顧) = 獵膚憲憲窪製簾製顧顧選鬱糧顧遞鑰繭壓齋鹹 (齋艱艱願獵簾製膚製遞, 193.18)	积极	2021-09-05
				Intravitreal Ranibizumab PRN	(鹽襯鏇遞壓艱衊襯繭顧) = 壓簾艱夢廠鬱觸簾鏇製選鬱糧顧遞鑰繭壓齋鹹 (齋艱艱願獵簾製膚製遞, 108.92)
APAO2021	N/A	脉络膜新生血管	-	Intravitreal Ranibizumab Monthly Protocol	顧繭憲鹽膚糧衊壓鹹醖(鹽糧遞繭築鬱憲憲窪鏇) = 築鏇網鬱艱餘鑰製鏇網壓艱鑰鹹蓋顧獵顧膚積 (範鹹衊選遞鬱網壓淵糧 ) 更多	-	2021-09-05
				Intravitreal Ranibizumab PRN Protocol	顧繭憲鹽膚糧衊壓鹹醖(鹽糧遞繭築鬱憲憲窪鏇) = 獵淵壓齋廠簾鏇願鏇鑰壓艱鑰鹹蓋顧獵顧膚積 (範鹹衊選遞鬱網壓淵糧 ) 更多
APAO2021	N/A	糖尿病性视网膜病变	-	Monthly Intravitreal Ranibizumab	鹽鬱鏇醖遞衊願衊壓顧(糧淵鑰膚顧膚憲蓋積鏇) = 蓋醖觸築鹽淵襯夢壓壓壓衊願鹹觸廠膚齋艱鹽 (繭鏇窪簾夢構鹽鏇齋遞, 73.25)	-	2021-09-05
				Pro Re Nata (PRN) Intravitreal Ranibizumab	鹽鬱鏇醖遞衊願衊壓顧(糧淵鑰膚顧膚憲蓋積鏇) = 膚窪網遞顧鏇憲範廠廠壓衊願鹹觸廠膚齋艱鹽 (繭鏇窪簾夢構鹽鏇齋遞, 63.05)
EURETINA2021	N/A	视网膜静脉阻塞相关黄斑水肿	-	Intravitreal injection of Ranibizumab	(蓋廠構憲鑰製鬱構廠獵) = 築願膚網範淵築廠築繭齋觸築廠糧範鹹襯齋夢 (構網願憲築鹹獵簾鏇顧 ) 更多	-	2021-09-01
ARVO2018	临床2期	黄斑水肿	40	Intravitreal Ranibizumab Monthly	(鏇選鏇構構憲遞築糧齋) = 衊艱衊顧鬱淵鬱範壓築選繭鬱壓艱鑰餘糧遞鏇 (蓋醖構觸蓋鏇廠網繭顧 )	-	2018-07-01
				Intravitreal Ranibizumab Monthly with targeted PRP	(鏇選鏇構構憲遞築糧齋) = 簾襯襯壓鏇夢鬱觸膚繭選繭鬱壓艱鑰餘糧遞鏇 (蓋醖構觸蓋鏇廠網繭顧 )