| Ranibizumab for neovascular age-related macular degeneration. | |
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MedLine Citation:
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PMID: 17021318 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: Ranibizumab--a recombinant, humanized, monoclonal antibody Fab that neutralizes all active forms of vascular endothelial growth factor A--has been evaluated for the treatment of neovascular age-related macular degeneration. METHODS: In this multicenter, 2-year, double-blind, sham-controlled study, we randomly assigned patients with age-related macular degeneration with either minimally classic or occult (with no classic lesions) choroidal neovascularization to receive 24 monthly intravitreal injections of ranibizumab (either 0.3 mg or 0.5 mg) or sham injections. The primary end point was the proportion of patients losing fewer than 15 letters from baseline visual acuity at 12 months. RESULTS: We enrolled 716 patients in the study. At 12 months, 94.5% of the group given 0.3 mg of ranibizumab and 94.6% of those given 0.5 mg lost fewer than 15 letters, as compared with 62.2% of patients receiving sham injections (P<0.001 for both comparisons). Visual acuity improved by 15 or more letters in 24.8% of the 0.3-mg group and 33.8% of the 0.5-mg group, as compared with 5.0% of the sham-injection group (P<0.001 for both doses). Mean increases in visual acuity were 6.5 letters in the 0.3-mg group and 7.2 letters in the 0.5-mg group, as compared with a decrease of 10.4 letters in the sham-injection group (P<0.001 for both comparisons). The benefit in visual acuity was maintained at 24 months. During 24 months, presumed endophthalmitis was identified in five patients (1.0%) and serious uveitis in six patients (1.3%) given ranibizumab. CONCLUSIONS: Intravitreal administration of ranibizumab for 2 years prevented vision loss and improved mean visual acuity, with low rates of serious adverse events, in patients with minimally classic or occult (with no classic lesions) choroidal neovascularization secondary to age-related macular degeneration. (ClinicalTrials.gov number, NCT00056836 [ClinicalTrials.gov].). |
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Authors:
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Philip J Rosenfeld; David M Brown; Jeffrey S Heier; David S Boyer; Peter K Kaiser; Carol Y Chung; Robert Y Kim; |
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Publication Detail:
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Type: Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: The New England journal of medicine Volume: 355 ISSN: 1533-4406 ISO Abbreviation: N. Engl. J. Med. Publication Date: 2006 Oct |
Date Detail:
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Created Date: 2006-10-05 Completed Date: 2006-10-18 Revised Date: 2007-02-22 |
Medline Journal Info:
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Nlm Unique ID: 0255562 Medline TA: N Engl J Med Country: United States |
Other Details:
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Languages: eng Pagination: 1419-31 Citation Subset: AIM; IM |
Copyright Information:
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Copyright 2006 Massachusetts Medical Society. |
Affiliation:
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Bascom Palmer Eye Institute, Department of Ophthalmology, University of Miami Miller School of Medicine, Miami, FL 33136, USA. prosenfeld@med.miami.edu |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00056836 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Aged Aged, 80 and over Angiogenesis Inhibitors / administration & dosage, adverse effects, therapeutic use* Antibodies, Monoclonal / administration & dosage, adverse effects, therapeutic use* Choroidal Neovascularization / drug therapy Double-Blind Method Female Humans Injections Macular Degeneration / drug therapy*, pathology Male Middle Aged Optic Disk / pathology Visual Acuity / drug effects |
| Chemical | |
Reg. No./Substance:
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0/Angiogenesis Inhibitors; 0/Antibodies, Monoclonal; 0/ranibizumab |
| Comments/Corrections | |
Comment In:
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N Engl J Med. 2006 Oct 5;355(14):1409-12
[PMID:
17021315
]
N Engl J Med. 2007 Feb 15;356(7):748-9; author reply 749-50 [PMID: 17310523 ] N Engl J Med. 2007 Feb 15;356(7):747-8; author reply 749-50 [PMID: 17301310 ] N Engl J Med. 2006 Oct 5;355(14):1493-5 [PMID: 17021326 ] |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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