An analysis of ranibizumab treatment and visual outcomes in real-world settings: the UNCOVER study

被引:11
作者
Eldem, Bora [1 ]
Lai, Timothy Y. Y. [2 ]
Ngah, Nor Fariza [3 ]
Vote, Brendan [4 ]
Yu, Hyeong Gon [5 ]
Fabre, Alban [6 ]
Backer, Arthur [7 ]
Clunas, Nathan J. [7 ]
机构
[1] Hacettepe Univ, Dept Ophthalmol, Sch Med, TR-06100 Ankara, Samanpazari, Turkey
[2] Chinese Univ Hong Kong, Dept Ophthalmol & Visual Sci, Hong Kong, Hong Kong, Peoples R China
[3] Hosp Selayang, Dept Ophthalmol, Selayang, Selangor, Malaysia
[4] Launceston Eye Inst, South Launceston, Australia
[5] Seoul Natl Univ, Dept Ophthalmol, Coll Med, Seoul, South Korea
[6] IQVIA, Barcelona, Spain
[7] Novartis Pharma AG, Basel, Switzerland
关键词
Observational study; Ranibizumab; Visual acuity; Tomography; Optical coherence; AGE-RELATED MACULOPATHY; 2.0 MG RANIBIZUMAB; MACULAR DEGENERATION; EXTEND PROTOCOL; EFFICACY; SAFETY; PREVALENCE; REGIMEN; TRIALS;
D O I
10.1007/s00417-017-3890-8
中图分类号
R77 [眼科学];
学科分类号
100212 ;
摘要
To describe intravitreal ranibizumab treatment frequency, clinical monitoring, and visual outcomes (including mean central retinal thickness [CRT] and visual acuity [VA] changes from baseline) in neovascular age-related macular degeneration (nAMD) in real-world settings across three ranibizumab reimbursement scenarios in the Middle East, North Africa, and the Asia-Pacific region. Non-interventional multicenter historical cohort study of intravitreal ranibizumab use for nAMD in routine clinical practice between April 2010 and April 2013. Eligible patients were diagnosed with nAMD, received at least one intravitreal ranibizumab injection during the study period, and had been observed for a minimum of 1 year (up to 3 years). Reimbursement scenarios were defined as self-paid, partially-reimbursed, and fully-reimbursed. More than three-fourths (n = 2521) of the analysis population was partially-reimbursed for ranibizumab, while 16.4% (n = 532) was fully-reimbursed, and 5.8% was self-paid (n = 188). The average annual ranibizumab injection frequency was 4.1 injections in the partially-reimbursed, 4.7 in the fully-reimbursed and 2.6 in the self-paid populations. The average clinical monitoring frequency was estimated to be 6.7 visits/year, with similar frequencies observed across reimbursement categories. On average, patients experienced VA reduction of -0.7 letters and a decrease in CRT of -44.4 mu m. The greatest mean CRT change was observed in the self-paid group, with -92.6 mu m. UNCOVER included a large, heterogeneous ranibizumab-treated nAMD population in real-world settings. Patients in all reimbursement scenarios attained vision stability on average, indicating control of disease activity.
引用
收藏
页码:963 / 973
页数:11
相关论文
共 24 条
[1]   ANTI-VEGF TREATMENT IN NEOVASCULAR AGE-RELATED MACULAR DEGENERATION A Treat-and-Extend Protocol Over 2 Years [J].
Abedi, Farshad ;
Wickremasinghe, Sanjeewa ;
Islam, Amirul F. M. ;
Inglis, Kellie M. ;
Guymer, Robyn H. .
RETINA-THE JOURNAL OF RETINAL AND VITREOUS DISEASES, 2014, 34 (08) :1531-1538
[2]   Comparison of Ranibizumab and Bevacizumab for Neovascular Age-Related Macular Degeneration According to LUCAS Treat-and-Extend Protocol [J].
Berg, Karina ;
Pedersen, Terje R. ;
Sandvik, Leiv ;
Bragadottir, Ragnheidur .
OPHTHALMOLOGY, 2015, 122 (01) :146-152
[3]   SUBMACULAR SURGERY - ARE RANDOMIZED TRIALS NECESSARY [J].
BRESSLER, NM .
ARCHIVES OF OPHTHALMOLOGY, 1995, 113 (12) :1557-1560
[4]   Ranibizumab versus verteporfin for neovascular age-related macular degeneration [J].
Brown, David M. ;
Kaiser, Peter K. ;
Michels, Mark ;
Soubrane, Gisele ;
Heier, Jeffrey S. ;
Kim, Robert Y. ;
Sy, Judy P. ;
Schneider, Susan .
NEW ENGLAND JOURNAL OF MEDICINE, 2006, 355 (14) :1432-1444
[5]   Twelve-Month Efficacy and Safety of 0.5 mg or 2.0 mg Ranibizumab in Patients with Subfoveal Neovascular Age-related Macular Degeneration [J].
Busbee, Brandon G. ;
Ho, Allen C. ;
Brown, David M. ;
Heier, Jeffrey S. ;
Suner, Ivan J. ;
Li, Zhengrong ;
Rubio, Roman G. ;
Lai, Phillip .
OPHTHALMOLOGY, 2013, 120 (05) :1046-1056
[6]   Alternative treatments to inhibit VEGF in age-related choroidal neovascularisation: 2-year findings of the IVAN randomised controlled trial [J].
Chakravarthy, Usha ;
Harding, Simon P. ;
Rogers, Chris A. ;
Downes, Susan M. ;
Lotery, Andrew J. ;
Culliford, Lucy A. ;
Reeves, Barnaby C. .
LANCET, 2013, 382 (9900) :1258-1267
[7]   Ranibizumab for the treatment of wet AMD: a summary of real-world studies (vol 30, pg 270, 2016) [J].
Chong, V. .
EYE, 2016, 30 (11) :1526-1526
[8]   Comparison of two intravitreal ranibizumab treatment schedules for neovascular age-related macular degeneration [J].
Gupta, Bhaskar ;
Adewoyin, Temilade ;
Patel, Sheryl-Kay ;
Sivaprasad, Sobha .
BRITISH JOURNAL OF OPHTHALMOLOGY, 2011, 95 (03) :386-390
[9]   Polypoidal choroidal vasculopathy in Caucasian patients with presumed neovascular age-related macular degeneration and poor ranibizumab response [J].
Hatz, Katja ;
Pruente, Christian .
BRITISH JOURNAL OF OPHTHALMOLOGY, 2014, 98 (02) :188-194
[10]   Twenty-four-Month Efficacy and Safety of 0.5 mg or 2.0 mg Ranibizumab in Patients with Subfoveal Neovascular Age-Related Macular Degeneration [J].
Ho, Allen C. ;
Busbee, Brandon G. ;
Regillo, Carl D. ;
Wieland, Mark R. ;
Van Everen, Sherri A. ;
Li, Zhengrong ;
Rubio, Roman G. ;
Lai, Phillip .
OPHTHALMOLOGY, 2014, 121 (11) :2181-2192