Журнал клинической и экспериментальной офтальмологии
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Effect of a Single-Dose Regimen of Intravitreal Ranibizumab in the Treatment of Neovascular Age-Related Macular Degeneration

Sayaka Ikemori, Aki Kato, Tsutomu Yasukawa, Tomoaki Hattori, Miho Nozaki, Hiroshi Morita, Yoshio Hirano, Munenori Yoshida and Yuichiro Ogura

Purpose: The purpose of this study was to demonstrate the effect of a single-dose regimen for treating AMD.
Methods: Patients (mean age, 75.5 years; range, 60-86) were enrolled who had AMD with a baseline Logarithm of Minimum Angle of Resolution (logMAR) Best-Corrected Visual Acuities (BCVAs) of 0.15 to 1.30 treated with intravitreal ranibizumab as the primary treatment. Eleven eyes (11 patients) received the three-injection loading regimen (3+PRN), and 21 eyes (20 patients) received the single-injection regimen (1+PRN). The mean follow-up period was 16.0 months. In the maintenance phase, additional treatment was administered when subretinal or intraretinal fluid persisted or recurred, BCVA decreased, new subretinal or retinal hemorrhage was observed, or choroidal neovascularization enlarged. The BCVAs and central retinal thickness were measured at baseline and months 3, 6, and 12 during the observation period.
Results: The mean number of injections in the 1+PRN group was 3.52 ± 1.97, significantly (p<0.05) fewer than the 4.83 ± 3.03 in the 3+PRN group. The mean BCVAs at baseline, 3, 6, and 12 months were 0.49, 0.37, 0.31, and 0.30 in the 3+PRN group and 0.57, 0.43, 0.38, and 0.41 in the 1+PRN group. The BCVA improved in six eyes (54.5%) in the 3+PRN group and 12 (57.1%) eyes in the 1+PRN group. At month 12, a 20% or greater decrease in central retinal thickness occurred in five (45.5%) eyes in the 3+PRN group and 12 (57.1%) eyes in the 1+PRN group. There was no significant difference in the BCVAs and central retinal thicknesses at any points in either group.
Conclusions: A single-dose regimen can lead to equivalent functional and morphologic retinal improvement with fewer injections compared with the loading regimen. Further studies are needed to determine the optimal intravitreal ranibizumab treatment regimen for the first 3 months.
This clinical trial is registered in UMIN-CTR (UMIN-ID: UMIN000006968).