Hirano Takao, Toriyama Yuichi, Iesato Yasuhiro, Ishibazawa Akihiro, Sugimoto Masahiko, Takamura Yoshihiro, Nagaoka Taiji, Murata Toshinori
Department of Ophthalmology, Shinshu University School of Medicine, Matsumoto, Japan.
Department of Ophthalmology, Asahikawa Medical University, Asahikawa, Japan.
Ophthalmic Res. 2019;61(1):10-18. doi: 10.1159/000492005. Epub 2018 Oct 10.
Evaluate the effect of foveal leaking microaneurysms (MAs) on the required number of intravitreal ranibiz-umab (IVR) injections in the treatment of center-involving diabetic macular edema (DME) when treated with focal/grid laser.
A pilot study of prospective, nonrandomized, multicenter clinical trial.
This study enrolled 21 eyes with DME for which pro re nata IVR injections were combined with short-pulse focal/grid laser. At 12 months, best-corrected visual acuity (BCVA), central subfield macular thickness (CMT), and the required number of IVRs to maintain CMT < 300 µm were compared between eyes with or without foveal leaking MAs, termed the MA(+) and MA(-) groups, respectively.
Significant CMT improvements (p < 0.0001) and increased BCVA of 4.0 ± 8.5 letters were observed at 12 months. The MA(-) group required significantly fewer IVRs than did the MA(+) group (mean: 4.9 ± 3.0 vs. 8.6 ± 3.0; p = 0.0306). In the latter 6 months of the 1-year follow-up, 50% (4/8) of MA(-) eyes did not require any IVR administration to sustain CMT < 300 µm.
A combination therapy of short-pulse focal/grid laser and reduced IVR injections appeared noninferior to previous reports of IVR monotherapy. Further large-scale investigations are warranted.
评估在采用局灶/格栅激光治疗累及黄斑中心的糖尿病性黄斑水肿（DME）时，黄斑区渗漏微动脉瘤（MAs）对玻璃体内注射雷珠单抗（IVR）所需次数的影响。
一项前瞻性、非随机、多中心临床试验的初步研究。
本研究纳入了21例DME患者的眼睛，对其进行按需IVR注射并联合短脉冲局灶/格栅激光治疗。在12个月时，比较有或没有黄斑区渗漏MAs的眼睛（分别称为MA(+)组和MA(-)组）之间的最佳矫正视力（BCVA）、黄斑中心子区域厚度（CMT）以及维持CMT<300μm所需的IVR注射次数。
在12个月时观察到CMT有显著改善（p<0.0001），BCVA提高了4.0±8.5个字母。MA(-)组所需的IVR注射次数明显少于MA(+)组（平均：4.9±3.0次对8.6±3.0次；p=0.0306）。在1年随访的后6个月中，50%（4/8）的MA(-)组眼睛无需任何IVR注射即可维持CMT<300μm。
短脉冲局灶/格栅激光联合减少IVR注射的联合治疗似乎不劣于先前关于IVR单药治疗的报道。有必要进行进一步的大规模研究。
