Efficacy and safety of intravitreal aflibercept injection in wet age-related macular degeneration: outcomes in the Japanese subgroup of the VIEW 2 study

被引:41
作者
Ogura, Yuichiro [1 ]
Terasaki, Hiroko [2 ]
Gomi, Fumi [3 ]
Yuzawa, Mitsuko [4 ]
Iida, Tomohiro [5 ]
Honda, Miki [6 ]
Nishijo, Koichi [7 ]
Sowade, Olaf [8 ]
Komori, Tetsushi [7 ]
Schmidt-Erfurth, Ursula [9 ]
Simader, Christian [10 ]
Chong, Victor [11 ]
机构
[1] Nagoya City Univ, Grad Sch Med Sci, Dept Ophthalmol & Visual Sci, Nagoya, Aichi 4678602, Japan
[2] Nagoya Univ, Grad Sch Med, Dept Ophthalmol, Nagoya, Aichi 4648601, Japan
[3] Osaka Univ, Grad Sch Med, Dept Ophthalmol, Osaka, Japan
[4] Nihon Univ, Sch Med, Dept Ophthalmol, Tokyo, Japan
[5] Tokyo Womens Med Univ, Dept Ophthalmol, Tokyo, Japan
[6] Juntendo Univ, Urayasu Hosp, Dept Ophthalmol, Chiba, Japan
[7] Bayer Yakuhin Ltd, Osaka, Japan
[8] Bayer HealthCare Pharmaceut, Berlin, Germany
[9] Med Univ Vienna, Dept Ophthalmol & Optometry, Vienna, Austria
[10] Med Univ Vienna, Vienna Reading Ctr VRC, Vienna, Austria
[11] Univ Oxford, Oxford Eye Hosp, Oxford, England
关键词
POLYPOIDAL CHOROIDAL VASCULOPATHY; EXTEND-I; RANIBIZUMAB; NEOVASCULARIZATION; BEVACIZUMAB; POPULATION; PREVALENCE; EYE;
D O I
10.1136/bjophthalmol-2014-305076
中图分类号
R77 [眼科学];
学科分类号
100212 ;
摘要
Background/aims To evaluate efficacy and safety of intravitreal aflibercept (IVT-AFL) in Japanese patients with wet age-related macular degeneration (wAMD) from the VIEW 2 trial. Methods In this double-masked study, patients were randomised to: 0.5 mg IVT-AFL every 4 weeks (0.5q4); 2 mg IVT-AFL every 4 weeks (2q4); 2 mg IVT-AFL every 8 weeks (2q8) after 3 monthly injections; or 0.5 mg ranibizumab every 4 weeks (Rq4). Main efficacy outcomes included vision maintenance and best-corrected visual acuity (BCVA) at week 52. Results At week 52, all Japanese patients in the IVTAFL groups (n=70) maintained vision, compared with 96% of Japanese patients (n=23/24) treated with ranibizumab. Japanese patients in all treatment groups showed improvement in BCVA after treatment. The Rq4, 2q4 and 2q8 groups experienced similar gains in BCVA from baseline. The 0.5q4 group had higher gains due to an unexpected drop in BCVA between screening and baseline. Central retinal thickness and mean area of choroidal neovascularisation decreased in all treatment groups with similar magnitude. Ocular treatment-emergent adverse events were balanced across treatment groups. Conclusions IVT-AFL was effective and well tolerated in Japanese patients. Outcomes in this population were consistent with those in the overall VIEW 2 population.
引用
收藏
页码:92 / 97
页数:6
相关论文
共 17 条
[1]   Towards an understanding of age-related macular disease [J].
Bird, AC .
EYE, 2003, 17 (04) :457-466
[2]   ARMS2 (LOC387715) Variants in Japanese Patients with Exudative Age-related Macular Degeneration and Polypoidal Choroidal Vasculopathy [J].
Gotoh, Norimoto ;
Nakanishi, Hideo ;
Hayashi, Hisako ;
Yamada, Ryo ;
Otani, Atsushi ;
Tsujikawa, Akitaka ;
Yamashiro, Kenji ;
Tamura, Hiroshi ;
Saito, Masaaki ;
Saito, Kuniharu ;
Iida, Tomohiro ;
Matsuda, Fumihiko ;
Yoshimura, Nagahisa .
AMERICAN JOURNAL OF OPHTHALMOLOGY, 2009, 147 (06) :1037-1041
[3]   CFH and ARMS2 Variations in Age-Related Macular Degeneration, Polypoidal Choroidal Vasculopathy, and Retinal Angiomatous Proliferation [J].
Hayashi, Hisako ;
Yamashiro, Kenji ;
Gotoh, Norimoto ;
Nakanishi, Hideo ;
Nakata, Isao ;
Tsujikawa, Akitaka ;
Otani, Atsushi ;
Saito, Masaaki ;
Iida, Tomohiro ;
Matsuo, Keitaro ;
Tajima, Kazuo ;
Yamada, Ryo ;
Yoshimura, Nagahisa .
INVESTIGATIVE OPHTHALMOLOGY & VISUAL SCIENCE, 2010, 51 (11) :5914-5919
[4]   Intravitreal Aflibercept (VEGF Trap-Eye) in Wet Age-related Macular Degeneration [J].
Heier, Jeffrey S. ;
Brown, David M. ;
Chong, Victor ;
Korobelnik, Jean-Francois ;
Kaiser, Peter K. ;
Quan Dong Nguyen ;
Kirchhof, Bernd ;
Ho, Allen ;
Ogura, Yuichiro ;
Yancopoulos, George D. ;
Stahl, Neil ;
Vitti, Robert ;
Berliner, Alyson J. ;
Soo, Yuhwen ;
Anderesi, Majid ;
Groetzbach, Georg ;
Sommerauer, Bernd ;
Sandbrink, Rupert ;
Simader, Christian ;
Schmidt-Erfurth, Ursula .
OPHTHALMOLOGY, 2012, 119 (12) :2537-2548
[5]   Prevalence and risk factors for age-related macular degeneration in an adult Japanese population [J].
Kawasaki, Ryo ;
Wang, Jie Jin ;
Ji, Gui-jin ;
Taylor, Bronwen ;
Oizumi, Toshihide ;
Daimon, Makoto ;
Kato, Takeo ;
Kawata, Sumio ;
Kayama, Takamasa ;
Tano, Yasuo ;
Mitchell, Paul ;
Yamashita, Hidetoshi ;
Wong, Tien Yin .
OPHTHALMOLOGY, 2008, 115 (08) :1376-1381
[6]   Is Bilateral Age-related Macular Degeneration Less Common in Asians than Caucasians? [J].
Kawasaki, Ryo ;
Wang, Jie Jin ;
Amirul, F. M. Amirul ;
Rochtchina, Elena ;
Aung, Tin ;
Saw, Seang Mei ;
Mitchell, Paul ;
Wong, Tien Yin .
OPHTHALMIC EPIDEMIOLOGY, 2011, 18 (06) :253-258
[7]   Age-related macular degeneration [J].
Lim, Laurence S. ;
Mitchell, Paul ;
Seddon, Johanna M. ;
Holz, Frank G. ;
Wong, Tien Y. .
LANCET, 2012, 379 (9827) :1728-1738
[8]   Clinical characteristics of exudative age-related macular degeneration in Japanese patients [J].
Maruko, Ichiro ;
Iida, Tomohiro ;
Saito, Masaaki ;
Nagayama, Dai ;
Saito, Kuniharu .
AMERICAN JOURNAL OF OPHTHALMOLOGY, 2007, 144 (01) :15-22
[9]   Effectiveness of intravitreal ranibizumab in exudative age-related macular degeneration (AMD): comparison between typical neovascular AMD and polypoidal choroidal vasculopathy over a 1 year follow-up [J].
Matsumiya, Wataru ;
Honda, Shigeru ;
Kusuhara, Sentaro ;
Tsukahara, Yasutomo ;
Negi, Akira .
BMC OPHTHALMOLOGY, 2013, 13
[10]   Phenotype and Genotype Characteristics of Age-related Macular Degeneration in a Japanese Population [J].
Mori, Keisuke ;
Horie-Inoue, Kuniko ;
Gehlbach, Peter L. ;
Takita, Hiroyasu ;
Kabasawa, Sho ;
Kawasaki, Izumi ;
Ohkubo, Tomoko ;
Kurihara, Susumu ;
Iizuka, Hiroyuki ;
Miyashita, Yumi ;
Katayama, Shigehiro ;
Awata, Takuya ;
Yoneya, Shin ;
Inoue, Satoshi .
OPHTHALMOLOGY, 2010, 117 (05) :928-938