Document Detail


Bevacizumab for macular edema in central retinal vein occlusion: a prospective, randomized, double-masked clinical study.
MedLine Citation:
PMID:  22424833     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
PURPOSE: To evaluate the efficacy of intraocular injections with bevacizumab in patients with macular edema (ME) secondary to central retinal vein occlusion (CRVO).
DESIGN: Prospective, randomized, sham injection-controlled, double-masked clinical trial.
PARTICIPANTS: Sixty patients with ME secondary to CRVO.
METHODS: At baseline, patients were randomized 1:1 to receive intraocular injections of bevacizumab or sham injections every 6 weeks for 6 months.
MAIN OUTCOME MEASURES: The primary outcome measure was the proportion of patients gaining at least 15 letters at 6 months. Secondary outcome measures included mean change from baseline best-corrected visual acuity (BCVA), foveal thickness, and neovascular glaucoma.
RESULTS: At the end of follow-up, 18 of 30 patients (60.0%) in the study group had gained ≥15 letters compared with 6 of 30 patients (20.0%) in the control group (P=0.003). The BCVA improved by 14.1 letters at 24 weeks compared with a decrease of 2.0 letters in the control group (P < 0.003). The mean decrease in central retinal thickness (CRT) was significantly greater in the study group (426 μm) than in the control group (102 μm) at all time points up to week 24 (P < 0.001). No residual edema, defined as CRT <300 μm at 24 weeks, was found in 26 of 30 patients (86.7%) in the treatment group compared with 6 of 30 patients (20%) in the control group (P < 0.001). In the sham group, 5 of 30 patients (16.7%) had developed iris rubeosis at week 24. No patients in the study group had rubeosis at week 24 (P=0.052). There were no events of endophthalmitis, retinal tear, or retinal detachment during the 24-week treatment period. No serious non-ocular adverse events were reported.
CONCLUSIONS: Intraocular injections of bevacizumab given every 6 weeks for 6 months improve visual acuity (VA) and reduce ME significantly compared with sham.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.
Authors:
David L J Epstein; Peep V Algvere; Gunvor von Wendt; Stefan Seregard; Anders Kvanta
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial     Date:  2012-03-17
Journal Detail:
Title:  Ophthalmology     Volume:  119     ISSN:  1549-4713     ISO Abbreviation:  Ophthalmology     Publication Date:  2012 Jun 
Date Detail:
Created Date:  2012-06-04     Completed Date:  2012-08-22     Revised Date:  2013-05-27    
Medline Journal Info:
Nlm Unique ID:  7802443     Medline TA:  Ophthalmology     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1184-9     Citation Subset:  IM    
Copyright Information:
Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
Affiliation:
Department of Ophthalmology, Karolinska Institutet, St. Eriks Eye Hospital, Stockholm, Sweden. david.epstein@sankterik.se
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MeSH Terms
Descriptor/Qualifier:
Aged
Aged, 80 and over
Angiogenesis Inhibitors / administration & dosage,  therapeutic use*
Antibodies, Monoclonal, Humanized / administration & dosage,  therapeutic use*
Double-Blind Method
Female
Follow-Up Studies
Humans
Intravitreal Injections
Macular Edema / drug therapy*,  etiology,  physiopathology
Male
Middle Aged
Prospective Studies
Retinal Vein Occlusion / complications,  drug therapy*,  physiopathology
Tomography, Optical Coherence
Treatment Outcome
Vascular Endothelial Growth Factor A / antagonists & inhibitors
Visual Acuity / physiology
Chemical
Reg. No./Substance:
0/Angiogenesis Inhibitors; 0/Antibodies, Monoclonal, Humanized; 0/VEGFA protein, human; 0/Vascular Endothelial Growth Factor A; 2S9ZZM9Q9V/bevacizumab

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