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Ranibizumab for Edema of the Macula in Diabetes Study: 3-Year Outcomes and the Need for Prolonged Frequent Treatment

yucloud 添加于 2012-10-18 09:37 | 1582 次阅读 | 0 个评论

作者
Do DV, Nguyen QD, Khwaja AA, Channa R, Sepah YJ, Sophie R, Hafiz G, Campochiaro PA
摘要
OBJECTIVE To assess the benefit of increased follow-up and treatment with ranibizumab between months 24 and 36 in the Ranibizumab for Edema of the Macula in Diabetes (READ-2) Study. DESIGN Prospective, interventional, multicenter follow-up of a randomized clinical trial. METHODS Patients who agreed to participate between months 24 and 36 (ranibizumab, 28 patients; laser, 22; and ranibizumab + laser, 24) returned monthly and received ranibizumab, 0.5 mg, if foveal thickness (FTH, center subfield thickness) was 250 mum or greater. Main outcome measures were improvement in best-corrected visual acuity (BCVA) and reduction in FTH between months 24 and 36. RESULTS Mean improvement from the baseline BCVA in the ranibizumab group was 10.3 letters at month 36 vs 7.2 letters at month 24 (DeltaBCVA letters = 3.1, P = .009), and FTH at month 36 was 282 mum vs 352 mum at month 24 (DeltaFTH = 70 mum, P = .006). Changes in BCVA and FTH in the laser group (-1.6 letters and -36 mum, respectively) and the ranibizumab + laser group (+2.0 letters and -24 mum) were not statistically significant. The mean number of ranibizumab injections was significantly greater in the ranibizumab group compared with the laser group (5.4 vs 2.3 injections, P = .008) but not compared with the ranibizumab + laser group (3.3, P = .11). CONCLUSIONS More aggressive treatment with ranibizumab during year 3 resulted in a reduction in mean FTH and improvement in BCVA in the ranibizumab group. More extensive focal/grid laser therapy in the other 2 groups may have reduced the need for more frequent ranibizumab injections to control edema. APPLICATION TO CLINICAL PRACTICE Long-term visual outcomes for treatment of diabetic macular edema with ranibizumab are excellent, but many patients require frequent injections to optimally control edema and maximize vision. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00407381.
详细资料
- 文献种类: Journal Article
- 期刊名称: Archives of Ophthalmology
- 期刊缩写: Arch Ophthalmol
- 期卷页: 2012年 1-7页
- ISBN: 0003-9950
学科领域生物医药 » 药学
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