Treat-and-extend Regimen with Ranibizumab Comparable with Monthly Treatment in Patients with nAMD
In patients with neovascular age-related macular disease (nAMD), a treat-and-extend (T&E) dosing regimen with ranibizumab resulted in clinically meaningful improvement in best-corrected visual acuity (BCVA) that was not worse compared with monthly treatment through 24 months, according to results of a study published in JAMA Ophthalmology.
In this randomized, open-label, multicenter, noninferiority intention-to-treat trial, 580 patients with treatment-naive choroidal neovascularization secondary to AMD were randomized 1:1 to receive 0.5 mg intravitreal ranibizumab, in either a T&E or monthly dosing regimen. Mean (SD) age was 78.8 (7.8) years.
After 24 months, 466 of the 580 randomized patients (80.3%) had completed the study. In the T&E arm, participants received a mean of 17.6 injections compared with 23.5 injections in the monthly arm (95% CI, 5.4-6.5; P < 0.001).
Mean change in BCVA in Early Treatment of Diabetic Retinopathy Study letters from baseline to month 24 were reported. In the T&E group, mean (SD) BCVA improvement from 6.8 (14.1) letters versus 6.0 (12.6) letters was not worse compared with the monthly arm (difference, 0.9; 95% CI, −1.6 to 3.3; P = 0.21). There was a gain of 15 or more letters in 25.5% of the T&E group and 23.1% of the monthly treatment group (difference, 2.4%; 95% CI, −6.8% to 11.6%; P = 0.59) and a loss of 15 or more letters in 6.5% of the T&E group and 5.8% of the monthly treatment group (difference, −0.7%; 95% CI, −9.9% to 8.5%; P = 0.85).
The authors concluded that change in vision from baseline is not worse with a T&E regimen compared with a monthly regimen of ranibizumab for nAMD through 24 months. Fewer injections and visits were needed in the T&E dosing group, “which has the potential to increase convenience and reduce cost to the health care system compared with monthly dosing,” the authors said.
Kertes PJ, Galic IJ, Greve M, et al. Efficacy of a treat-and-extend regimen with ranibizumab in patients with neovascular age-related macular disease: A randomized clinical trial. JAMA Ophthalmol. Published online January 9, 2020. doi:10.1001/jamaophthalmol