Document Detail

Benefit from bevacizumab for macular edema in central retinal vein occlusion: twelve-month results of a prospective, randomized study.
MedLine Citation:
PMID:  22902212     Owner:  NLM     Status:  MEDLINE    
PURPOSE: To evaluate the efficacy of intraocular injections with bevacizumab over 12 months in patients with macular edema (ME) secondary to central retinal vein occlusion (CRVO).
DESIGN: A prospective study including a randomized 6-month, sham injection-controlled, double-masked clinical trial followed by a 6-month open-label extension.
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. From month 6, all patients received intraocular injections of bevacizumab every 6 weeks for 6 months.
MAIN OUTCOME MEASURES: The primary outcome measure was the proportion of patients gaining at least 15 letters at 12 months. Secondary outcome measures included mean change from baseline best-corrected visual acuity (BCVA), change in foveal thickness, and development of neovascular glaucoma.
RESULTS: At the end of follow-up, 18 of 30 patients (60.0%) in the bevacizumab/bevacizumab (bz/bz) group had gained ≥ 15 letters compared with 10 of 30 patients (33.3%) in the sham/bevacizumab (sh/bz) group (P < 0.05). The BCVA improved by 16.0 letters at 12 months in the bz/bz group compared with 4.6 letters in the sh/bz group (P < 0.05). In an unplanned retrospective analysis, patients aged >70 years had a significantly worse outcome when receiving delayed treatment, losing 1.4 letters (95% confidence interval [CI], -9.7 to 8.4) in the sh/bz group compared with a gain of 20.1 letters (95% CI, 13.9-26.3) in the bz/bz group in patients aged <70 years (P < 0.003). The mean decrease in central retinal thickness (CRT) was 435 μm in the bz/bz group compared with 404 μm in the sh/bz group (P = not significant). No patients developed iris rubeosis during the 6-month open-label extension period. There were no events of endophthalmitis, retinal tear, or retinal detachment during the 12-month treatment period. No serious nonocular adverse events were reported.
CONCLUSIONS: Intraocular injections of bevacizumab given every 6 weeks for 12 months improve visual acuity (VA) and reduce ME significantly. Patients receiving delayed treatment have a limited visual improvement.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.
David L Epstein; Peep V Algvere; Gunvor von Wendt; Stefan Seregard; Anders Kvanta
Publication Detail:
Type:  Journal Article; Randomized Controlled Trial     Date:  2012-08-17
Journal Detail:
Title:  Ophthalmology     Volume:  119     ISSN:  1549-4713     ISO Abbreviation:  Ophthalmology     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-12-04     Completed Date:  2013-02-07     Revised Date:  2013-05-27    
Medline Journal Info:
Nlm Unique ID:  7802443     Medline TA:  Ophthalmology     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2587-91     Citation Subset:  IM    
Copyright Information:
Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
Department of Ophthalmology, Karolinska Institutet, St. Eriks Eye Hospital, Stockholm, Sweden.
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MeSH Terms
Angiogenesis Inhibitors / therapeutic use*
Antibodies, Monoclonal, Humanized / therapeutic use*
Double-Blind Method
Intravitreal Injections
Macular Edema / drug therapy*,  etiology,  physiopathology
Prospective Studies
Retinal Vein Occlusion / complications*,  physiopathology
Tomography, Optical Coherence
Treatment Outcome
Vascular Endothelial Growth Factor A / antagonists & inhibitors
Visual Acuity / physiology
Reg. No./Substance:
0/Angiogenesis Inhibitors; 0/Antibodies, Monoclonal, Humanized; 0/VEGFA protein, human; 0/Vascular Endothelial Growth Factor A; 2S9ZZM9Q9V/bevacizumab

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

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