Abstract | BACKGROUND: METHODS: RESULTS: We enrolled 150 infants (total sample of 300 eyes); 143 infants survived to 54 weeks' postmenstrual age, and the 7 infants who died were not included in the primary-outcome analyses. Retinopathy of prematurity recurred in 4 infants in the bevacizumab group (6 of 140 eyes [4%]) and 19 infants in the laser-therapy group (32 of 146 eyes [22%], P=0.002). A significant treatment effect was found for zone I retinopathy of prematurity (P=0.003) but not for zone II disease (P=0.27). CONCLUSIONS: Intravitreal bevacizumab monotherapy, as compared with conventional laser therapy, in infants with stage 3+ retinopathy of prematurity showed a significant benefit for zone I but not zone II disease. Development of peripheral retinal vessels continued after treatment with intravitreal bevacizumab, but conventional laser therapy led to permanent destruction of the peripheral retina. This trial was too small to assess safety. (Funded by Research to Prevent Blindness and others; ClinicalTrials.gov number, NCT00622726.).
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Authors | Helen A Mintz-Hittner, Kathleen A Kennedy, Alice Z Chuang, BEAT-ROP Cooperative Group |
Journal | The New England journal of medicine
(N Engl J Med)
Vol. 364
Issue 7
Pg. 603-15
(Feb 17 2011)
ISSN: 1533-4406 [Electronic] United States |
PMID | 21323540
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
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Chemical References |
- Angiogenesis Inhibitors
- Antibodies, Monoclonal
- Antibodies, Monoclonal, Humanized
- Bevacizumab
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Topics |
- Angiogenesis Inhibitors
(adverse effects, therapeutic use)
- Antibodies, Monoclonal
(adverse effects, therapeutic use)
- Antibodies, Monoclonal, Humanized
- Bevacizumab
- Female
- Humans
- Infant, Newborn
- Infant, Premature
- Intravitreal Injections
- Laser Therapy
(adverse effects)
- Male
- Prospective Studies
- Recurrence
- Retina
(drug effects, pathology)
- Retinal Vessels
- Retinopathy of Prematurity
(classification, drug therapy, therapy)
- Severity of Illness Index
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