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-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.
Original language | English |
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Pages (from-to) | 462 |
Journal | BMC Ophthalmology |
Volume | 20 |
Issue number | 1 |
DOIs | |
Publication status | Published - Nov 25 2020 |
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
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Dive into the research topics of 'A 12-month, prospective, observational study of ranibizumab in treatment-naïve Taiwanese patients with neovascular age-related macular degeneration: the RACER study'. Together they form a unique fingerprint.Datasets
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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
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
Dataset
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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
Dataset