Canadian Treat-and-Extend Analysis Trial with Ranibizumab in Patients with Neovascular Age-Related Macular Disease
| Autor: | Tom G. Sheidow, Ivan J. Galic, Andrea Scarino, Peter J. Kertes, Emmanouil Rampakakis, R. Geoff Williams, Mark Greve |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
0303 health sciences
medicine.medical_specialty Visual acuity genetic structures business.industry Treat and extend Confidence interval law.invention 03 medical and health sciences Ophthalmology Regimen 0302 clinical medicine Randomized controlled trial law Internal medicine 030221 ophthalmology & optometry medicine Dosing Ranibizumab medicine.symptom business Prospective cohort study 030304 developmental biology medicine.drug |
| Zdroj: | Ophthalmology. 126:841-848 |
| ISSN: | 0161-6420 |
| DOI: | 10.1016/j.ophtha.2019.01.013 |
| Popis: | Purpose To compare the efficacy of ranibizumab using a treat-and-extend (TE monthly, n = 258). At baseline, mean age was 78.8 years (standard deviation [SD], 7.8 years), 60.3% were women, and 94.3% were white. No significant between-group baseline differences were observed. The primary outcome of noninferiority regarding visual acuity was met with mean BCVA improvement of 8.4 letters (SD, 11.9 letters) and 6.0 letters (SD, 11.9 letters; P = 0.017) in the T&E and monthly regimens, respectively, with a between-group mean difference of 2.38 letters (95% confidence interval, 0.32–4.45 letters). Per protocol, a secondary analysis was performed to test for superiority of number of injections received up to month 12. This analysis demonstrated significantly fewer injections with T&E versus monthly dosing (9.4 and 11.8 injections, respectively), with a mean difference of –2.46 injections (95% confidence interval, –2.68 to –2.23 injections). Conclusions The 12-month results of this 2-year study demonstrated that regarding visual outcomes, the T&E regimen was noninferior to a monthly dosing regimen. Similar visual outcomes in the T&E group as in the monthly dosing group were achieved with significantly fewer injections. |
| Databáze: | OpenAIRE |
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