Canadian Treat-and-Extend Analysis Trial with Ranibizumab in Patients with Neovascular Age-Related Macular Disease: One-Year Results of the Randomized Canadian Treat-and-Extend Analysis Trial with Ranibizumab Study.
Ophthalmology
; 126(6): 841-848, 2019 06.
Article
en En
| MEDLINE
| ID: mdl-30677465
ABSTRACT
PURPOSE:
To compare the efficacy of ranibizumab using a treat-and-extend (T&E) regimen with monthly dosing in treatment-naive patients with neovascular age-related macular degeneration (nAMD).DESIGN:
Prospective, randomized, open-label, multicenter, noninferiority, postauthorization study.PARTICIPANTS:
Treatment-naive patients with choroidal neovascularization secondary to AMD.METHODS:
Patients with nAMD were randomized 11 to receive intravitreal ranibizumab at a dose of 0.5 mg in either a T&E or monthly dosing regimen. The noninferiority of T&E compared with the monthly dosing regimen was to be shown using a margin of 5 letters in best-corrected visual acuity (BCVA) improvement. MAIN OUTCOMEMEASURES:
Mean change in BCVA in Early Treatment Diabetic Retinopathy Study letters from baseline to month 12.RESULTS:
Baseline and 12-month visual acuity data are available for 526 patients (T&E, n = 268; 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.
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Neovascularización Coroidal
/
Inhibidores de la Angiogénesis
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Degeneración Macular Húmeda
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Ranibizumab
Tipo de estudio:
Clinical_trials
/
Diagnostic_studies
/
Guideline
/
Observational_studies
Límite:
Aged
/
Aged80
/
Female
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Humans
/
Male
País/Región como asunto:
America do norte
Idioma:
En
Año:
2019
Tipo del documento:
Article