Efficacy of a Treat-and-Extend Regimen With Ranibizumab in Patients With Neovascular Age-Related Macular Disease
| Autor: | Mark Greve, Peter J. Kertes, Geoff Williams, Tom G. Sheidow, Jason Baker, Marcel Lahaie, Ivan J. Galic |
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| Rok vydání: | 2020 |
| Předmět: |
Male
Canada medicine.medical_specialty Time Factors genetic structures Visual Acuity MEDLINE Angiogenesis Inhibitors 01 natural sciences Drug Administration Schedule law.invention Macular Degeneration 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Ranibizumab Internal medicine medicine Humans In patient Prospective Studies 0101 mathematics Aged Aged 80 and over business.industry 010102 general mathematics Macular disease Recovery of Function Macular degeneration medicine.disease Choroidal Neovascularization eye diseases Ophthalmology Regimen Treatment Outcome Choroidal neovascularization Intravitreal Injections 030221 ophthalmology & optometry Female sense organs medicine.symptom business medicine.drug |
| Zdroj: | JAMA Ophthalmology. 138:244 |
| ISSN: | 2168-6165 |
| DOI: | 10.1001/jamaophthalmol.2019.5540 |
| Popis: | Although the Canadian Treat-and-Extend Analysis Trial With Ranibizumab in Patients With Neovascular Age-Related Macular Disease (CANTREAT) reported herein and the Treat and Extend study provided data to show noninferiority of treat-and-extend (TE) at 12 months, to date there are few data on 24-month TE trials compared with monthly dosing.To compare the efficacy of ranibizumab using a TE regimen to monthly dosing in treatment-naive patients with neovascular age-related macular degeneration (nAMD) after 24 months.A randomized, open-label, multicenter, noninferiority intention-to-treat trial with a margin of -5 letters in best-corrected visual acuity (BCVA) from baseline to 12 months between groups was conducted at 27 treatment centers in Canada. Participants included 580 patients with treatment-naive choroidal neovascularization secondary to AMD. The study was conducted from May 8, 2013, to August 28, 2018, and data analysis was performed between August 29 and September 12, 2018.Patients with nAMD were randomized 1:1 to receive intravitreal ranibizumab, 0.5 mg, in either a TE or monthly dosing regimen.Mean change in BCVA in Early Treatment of Diabetic Retinopathy Study letters from baseline to month 24.Of the 580 randomized patients, 350 were women (60.3%) and 547 were white (94.3%). Mean (SD) age was 78.8 (7.8) years. By the end of month 24, 466 of the 580 randomized patients (80.3%) had completed the study and participants in the TE arm received a mean of 17.6 injections compared with 23.5 injections for the monthly arm, for a difference of 5.9 injections and visits over 2 years (95% CI, 5.4-6.5; P .001). The mean (SD) BCVA improvement was not worse with the TE arm, 6.8 (14.1) letters vs 6.0 (12.6) letters, compared with the monthly arm (difference, 0.9; 95% CI, -1.6 to 3.3; P = .21). There was a gain of 15 or more letters in 25.5% of the TE group and 23.1% of the monthly treatment group (difference, 2.4%; 95% CI, -6.8% to 11.6%; P = .59) and a loss of 15 or more letters in 6.5% of the TE group and 5.8% of the monthly treatment group (difference, -0.7%; 95% CI, -9.9% to 8.5%; P = .85).These findings suggest that change in vision from baseline is not worse with a TE compared with a monthly regimen of ranibizumab for nAMD through 24 months, achieving clinically meaningful improvements in BCVA despite fewer injections and visits.ClinicalTrials.gov identifier: NCT02103738. |
| Databáze: | OpenAIRE |
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