Comparison of two doses of primary intravitreal bevacizumab (Avastin) for diffuse diabetic macular edema: results from the Pan-American Collaborative Retina Study Group (PACORES) at 12-month follow-up
Comparison of two doses of primary intravitreal bevacizumab (Avastin) for diffuse diabetic macular edema: results from the Pan-American Collaborative Retina Study Group (PACORES) at 12-month follow-up
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DOI：
10.1007/s00417-008-1034-x
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发表时间：
2009-06-01
影响因子：
2.7
通讯作者：
Rodriguez, Francisco J.
中科院分区：
文献类型：
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作者：
Arevalo, J. Fernando;Sanchez, Juan G.;Rodriguez, Francisco J.
报告弥漫性糖尿病黄斑水肿（DDME）患者接受贝伐单抗（AvastinA（R））（1.25 mg或2.5 mg）玻璃体内注射后12个月的解剖学和ETDRS最佳矫正视力（BCVA）反应。此外，比较了两种不同剂量的玻璃体内注射贝伐单抗（IVB）。我们回顾了82例（101只眼）DDME患者的临床记录，在这项干预性回顾性多中心研究。所有至少随访12个月（平均57.6 +/- 8.4周）的患者均纳入本分析。患者在基线和随访时接受了ETDRS最佳矫正视力（BCVA）测试、眼底镜检查、光学相干断层扫描（OCT）和荧光素血管造影（FA），患者的平均年龄为59.7 ± 9.3岁。每只眼睛的IVB注射平均次数为3次（范围：1 - 6次注射），平均间隔为14.1 +/- 10.5周。在1.25 mg组中，1个月时BCVA从20/190，logMAR = 0.97改善至20/85，logMAR 0.62，差异具有统计学显著性（p = 0.0001）。在3个月、6个月和12个月的随访中，这种改善一直保持。12个月时的平均最终BCVA为20/76，logMAR = 0.58（p < 0.001），与基线BCVA存在统计学显著差异。在2.5 mg组中观察到相似的BCVA变化。在1.25 mg组中，平均中心黄斑厚度（CMT）从基线时的419.1 +/- 201.1 A μ m降至1个月时的295.11 A +/- 91.5 A μ m，3个月时的302.1 A +/- 124.2 A μ m，6个月时的313.4.1 A +/- 96.3 A μ m，12个月时为268.2 A +/- 95.5 A μ m（p < 0.0001）。在2.5 mg组中观察到相似的CMT变化。不良事件包括1例患者（1.2%）的一过性高血压、1只眼（1%）的一过性眼内压升高和1只眼（1%）的牵引性视网膜脱离。1.25至2.5 mg剂量的原发性IVB似乎在12个月时为DDME提供了BCVA、OCT和FA的稳定性或改善。玻璃体内注射1.25 mg或2.5 mg贝伐单抗的结果似乎没有差异。此外，我们的研究结果表明，每年至少需要三次注射才能维持BCVA结果。
To report the 12-month anatomic and ETDRS best-corrected visual acuity (BCVA) response after primary intravitreal bevacizumab (AvastinA (R)) (1.25 mg or 2.5 mg) in patients with diffuse diabetic macular edema (DDME). In addition, a comparison of the two different doses of intravitreal bevacizumab (IVB) utilized was made.We reviewed the clinical records of 82 consecutive patients (101 eyes) with DDME in this interventional retrospective multicenter study. All patients with a minimum follow-up of 12 months (mean 57.6 +/- 8.4 weeks) were included in this analysis. Patients underwent ETDRS best-corrected visual acuity (BCVA) testing, ophthalmoscopic examination, optical coherence tomography (OCT), and fluorescein angiography (FA) at baseline and follow-up visits.The mean age of our patients was 59.7 +/- 9.3 years. The mean number of IVB injections per eye was three (range: one to six injections) at a mean interval of 14.1 +/- 10.5 weeks. In the 1.25 mg group at 1 month BCVA improved from 20/190, logMAR = 0.97 to 20/85, logMAR 0.62, a difference that was statistically significant (p = 0.0001). This improvement was maintained throughout the 3-, 6-, and 12-month follow-up. The mean final BCVA at 12 months was 20/76, logMAR = 0.58 (p < 0.001), a statistically significant difference from baseline BCVA. Similar BCVA changes were observed in the 2.5 mg group. In the 1.25 mg group, the mean central macular thickness (CMT) decreased from 419.1 +/- 201.1 A mu m at baseline to 295.11 A +/- 91.5 A mu m at 1 month, 302.1 A +/- 124.2 A mu m at 3 months, 313.4.1 A +/- 96.3 A mu m at 6 months, and 268.2 A +/- 95.5 A mu m at 12 months (p < 0.0001). Similar CMT changes were observed in the 2.5 mg group. Adverse events included transient high blood pressure in one patient (1.2%), transient increased intraocular pressure in one eye (1%), and tractional retinal detachment in one eye (1%).Primary IVB at doses of 1.25 to 2.5 mg seem to provide stability or improvement in BCVA, OCT, and FA in DDME at 12 months. There seems to be no difference in our results between intravitreal bevacizumab at doses of 1.25 mg or 2.5 mg. In addition, our results suggest the need for at least three injections a year to maintain the BCVA results.