Department of Ophthalmology, Ludwig Maximilians University Munich, Mathildenstrasse 8, Munich, Germany. wolfgang.j.mayer @ med.uni-muenchen.de
Ophthalmologica. 2012;228(2):110-6. doi: 10.1159/000338732. Epub 2012 Jun 23.
To compare the efficacy and safety of three intravitreal bevacizumab upload injections followed by a dexamethasone implant versus dexamethasone implant monotherapy in eyes with macular edema due to retinal vein occlusion.
Sixty-four eyes of 64 patients were included in this prospective, consecutive, nonrandomized case series: group 1 consisted of 38 patients (22 with central retinal vein occlusion, CRVO, 16 with branch retinal vein occlusion, BRVO) treated using a dexamethasone implant (Ozurdex) alone; group 2 consisted of 26 patients (14 CRVO, 12 BRVO) treated with three consecutive intravitreal bevacizumab injections at monthly intervals followed by a dexamethasone implant. In case of recurrence, both cohorts received further dexamethasone implants. Preoperatively and monthly best corrected visual acuity (BCVA, ETDRS), central retinal thickness (Spectralis-OCT), intraocular pressure, and wide-angle fundus photodocumentation (Optomap) were performed. The primary clinical endpoint was BCVA at 6 months after initiation of therapy. Secondary endpoints were central retinal thickness and safety of the therapy applied.
In group 1, an increase in BCVA of 2.5 (±1.6) letters in the CRVO and of 13.0 (±3.2) letters in BRVO patients was seen after 6 months, in group 2 of 5.9 (±0.4) letters (CRVO) and 3.8 (±2.4) letters (BRVO), which was not statistically significant. When comparing the two treatment groups with respect to the type of vein occlusion, there was a significant advantage for BRVO patients for the dexamethasone implant monotherapy (BRVO patients in group 1, p = 0.005). Central retinal thickness showed a significant reduction after 6 months only in patients of group 1, both for CRVO (p = 0.01) and BRVO (p = 0.003). First recurrence after the first dexamethasone implant injection occurred after 3.8 months (mean) in CRVO and 3.5 months in BRVO patients (group 1), versus 3.2 and 3.7 months, respectively, in group 2. In group 1, 63.6% with CRVO and 50% with BRVO showed an increased intraocular pressure after treatment; in group 2, 57.1% with CRVO and 50.0% with BRVO, respectively.
In CRVO, there was no difference between the two treatment strategies investigated. However, in BRVO, dexamethasone implant monotherapy was associated with better functional outcome.
比较玻璃体内注射三种贝伐单抗加载注射与单独使用地塞米松植入物治疗视网膜静脉阻塞引起的黄斑水肿的疗效和安全性。
本前瞻性、连续、非随机病例系列研究纳入 64 只眼的 64 例患者:第 1 组 38 例患者(22 例中央视网膜静脉阻塞,CRVO,16 例分支视网膜静脉阻塞,BRVO)接受单独地塞米松植入物(Ozurdex)治疗;第 2 组 26 例患者(14 例 CRVO,12 例 BRVO)接受连续三次玻璃体内贝伐单抗注射,每月一次,随后使用地塞米松植入物。如果复发,两组均接受进一步的地塞米松植入物治疗。术前和每月最佳矫正视力(BCVA,ETDRS)、中心视网膜厚度(Spectralis-OCT)、眼内压和广角眼底照相(Optomap)。主要临床终点是治疗开始后 6 个月的 BCVA。次要终点是中心视网膜厚度和治疗的安全性。
第 1 组 CRVO 患者的 BCVA 增加 2.5(±1.6)个字母,BRVO 患者增加 13.0(±3.2)个字母,6 个月后;第 2 组 CRVO 患者增加 5.9(±0.4)个字母,BRVO 患者增加 3.8(±2.4)个字母,无统计学意义。比较两组静脉阻塞类型的治疗效果,地塞米松植入物单独治疗对 BRVO 患者有显著优势(第 1 组 BRVO 患者,p = 0.005)。仅在第 1 组患者中,6 个月后中心视网膜厚度明显下降,无论是 CRVO(p = 0.01)还是 BRVO(p = 0.003)。第 1 次地塞米松植入物注射后首次复发发生在 CRVO 患者 3.8 个月(平均)和 BRVO 患者 3.5 个月(第 1 组),而第 2 组分别为 3.2 个月和 3.7 个月。第 1 组 63.6%的 CRVO 患者和 50%的 BRVO 患者治疗后眼压升高;第 2 组分别为 57.1%的 CRVO 患者和 50.0%的 BRVO 患者。
在 CRVO 中,两种治疗策略之间没有差异。然而,在 BRVO 中,地塞米松植入物单独治疗与更好的功能结果相关。