Purpose: To evaluate 1-year outcomes of intravitreal injections of aflibercept (IVA) in Japanese polypoidal choroidal vasculopathy (PCV) patients. Methods: In this prospective, open-label, single-arm multicenter clinical trial, treatment-naïve PCV patients received IVA (2.0 mg) every 2 months, after 3 initial monthly doses. The primary endpoint assessed was the proportion of patients maintaining baseline best-corrected visual acuity (BCVA) at 1 year. Results: Fifty eyes with PCV were included in the study. BCVA was maintained or improved in 97.6% of the patients. Mean logMAR BCVA at baseline was 0.33, and had improved to 0.12 logMAR 1 year after the initiation of aflibercept treatment (p < 0.001). Mean central foveal thickness decreased from 356 to 239 μm (p < 0.001). Complete regression of polypoidal lesions was seen in 72.5% after 1 year of treatment. Conclusions: One year of IVA resulted in stabilization of BCVA and anatomical improvement in Japanese PCV patients.

Keywords:
Polypoidal choroidal vasculopathy, Aflibercept, 1-year outcome
1.
Yannuzzi LA, Sorenson J, Spaide RF, Lipson B: Idiopathic polypoidal choroidal vasculopathy (IPCV). Retina 1990;10:1-8.
2.
Yannuzzi LA, Wong DW, Sforzolini BS, Goldbaum M, Tang KC, Spaide RF, Freund KB, Slakter JS, Guyer DR, Sorenson JA, Fisher Y, Maberley D, Orlock DA: Polypoidal choroidal vasculopathy and neovascularized age-related macular degeneration. Arch Ophthalmol 1999;117:1503-1510.
3.
Maruko I, Iida T, Saito M, Nagayama D, Saito K: Clinical characteristics of exudative age-related macular degeneration in Japanese patients. Am J Ophthalmol 2007;144:15-22.
4.
Azab M, Benchaboune M, Blinder KJ, Bressler NM, Bressler SB, Gragoudas ES, Fish GE, Hao Y, Haynes L, Lim JI, Menchini U, Miller JW, Mones J, Potter MJ, Reaves A, Rosenfeld PJ, Strong A, Su XY, Slakter JS, Schmidt-Erfurth U, Sorenson JA; Treatment of Age-Related Macular Degeneration with Photodynamic Therapy (TAP) Study Group; Verteporfin in Photodynamic Therapy (VIP) Study Group: Verteporfin therapy of subfoveal choroidal neovascularization in age-related macular degeneration: meta-analysis of 2-year safety results in three randomized clinical trials: Treatment of Age-Related Macular Degeneration with Photodynamic Therapy and Verteporfin In Photodynamic Therapy Study Report No 4. Retina 2004;24:1-12.
5.
Japanese Age-Related Macular Degeneration Trial (JAT) Study Group: Japanese age-related macular degeneration trial: 1-year results of photodynamic therapy with verteporfin in Japanese patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration. Am J Ophthalmol 2003;136:1049-1061.
6.
Gomi F, Ohji M, Sayanagi K, Sawa M, Sakaguchi H, Oshima Y, Ikuno Y, Tano Y: One-year outcomes of photodynamic therapy in age-related macular degeneration and polypoidal choroidal vasculopathy in Japanese patients. Ophthalmology 2008;115:141-146.
7.
Mitchell P, Korobelnik JF, Lanzetta P, Holz FG, Prünte C, Schmidt-Erfurth U, Tano Y, Wolf S: Ranibizumab (Lucentis) in neovascular age-related macular degeneration: evidence from clinical trials. Br J Ophthalmol 2010;94:2-13.
8.
Kokame GT, Yeung L, Lai JC: Continuous anti-VEGF treatment with ranibizumab for polypoidal choroidal vasculopathy: 6-month results. Br J Ophthalmol 2010;94:297-301.
9.
Koh A, Lee WK, Chen LJ, Chen SJ, Hashad Y, Kim H, Lai TY, Pilz S, Ruamviboonsuk P, Tokaji E, Weisberger A, Lim TH; EVEREST study: Efficacy and safety of verteporfin photodynamic therapy in combination with ranibizumab or alone versus ranibizumab monotherapy in patients with symptomatic macular polypoidal choroidal vasculopathy. Retina 2012;32:1453-1464.
10.
Sato T, Kishi S, Matsumoto H, Mukai R: Combined photodynamic therapy with verteporfin and intravitreal bevacizumab for polypoidal choroidal vasculopathy. Am J Ophthalmol 2010;149:947-954.
11.
Gomi F, Oshima Y, Mori R, Kano M, Saito M, Yamashita A, Iwata E, Maruko R; Fujisan Study Group: Initial versus delayed photodynamic therapy in combination with ranibizumab for treatment of polypoidal choroidal vasculopathy: the Fujisan Study. Retina 2015;35:1569-1576.
12.
Hikichi T, Higuchi M, Matsushita T, Kosaka S, Matsushita R, Takami K, Ohtsuka H, Ariga H: One-year results of three monthly ranibizumab injections and as-needed reinjections for polypoidal choroidal vasculopathy in Japanese patients. Am J Ophthalmol 2012;154:117-124.
13.
Papadopoulos N, Martin J, Ruan Q, Rafique A, Rosconi MP, Shi E, Pyles EA, Yancopoulos GD, Stahl N, Wiegand SJ: Binding and neutralization of vascular endothelial growth factor (VEGF) and related ligands by VEGF Trap, ranibizumab and bevacizumab. Angiogenesis 2012;15:171-185.
14.
Stewart MW, Rosenfeld PJ: Predicted biological activity of intravitreal VEGF Trap. Br J Ophthalmol 2008;92:667-668.
15.
Heier JS, Brown DM, Chong V, Korobelnik JF, Kaiser PK, Nguyen QD, Kirchhof B, Ho A, Ogura Y, Yancopoulos GD, Stahl N, Vitti R, Berliner AJ, Soo Y, Anderesi M, Groetzbach G, Sommerauer B, Sandbrink R, Simader C, Schmidt-Erfurth U; VIEW 1 and VIEW 2 Study Groups: Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration. Ophthalmology 2012;119:2537-2548.
16.
Schmidt-Erfurth U, Kaiser PK, Korobelnik JF, Brown DM, Chong V, Nguyen QD, Ho AC, Ogura Y, Simader C, Jaffe GJ, Slakter JS, Yancopoulos GD, Stahl N, Vitti R, Berliner AJ, Soo Y, Anderesi M, Sowade O, Zeitz O, Norenberg C, Sandbrink R, Heier JS: Intravitreal aflibercept injection for neovascular age-related macular degeneration: ninety-six-week results of the VIEW studies. Ophthalmology 2014;121:193-201.
17.
Yamamoto A, Okada AA, Kano M, Koizumi H, Saito M, Maruko I, Sekiryu T, Iida T: One-year results of intravitreal aflibercept for polypoidal choroidal vasculopathy. Ophthalmology 2015;122:1866-1872.
18.
Saito M, Kano M, Itagaki K, Oguchi Y, Sekiryu T: Switching to intravitreal aflibercept injection for polypoidal choroidal vasculopathy refractory to ranibizumab. Retina 2014;34:2192-2201.
19.
Mori R, Yuzawa M, Akaza E, Haruyama M: Treatment results at 1 year of ranibizumab therapy for polypoidal choroidal vasculopathy in eyes with good visual acuity. Jpn J Ophthalmol 2013;57:365-371.
20.
Lee JE, Shin JP, Kim HW, Chang W, Kim YC, Lee SJ, Chung IY, Lee JE; VAULT study group: Efficacy of fixed-dosing aflibercept for treating polypoidal choroidal vasculopathy: 1-year results of the VAULT study. Graefes Arch Clin Exp Ophthalmol 2017;255:493-502.
21.
Oishi A, Tsujikawa A, Yamashiro K, Ooto S, Tamura H, Nakanishi H, Ueda-Arakawa N, Miyake M, Akagi-Kurashige Y, Hata M, Yoshikawa M, Kuroda Y, Takahashi A, Yoshimura N: One-year result of aflibercept treatment on age-related macular degeneration and predictive factors for visual outcome. Am J Ophthalmol 2015;159:853-860.
22.
Cho HJ, Kim KM, Kim HS, Han JI, Kim CG, Lee TG, Kim JW: Intravitreal aflibercept and ranibizumab injections for polypoidal choroidal vasculopathy. Am J Ophthalmol 2016;165:1-6.
23.
Kikushima W, Sakurada Y, Sugiyama A, Tanabe N, Kume A, Iijima H: Comparison of initial treatment between 3-monthly intravitreal aflibercept monotherapy and combined photodynamic therapy with single intravitreal aflibercept for polypoidal choroidal vasculopathy. Graefes Arch Clin Exp Ophthalmol 2017;255:311-316.
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2017
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