RANIBIZUMAB TREATMENT IN TREATMENT-NAIVE NEOVASCULAR AGE-RELATED MACULAR DEGENERATION Results From LUMINOUS, a Global Real-World Study

被引:78
作者
Holz, Frank G. [1 ]
Figueroa, Marta S. [2 ]
Bandello, Francesco [3 ]
Yang, Yit [4 ,5 ]
Ohji, Masahito [6 ]
Dai, Hong [7 ]
Wykrota, Halina [8 ]
Sharma, Sanjay [9 ]
Dunger-Baldauf, Cornelia [10 ]
Lacey, Sue [11 ]
Macfadden, Wayne [10 ]
Mitchell, Paul [12 ,13 ]
机构
[1] Univ Bonn, Dept Ophthalmol, Ernst Abbe Str 2, D-53127 Bonn, Germany
[2] Ramon Y Cajal Univ Hosp, Dept Ophthalmol, Madrid, Spain
[3] Univ Vita Salute, Sci Inst San Raffaele, Dept Ophthalmol, Milan, Italy
[4] Wolverhampton Eye Infirm, Dept Ophthalmol, Wolverhampton, England
[5] Aston Univ, Sch Hlth & Life Sci, Dept Ophthalmol, Birmingham, W Midlands, England
[6] Shiga Univ Med Sci, Dept Ophthalmol, Otsu, Shiga, Japan
[7] Beijing Hosp, Natl Ctr Gerontol, Dept Ophthalmol, Beijing, Peoples R China
[8] I Klin Okulistyki Slaskiej Akad Med, Dept Ophthalmol, Katowicach, Poland
[9] Queens Univ, Dept Ophthalmol & Epidemiol, Kingston, ON, Canada
[10] Novartis Pharma AG, Dept Ophthalmol, Basel, Switzerland
[11] Novartis Pharmaceut UK Ltd, Dept Ophthalmol, Frimley, Camberley, England
[12] Univ Sydney, Ctr Vis Res, Dept Ophthalmol, Sydney, NSW, Australia
[13] Univ Sydney, Westmead Inst Med Res, Sydney, NSW, Australia
来源
RETINA-THE JOURNAL OF RETINAL AND VITREOUS DISEASES | 2020年 / 40卷 / 09期
关键词
anti-VEGF therapy; LUMINOUS; effectiveness; neovascular age-related macular degeneration; ranibizumab; observational study; real-world; treatment-naive; visual acuity; VISUAL-ACUITY; INTRAVITREAL RANIBIZUMAB; STABILIZATION CRITERIA; TREATMENT PATTERNS; 12-MONTH OUTCOMES; CLINICAL-PRACTICE; EXTEND REGIMEN; 0.5; MG; PREVALENCE; THERAPY;
D O I
10.1097/IAE.0000000000002670
中图分类号
R77 [眼科学];
学科分类号
100212 ;
摘要
Purpose: To evaluate the effectiveness, safety, and treatment patterns of ranibizumab 0.5 mg in treatment-naive patients with neovascular age-related macular degeneration enrolled in LUMINOUS study. Methods: This 5-year, prospective, multicenter, observational study recruited 30,138 adult patients (treatment-naive or previously treated with ranibizumab or other ocular treatments) who were treated according to the local ranibizumab label. Results: Six thousand two hundred and forty-one treatment-naive neovascular age-related macular degeneration patients were recruited. Baseline (BL) demographics were, mean (SD) age 75.0 (10.2) years, 54.9% females, and 66.5% Caucasian. The mean (SD) visual acuity (VA; letters) gain at 1 year was 3.1 (16.51) (n = 3,379; BLVA, 51.9 letters [Snellen: 20/92]) with a mean (SD) of 5.0 (2.7) injections and 8.8 (3.3) monitoring visits. Presented by injection frequencies <3 (n = 537), 3 to 6 (n = 1,924), and >6 (n = 918), visual acuity gains were 1.6 (14.93), 3.3 (16.57), and 3.7 (17.21) letters, respectively. Stratified by BLVA <23 (n = 382), 23 to <39 (n = 559), 39 to <60 (n = 929), 60 to <74 (n = 994), and >= 74 (n = 515), visual acuity change was 12.6 (20.63), 6.7 (17.88), 3.6 (16.41), 0.3 (13.83), and -3.0 (11.82) letters, respectively. The incidence of ocular/nonocular adverse events was 8.2%/12.8% and serious adverse events were 0.9%/7.4%, respectively. Conclusion: These results demonstrate the effectiveness and safety of ranibizumab in treatment-naive neovascular age-related macular degeneration patients.
引用
收藏
页码:1673 / 1685
页数:13
相关论文
共 52 条
[1]  
[Anonymous], 2017, Business Wire
[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]   Vision-related quality of life in patients receiving intravitreal ranibizumab injections in routine clinical practice: baseline data from the German OCEAN study [J].
Bertelmann, Thomas ;
Feltgen, Nicolas ;
Scheffler, Martin ;
Hufenbach, Ulrich ;
Wiedon, Annette ;
Wilhelm, Helmut ;
Ziemssen, Focke .
HEALTH AND QUALITY OF LIFE OUTCOMES, 2016, 14
[4]  
Bressler Neil M, 2004, JAMA, V291, P1900, DOI 10.1001/jama.291.15.1900
[5]   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
[6]   Sustained Benefits from Ranibizumab for Macular Edema Following Branch Retinal Vein Occlusion: 12-Month Outcomes of a Phase III Study [J].
Brown, David M. ;
Campochiaro, Peter A. ;
Bhisitkul, Robert B. ;
Ho, Allen C. ;
Gray, Sarah ;
Saroj, Namrata ;
Adamis, Anthony P. ;
Rubio, Roman G. ;
Murahashi, Wendy Yee .
OPHTHALMOLOGY, 2011, 118 (08) :1594-1602
[7]   Ranibizumab versus Verteporfin Photodynamic Therapy for Neovascular Age-Related Macular Degeneration: Two-Year Results of the ANCHOR Study [J].
Brown, David M. ;
Michels, Mark ;
Kaiser, Peter K. ;
Heier, Jeffrey S. ;
Sy, Judy P. ;
Ianchulev, Tsontcho .
OPHTHALMOLOGY, 2009, 116 (01) :57-65
[8]   Long-term Outcomes in Patients with Retinal Vein Occlusion Treated with Ranibizumab The RETAIN Study [J].
Campochiaro, Peter A. ;
Sophie, Raafay ;
Pearlman, Joel ;
Brown, David M. ;
Boyer, David S. ;
Heier, Jeffrey S. ;
Marcus, Dennis M. ;
Feiner, Leonard ;
Patel, Arun .
OPHTHALMOLOGY, 2014, 121 (01) :209-219
[9]   Ranibizumab for the treatment of wet AMD: a summary of real-world studies [J].
Chong, V. .
EYE, 2016, 30 (02) :270-286
[10]  
ClinicalTrials.gov, OBS EFF SAF RAN REAL