Retina Consultants of Houston, Houston, Texas; Blanton Eye Institute, Houston Methodist Hospital & Weill Cornell Medical College, Houston, Texas.
Retina Consultants of Houston, Houston, Texas.
Ophthalmology. 2018 May;125(5):683-690. doi: 10.1016/j.ophtha.2017.11.026. Epub 2018 Jan 11.
To evaluate the effect of targeted retinal photocoagulation (TRP) on visual and anatomic outcomes and treatment burden in eyes with diabetic macular edema (DME).
Phase I/II prospective, randomized, controlled clinical trial.
Forty eyes of 29 patients with center-involved macular edema secondary to diabetes mellitus.
Eyes with center-involved DME and Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) between 20/32 and 20/320 (Snellen equivalent) were randomized 1:1 to monotherapy with 0.3 mg ranibizumab (Lucentis, Genentech, South San Francisco, CA) or combination therapy with 0.3 mg ranibizumab and TRP guided by widefield fluorescein angiography. All eyes received 4 monthly ranibizumab injections followed by monthly examinations and pro re nata (PRN) re-treatment through 36 months. Targeted retinal photocoagulation was administered outside the macula to areas of retinal capillary nonperfusion plus a 1-disc area margin in the combination therapy arm at week 1, with re-treatment at months 6, 18, and 25, if indicated.
Mean change in ETDRS BCVA from baseline and number of intravitreal injections administered.
At baseline, mean age was 55 years, mean BCVA was 20/63 (Snellen equivalent), and mean central retinal subfield thickness (CRT) was 530 μm. Thirty-four eyes (85%) completed month 36, at which point mean BCVA improved 13.9 and 8.2 letters (P = 0.20) and mean CRT improved 302 and 152 μm (P = 0.03) in the monotherapy and combination therapy arms, respectively. The mean number of injections administered through month 36 was 24.4 (range, 10-34) and 27.1 (range, 12-36), with 73% (362/496) and 80% (433/538) of PRN injections administered (P = 0.004) in the monotherapy and combination therapy arms, respectively. Goldmann visual field isopter III-4e area decreased by 2% and 18% in the monotherapy and combination therapy arms, respectively (P = 0.30).
In this 3-year randomized trial of 40 eyes with DME, there was no evidence that combination therapy with ranibizumab and TRP improved visual outcomes or reduced treatment burden compared with ranibizumab alone.
评估靶向视网膜光凝（TRP）对糖尿病性黄斑水肿（DME）患者视力和解剖学结局及治疗负担的影响。
I/II 期前瞻性、随机、对照临床试验。
29 例患者的 40 只眼，这些患者患有中心性黄斑水肿继发于糖尿病。
患有中心性 DME 和早期糖尿病性视网膜病变研究（ETDRS）最佳矫正视力（BCVA）在 20/32 至 20/320（Snellen 等价物）之间的眼随机分为 1:1 接受单药治疗 0.3mg 雷珠单抗（Lucentis，罗氏，旧金山南部，加利福尼亚州）或联合治疗，联合治疗用 0.3mg 雷珠单抗和宽视野荧光素血管造影引导的 TRP。所有眼接受 4 次每月雷珠单抗注射，然后每月检查并根据需要进行即需治疗（PRN）至 36 个月。在联合治疗臂中，于第 1 周向黄斑外的视网膜毛细血管无灌注区加 1 个视盘直径的区域边缘行靶向视网膜光凝，如果需要，在第 6、18 和 25 个月进行再治疗。
从基线开始的 ETDRS BCVA 平均变化和给予的玻璃体腔内注射次数。
基线时，平均年龄为 55 岁，平均 BCVA 为 20/63（Snellen 等价物），平均中心视网膜下厚度（CRT）为 530μm。34 只眼（85%）完成了第 36 个月，此时单药治疗组和联合治疗组的平均 BCVA 分别改善了 13.9 和 8.2 个字母（P=0.20），平均 CRT 分别改善了 302 和 152μm（P=0.03）。至第 36 个月，给予的平均注射次数分别为 24.4（范围 10-34）和 27.1（范围 12-36），单药治疗组和联合治疗组分别有 73%（362/496）和 80%（433/538）给予了 PRN 注射（P=0.004）。单药治疗组和联合治疗组的 Goldmann 视野等立体 III-4e 区域分别下降了 2%和 18%（P=0.30）。
在这项对 40 只患有 DME 的眼进行的为期 3 年的随机试验中，与单独使用雷珠单抗相比，联合使用雷珠单抗和 TRP 并未显示出改善视力结局或降低治疗负担的证据。
