Document Detail


Bevacizumab for neovascular age-related macular degeneration in China.
MedLine Citation:
PMID:  22818896     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: To evaluate 2 different dosing regimens of intravitreal bevacizumab for the treatment of neovascular age-related macular degeneration (AMD) patients in China.
DESIGN: Multicenter, randomized, prospective, open-label clinical trial.
PARTICIPANTS: One hundred eighty-five patients with active neovascular AMD, exclusion of a macular scar, choroidal neovascularization not resulting from AMD, and polypoidal choroidal vasculopathy.
INTERVENTION: Patients were assigned randomly to receive intravitreal injections of bevacizumab every 6 weeks for the first 3 injections followed by injections every 6 weeks (regimen A, n = 91) or every 12 weeks (regimen B, n = 94).
MAIN OUTCOME MEASURES: The primary outcome measure was a comparison of the mean change in visual acuity from baseline. The secondary outcome measure was a comparison of the proportion of patients with a change in visual acuity of 15 letters or more. Adverse events were monitored.
RESULTS: One-hundred eighty five patients were enrolled. At 48 weeks, the increase in the mean visual acuity measurements from baseline were 12.58 letters in regimen A and 10.06 letters in regimen B (P = 0.288). At 48 weeks, the percentage of eyes losing fewer than 15 letters was 96.2% in regimen A and 93.9% in regimen B (P = 0.720). At 48 weeks, the median decrease in central retinal thickness measurements from baseline was 119 μm in regimen A and 60 μm in regimen B (P = 0.221). Adverse events during the 48 weeks included anterior chamber inflammation in 17 patients (18.7%) from regimen A and 9 patients (9.6%) from regimen B (P = 0.075). There were no other notable ocular adverse events in either group.
CONCLUSIONS: Intravitreal bevacizumab improved visual acuity and decreased macular thickness in patients with neovascular AMD when dosed either every 6 weeks or every 12 weeks after 3 doses given at 6-week intervals. Although there were no statistically significant differences between the 2 regimens, the results tended to favor the group dosed every 6 weeks (regimen A).
Authors:
Xiaoxin Li; Yonghua Hu; Xiaodong Sun; Junjun Zhang; Maonian Zhang;
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2012-07-20
Journal Detail:
Title:  Ophthalmology     Volume:  119     ISSN:  1549-4713     ISO Abbreviation:  Ophthalmology     Publication Date:  2012 Oct 
Date Detail:
Created Date:  2012-10-04     Completed Date:  2012-12-19     Revised Date:  2013-05-27    
Medline Journal Info:
Nlm Unique ID:  7802443     Medline TA:  Ophthalmology     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2087-93     Citation Subset:  IM    
Copyright Information:
Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
Affiliation:
Department of Ophthalmology, People's Hospital, Peking University, Beijing, China. dr_lixiaoxin@163.com
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT01306591
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MeSH Terms
Descriptor/Qualifier:
Aged
Aged, 80 and over
Angiogenesis Inhibitors / administration & dosage*,  adverse effects
Antibodies, Monoclonal, Humanized / administration & dosage*,  adverse effects
China / epidemiology
Coloring Agents / diagnostic use
Female
Fluorescein Angiography
Humans
Indocyanine Green / diagnostic use
Intraocular Pressure
Intravitreal Injections
Male
Middle Aged
Prospective Studies
Retina / drug effects,  pathology
Time Factors
Tomography, Optical Coherence
Treatment Outcome
Vascular Endothelial Growth Factor A / antagonists & inhibitors
Visual Acuity / drug effects,  physiology
Wet Macular Degeneration / drug therapy*,  ethnology,  physiopathology
Chemical
Reg. No./Substance:
0/Angiogenesis Inhibitors; 0/Antibodies, Monoclonal, Humanized; 0/Coloring Agents; 0/VEGFA protein, human; 0/Vascular Endothelial Growth Factor A; 2S9ZZM9Q9V/bevacizumab; 3599-32-4/Indocyanine Green

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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