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Intravitreal bevacizumab (Avastin) for persistent new vessels in diabetic retinopathy (IBEPE study).

机译:玻璃体内贝伐单抗(Avastin)用于糖尿病性视网膜病变的持续性新血管(IBEPE研究)。

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OBJECTIVE: To evaluate the short-term fluorescein angiographic and visual acuity effects of a single intravitreal injection of bevacizumab (Avastin) for the management of persistent new vessels (NV) associated with diabetic retinopathy. METHODS: A prospective, nonrandomized open-label study of diabetic patients with actively leaking NV refractory to laser treatment and best-corrected Early Treatment Diabetic Retinopathy Study visual acuity (BCVA) worse than 20/40. Standardized ophthalmic evaluation was performed at baseline and at weeks 1, 6, and 12 (+/-1) following intravitreal injection of 1.5 mg of bevacizumab. Main outcome measures include changes in total area of fluorescein leakage from active NV and BCVA. RESULTS: Fifteen consecutive patients (men, 9 [60%]; women, 6 [40%]) were included and all completed the 12-week follow-up period of the study. The mean +/- SD age of participants was 60.08 +/- 7.75 years (median, 59.5; range, 49-73 years). At baseline, mean +/- standard error of the mean (SEM)NV leakage area was 27.79 +/- 6.29 mm2. The mean +/- SEM area of active leaking NV decreased significantly to 5.43 +/- 2.18 mm2 and 5.50 +/- 1.24 mm2 (P < 0.05, Tukey multiple comparisons post-test) at 1 and 12 weeks postinjection, respectively; at week 6 no leakage was observed. The mean +/- SEM logMAR (Snellen equivalent) BCVA improved significantly from 0.90 (20/160) +/- 0.11 at baseline to 0.76 (20/125(+2)) +/- 0.12, 0.77 (20/125(+2)) +/- 0.11, and 0.77 (20/125(+2)) +/- 0.12 at weeks 1, 6, and 12, respectively (P < 0.05, Tukey multiple comparisons post-test). No major adverse events were observed. CONCLUSIONS: Intravitreal injection of bevacizumab achieved short-term reduction of fluorescein leakage from persistent active NV without loss of vision in patients with diabetic retinopathy. Further studies to investigate the role of anti-VEGF therapy with bevacizumab for the management of diabetic retinopathy refractory to laser treatment are warranted.
机译:目的:评估单次玻璃体内注射贝伐单抗(Avastin)的荧光素血管造影和视敏度对糖尿病性视网膜病变相关的持续性新血管(NV)的管理作用。方法:一项前瞻性,非随机开放标签研究,对糖尿病患者进行激光治疗后主动漏出NV,并且经最佳矫正的早期治疗糖尿病性视网膜病研究视力(BCVA)低于20/40。在玻璃体内注射1.5 mg贝伐单抗后,在基线以及第1、6和12周(+/- 1)进行标准化的眼科评估。主要结果指标包括活动NV和BCVA泄漏的荧光素总面积的变化。结果:纳入15例连续患者(男性9例[60%];女性6例[40%]),均完成了研究的12周随访期。参与者的平均+/- SD年龄为60.08 +/- 7.75岁(中位数为59.5;范围为49-73岁)。在基线时,平均(SEM)NV泄漏面积的平均值+/-标准误差为27.79 +/- 6.29 mm2。在注射后1周和12周,主动渗漏型NV的平均+/- SEM面积分别显着下降至5.43 +/- 2.18 mm2和5.50 +/- 1.24 mm2(P <0.05,Tukey多重比较测试后);在第6周,未观察到泄漏。平均+/- SEM logMAR(等效于Snellen的BCVA)从基线时的0.90(20/160)+/- 0.11显着提高到0.76(20/125(+2))+/- 0.12,0.77(20/125(+ 2))在第1、6和12周分别为+/- 0.11和0.77(20/125(+2))+/- 0.12(P <0.05,测试后Tukey多重比较)。没有观察到重大不良事件。结论:玻璃体内注射贝伐单抗可在短期内减少持续性活动性NV引起的荧光素渗漏,而不会导致糖尿病性视网膜病变患者视力下降。值得进一步研究,以研究贝伐单抗抗VEGF治疗在激光治疗难治的糖尿病性视网膜病变中的作用。

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