A 12-month, prospective, observational study of ranibizumab in treatment-naïve Taiwanese patients with neovascular age-related macular degeneration: the RACER study

Wen-Chuan Wu; Jiann-Torng Chen; Ching-Yao Tsai; Chien-Liang Wu; Cheng-Kuo Cheng; Yun-Dun Shen; Arslan Tsai; Pei-Chang Wu

doi:10.1186/s12886-020-01715-3

A 12-month, prospective, observational study of ranibizumab in treatment-naïve Taiwanese patients with neovascular age-related macular degeneration: the RACER study

Wen-Chuan Wu, Jiann-Torng Chen, Ching-Yao Tsai, Chien-Liang Wu, Cheng-Kuo Cheng, Yun-Dun Shen, Arslan Tsai, Pei-Chang Wu

研究成果: 雜誌貢獻 › 文章 › 同行評審

4 引文斯高帕斯（Scopus）

摘要

BACKGROUND: The current National Health Insurance scheme in Taiwan reimburses 3 initial plus 4 additional injections of ranibizumab 0.5 mg for eligible patients with neovascular age-related macular degeneration (nAMD). The Ranibizumab AMD Clinical Efficacy in Real-world practice (RACER) study aimed to observe the effectiveness of ranibizumab injections under this reimbursement system.

METHODS: RACER was a 12-month, prospective, observational study conducted in treatment-naïve, adult Taiwanese patients with nAMD. Patients received intravitreal ranibizumab 0.5 mg injections in adherence with local prescribing information.

RESULTS: Of 161 patients enrolled, 114 (70.8%) completed the 12-month study. Overall, patients received a mean (standard deviation [SD]) of 4.3 (1.7) ranibizumab injections. The mean (SD, [95% confidence interval], P value) gain in best-corrected visual acuity (BCVA) from baseline at Month 3 was 5.2 (12.2, [3.1, 7.3] letters, P
CONCLUSIONS: Treatment with ranibizumab 0.5 mg resulted in significant improvements in visual outcomes among treatment-naïve Taiwanese patients with nAMD. Early treatment and frequent dosing in the real-world setting may be the key to achieving better outcomes.

原文	英語
頁（從 - 到）	462
期刊	BMC Ophthalmology
卷	20
發行號	1
DOIs	https://doi.org/10.1186/s12886-020-01715-3
出版狀態	已發佈 - 11月 25 2020

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10.1186/s12886-020-01715-3

A 12-month, prospective, observational study of ranibizumab in treatment-naïve Taiwanese patients with neovascular age-related macular degeneration: the RACER study
Wu, W.-C. (Creator), Chen, J.-T. (Contributor), Tsai, C.-Y. (Creator), Wu, C.-L. (Creator), Cheng, C.-K. (Contributor), Shen, Y.-D. (Contributor), Tsai, A. (Creator) & Wu, P.-C. (Creator), Figshare, 2020
DOI: 10.6084/m9.figshare.c.5219755.v1, https://springernature.figshare.com/collections/A_12-month_prospective_observational_study_of_ranibizumab_in_treatment-na_ve_Taiwanese_patients_with_neovascular_age-related_macular_degeneration_the_RACER_study/5219755/1
資料集: Dataset
Additional file 1 of A 12-month, prospective, observational study of ranibizumab in treatment-naïve Taiwanese patients with neovascular age-related macular degeneration: the RACER study
Wu, C.-L. (Creator), Cheng, C.-K. (Contributor), Wu, P.-C. (Creator), Tsai, A. (Creator), Chen, J.-T. (Contributor), Shen, Y.-D. (Contributor), Wu, W.-C. (Creator) & Tsai, C.-Y. (Creator), Figshare, 2020
DOI: 10.6084/m9.figshare.13290664.v1, https://doi.org/10.6084%2Fm9.figshare.13290664.v1
資料集: Dataset

引用此

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title = "A 12-month, prospective, observational study of ranibizumab in treatment-na{\"i}ve Taiwanese patients with neovascular age-related macular degeneration: the RACER study",

abstract = "BACKGROUND: The current National Health Insurance scheme in Taiwan reimburses 3 initial plus 4 additional injections of ranibizumab 0.5 mg for eligible patients with neovascular age-related macular degeneration (nAMD). The Ranibizumab AMD Clinical Efficacy in Real-world practice (RACER) study aimed to observe the effectiveness of ranibizumab injections under this reimbursement system.METHODS: RACER was a 12-month, prospective, observational study conducted in treatment-na{\"i}ve, adult Taiwanese patients with nAMD. Patients received intravitreal ranibizumab 0.5 mg injections in adherence with local prescribing information.RESULTS: Of 161 patients enrolled, 114 (70.8%) completed the 12-month study. Overall, patients received a mean (standard deviation [SD]) of 4.3 (1.7) ranibizumab injections. The mean (SD, [95% confidence interval], P value) gain in best-corrected visual acuity (BCVA) from baseline at Month 3 was 5.2 (12.2, [3.1, 7.3] letters, P < 0.0001) and at Month 12 was 3.4 (15.4, [0.2-6.6] letters, P = 0.0352). Mean central retinal thickness also decreased from baseline at Months 3 and 12 (both P < 0.001). In subgroup analyses, better treatment outcomes at Months 3 and 12 were observed among patients who received a loading dose and those who had a shorter duration of nAMD at baseline. Adverse events were reported in 58.4% of patients; most (94.4%) were mild-to-moderate in severity and 98.8% were deemed unrelated to study treatment.CONCLUSIONS: Treatment with ranibizumab 0.5 mg resulted in significant improvements in visual outcomes among treatment-na{\"i}ve Taiwanese patients with nAMD. Early treatment and frequent dosing in the real-world setting may be the key to achieving better outcomes.",

keywords = "Adult, Angiogenesis Inhibitors/therapeutic use, Humans, Intravitreal Injections, Macular Degeneration/drug therapy, Prospective Studies, Ranibizumab/therapeutic use, Taiwan/epidemiology, Tomography, Optical Coherence, Treatment Outcome, Vascular Endothelial Growth Factor A, Visual Acuity",

author = "Wen-Chuan Wu and Jiann-Torng Chen and Ching-Yao Tsai and Chien-Liang Wu and Cheng-Kuo Cheng and Yun-Dun Shen and Arslan Tsai and Pei-Chang Wu",

year = "2020",

month = nov,

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doi = "10.1186/s12886-020-01715-3",

language = "English",

volume = "20",

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number = "1",

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T1 - A 12-month, prospective, observational study of ranibizumab in treatment-naïve Taiwanese patients with neovascular age-related macular degeneration

T2 - the RACER study

AU - Wu, Wen-Chuan

AU - Chen, Jiann-Torng

AU - Tsai, Ching-Yao

AU - Wu, Chien-Liang

AU - Cheng, Cheng-Kuo

AU - Shen, Yun-Dun

AU - Tsai, Arslan

AU - Wu, Pei-Chang

PY - 2020/11/25

Y1 - 2020/11/25

N2 - BACKGROUND: The current National Health Insurance scheme in Taiwan reimburses 3 initial plus 4 additional injections of ranibizumab 0.5 mg for eligible patients with neovascular age-related macular degeneration (nAMD). The Ranibizumab AMD Clinical Efficacy in Real-world practice (RACER) study aimed to observe the effectiveness of ranibizumab injections under this reimbursement system.METHODS: RACER was a 12-month, prospective, observational study conducted in treatment-naïve, adult Taiwanese patients with nAMD. Patients received intravitreal ranibizumab 0.5 mg injections in adherence with local prescribing information.RESULTS: Of 161 patients enrolled, 114 (70.8%) completed the 12-month study. Overall, patients received a mean (standard deviation [SD]) of 4.3 (1.7) ranibizumab injections. The mean (SD, [95% confidence interval], P value) gain in best-corrected visual acuity (BCVA) from baseline at Month 3 was 5.2 (12.2, [3.1, 7.3] letters, P < 0.0001) and at Month 12 was 3.4 (15.4, [0.2-6.6] letters, P = 0.0352). Mean central retinal thickness also decreased from baseline at Months 3 and 12 (both P < 0.001). In subgroup analyses, better treatment outcomes at Months 3 and 12 were observed among patients who received a loading dose and those who had a shorter duration of nAMD at baseline. Adverse events were reported in 58.4% of patients; most (94.4%) were mild-to-moderate in severity and 98.8% were deemed unrelated to study treatment.CONCLUSIONS: Treatment with ranibizumab 0.5 mg resulted in significant improvements in visual outcomes among treatment-naïve Taiwanese patients with nAMD. Early treatment and frequent dosing in the real-world setting may be the key to achieving better outcomes.

AB - BACKGROUND: The current National Health Insurance scheme in Taiwan reimburses 3 initial plus 4 additional injections of ranibizumab 0.5 mg for eligible patients with neovascular age-related macular degeneration (nAMD). The Ranibizumab AMD Clinical Efficacy in Real-world practice (RACER) study aimed to observe the effectiveness of ranibizumab injections under this reimbursement system.METHODS: RACER was a 12-month, prospective, observational study conducted in treatment-naïve, adult Taiwanese patients with nAMD. Patients received intravitreal ranibizumab 0.5 mg injections in adherence with local prescribing information.RESULTS: Of 161 patients enrolled, 114 (70.8%) completed the 12-month study. Overall, patients received a mean (standard deviation [SD]) of 4.3 (1.7) ranibizumab injections. The mean (SD, [95% confidence interval], P value) gain in best-corrected visual acuity (BCVA) from baseline at Month 3 was 5.2 (12.2, [3.1, 7.3] letters, P < 0.0001) and at Month 12 was 3.4 (15.4, [0.2-6.6] letters, P = 0.0352). Mean central retinal thickness also decreased from baseline at Months 3 and 12 (both P < 0.001). In subgroup analyses, better treatment outcomes at Months 3 and 12 were observed among patients who received a loading dose and those who had a shorter duration of nAMD at baseline. Adverse events were reported in 58.4% of patients; most (94.4%) were mild-to-moderate in severity and 98.8% were deemed unrelated to study treatment.CONCLUSIONS: Treatment with ranibizumab 0.5 mg resulted in significant improvements in visual outcomes among treatment-naïve Taiwanese patients with nAMD. Early treatment and frequent dosing in the real-world setting may be the key to achieving better outcomes.

KW - Adult

KW - Angiogenesis Inhibitors/therapeutic use

KW - Humans

KW - Intravitreal Injections

KW - Macular Degeneration/drug therapy

KW - Prospective Studies

KW - Ranibizumab/therapeutic use

KW - Taiwan/epidemiology

KW - Tomography, Optical Coherence

KW - Treatment Outcome

KW - Vascular Endothelial Growth Factor A

KW - Visual Acuity

U2 - 10.1186/s12886-020-01715-3

DO - 10.1186/s12886-020-01715-3

M3 - Article

C2 - 33238968

SN - 1471-2415

VL - 20

SP - 462

JO - BMC Ophthalmology

JF - BMC Ophthalmology

IS - 1

ER -

A 12-month, prospective, observational study of ranibizumab in treatment-naïve Taiwanese patients with neovascular age-related macular degeneration: the RACER study

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A 12-month, prospective, observational study of ranibizumab in treatment-naïve Taiwanese patients with neovascular age-related macular degeneration: the RACER study

Additional file 1 of A 12-month, prospective, observational study of ranibizumab in treatment-naïve Taiwanese patients with neovascular age-related macular degeneration: the RACER study

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