Randomized, Double-Masked, Sham-Controlled Trial of Ranibizumab for Neovascular Age-Related Macular Degeneration: PIER Study Year 2

To evaluate efficacy and safety of quarterly (and then monthly) ranibizumab during the 2-year Phase IIIb, multicenter, randomized, double-masked, sham injection–controlled study of the efficacy and safety of ranibizumab in subjects with subfoveal CNV with or without classic CNV secondary to AMD (PIE...

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Vydáno v:	American journal of ophthalmology Ročník 150; číslo 3; s. 315 - 324.e1
Hlavní autoři:	Abraham, Prema, Yue, Huibin, Wilson, Laura
Médium:	Journal Article
Jazyk:	angličtina
Vydáno:	New York, NY Elsevier Inc 01.09.2010 Elsevier Elsevier Limited
Témata:	Aged Aged, 80 and over Angiogenesis Inhibitors - administration & dosage Angiogenesis Inhibitors - adverse effects Antibodies, Monoclonal - administration & dosage Antibodies, Monoclonal - adverse effects Antibodies, Monoclonal, Humanized Biological and medical sciences Choroidal Neovascularization - drug therapy Choroidal Neovascularization - etiology Choroidal Neovascularization - physiopathology Confidence intervals Cross-Over Studies Diabetic retinopathy Double-Blind Method Female Health Insurance Portability & Accountability Act 1996-US Hemorrhage Humans Injections Macular degeneration Macular Degeneration - complications Macular Degeneration - drug therapy Macular Degeneration - physiopathology Male Medical imaging Medical sciences Middle Aged Miscellaneous Occult sciences Ophthalmology Photodynamic therapy Ranibizumab Retina Retinopathies Retreatment Standard deviation Treatment Outcome Vascular endothelial growth factor Visual Acuity - physiology Vitreous Body South San Francisco California California Immunomodulator Eye disease Retinopathy Vascular endothelium growth factor Ranibizumab Mask Clinical trial Age related macular degeneration Monoclonal antibody Neovascularization Ophthalmology Antiangiogenic agent
ISSN:	0002-9394, 1879-1891, 1879-1891
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Popis
Shrnutí:	To evaluate efficacy and safety of quarterly (and then monthly) ranibizumab during the 2-year Phase IIIb, multicenter, randomized, double-masked, sham injection–controlled study of the efficacy and safety of ranibizumab in subjects with subfoveal CNV with or without classic CNV secondary to AMD (PIER) study. Phase IIIb, multicenter, randomized, double-masked, sham injection–controlled trial in patients with choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). Patients were randomized 1:1:1 to sham injection (n = 63) or 0.3 mg (n = 60) or 0.5 mg (n = 61) intravitreal ranibizumab monthly for 3 months and then quarterly. During study year 2, eligible sham-group patients crossed over to 0.5 mg ranibizumab quarterly. Later in year 2, all eligible randomized patients rolled over to 0.5 mg ranibizumab monthly. Key efficacy and safety outcomes of the 2-year trial are reported. At month 24, visual acuity (VA) had decreased an average of 21.4, 2.2, and 2.3 letters from baseline in the sham, 0.3 mg, and 0.5 mg groups ( P < .0001 for each ranibizumab group vs sham). VA of sham patients who crossed over (and subsequently rolled over) to ranibizumab decreased across time, with an average loss of 3.5 letters 10 months after crossover. VA of 0.3 mg and 0.5 mg group patients who rolled over to monthly ranibizumab increased for an average gain of 2.2 and 4.1 letters, respectively, 4 months after rollover. The ocular safety profile of ranibizumab was favorable and consistent with previous reports. Ranibizumab provided significant VA benefit in patients with AMD-related CNV compared with sham injection. Ranibizumab appeared to provide additional VA benefit to treated patients who rolled over to monthly dosing, but not to patients who began receiving ranibizumab after >14 months of sham injections.
Bibliografie:	ObjectType-Article-2 SourceType-Scholarly Journals-1 content type line 14 ObjectType-Undefined-1 ObjectType-Feature-3 ObjectType-Article-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3
ISSN:	0002-9394 1879-1891 1879-1891
DOI:	10.1016/j.ajo.2010.04.011