Tomohiro Nizawa a , b , Masayasu Kitahashi a , Takayuki Baba a , Takehito Iwase a , Mariko Kubota-Taniai a , Yoko Hattori c , Yuki Shiko c , Yohei Kawasaki c , Takayuki Iwase c , Takatoshi Sato c , Shoko Ogawa c , Takeshi Sugawara c , Shuichi Yamamoto a
20 May 2021
Purpose: We aim to determine the effects of intravitreal aflibercept (IVA) on the mean sensitivity (MS) of the central retina, best-corrected visual acuity (BCVA), and central foveal thickness (CFT) in eyes with neovascular age-related macular degeneration (nAMD) with or without polypoidal choroidal vasculopathy (PCV). Methods: This was a prospective, interventional study. All eyes were treatment-naive with nAMD with or without PCV. Each eye received 3 monthly IVA injections followed by an IVA injection every 2 months for 12 months. The primary outcome was the change in the MS within the central 2°. The secondary outcomes were the changes in BCVA, CFT, greatest linear dimension (GLD), and percentage of eyes with a dry macula. Results: Thirty-seven eyes of 37 patients were studied. A significant improvement of the MS (dB) was observed +4.9 ± 4.6 dB (mean ± standard deviation) at 3 M ( p < 0.001), +5.5 ± 4.9 dB at 6 ( p < 0.001), and +7.0 ± 3.4 dB at 12 M ( p < 0.001) compared to the baseline in all eyes. The MS of the eyes with non-PCV was not significantly different from that of eyes with PCV ( p = 1.00, 1.00, 1.00, and 0.76 at baseline, 3, 6, and 12 M, respectively). The MS of 11 patients whose BCVA remained unchanged was significantly improved by +6.5 ± 2.8 dB at 3 M ( p < 0.001), +6.1 ± 4.3 dB at 6 M ( p < 0.001), and +6.4 ± 4.8 dB at 12 M ( p = 0.003) compared to the baseline. The mean BCVA was significantly improved from the baseline to 3 M ( p < 0.001), 6 M ( p = 0.027), and 12 M ( p = 0.003) in all eyes. The BCVA was improved or maintained in 97% of the patients at 12 M. The mean CFT and GLD were significantly reduced at 12 M ( p < 0.001). Twenty-two eyes (71%) had a dry macula at 12 M. Conclusions: IVA administered by a fixed dosing regimen led to significant improvements of the central MS, BCVA, and macular morphology at 1 year in eyes with nAMD with or without PCV. These results were not significantly different between eyes with non-PCV and with PCV. The improvements of the MS of the retina of the central 2° in a subgroup whose BCVA remained unchanged through the 12-month experimental period was also significant. We conclude that the MS of the central 2° might be a better marker than the BCVA in determining the effectiveness of IVA treatments and might be helpful in determining early effects on the retina before BCVA changes can be detected.