Purpose

To evaluate the effect of targeted retinal photocoagulation (TRP) on visual and anatomic outcomes and treatment burden in eyes with diabetic macular edema (DME).

Design

Phase I/II prospective, randomized, controlled clinical trial.

Participants

Forty eyes of 29 patients with center-involved macular edema secondary to diabetes mellitus.

Methods

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.

Main Outcome Measures

Mean change in ETDRS BCVA from baseline and number of intravitreal injections administered.

Results

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).

Conclusions

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.

中文翻译：

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靶向性视网膜光凝治疗糖尿病性黄斑水肿伴周围性视网膜非灌注

目的

为了评估针对性的视网膜光凝（TRP）对糖尿病性黄斑水肿（DME）眼睛的视觉和解剖结果以及治疗负担的影响。

设计

I / II期前瞻性，随机对照临床试验。

参加者

29例继发于糖尿病的中心性黄斑水肿的40眼。

方法

中心参与DME和早期治疗性糖尿病视网膜病变研究（ETDRS）的最佳矫正视力（BCVA）在20/32至20/320（Snellen当量）之间的眼睛，按1：1比例随机分配接受0.3 mg雷珠单抗的单药治疗（Lucentis，Genentech） （加利福尼亚州南旧金山）或在宽视野荧光素血管造影术指导下与0.3 mg雷珠单抗和TRP联合治疗。每只眼睛每月接受4次兰尼单抗注射，然后每月进行一次检查，并在36个月内进行前列腺素（PRN）再治疗。有针对性的视网膜光凝治疗是在黄斑区外对视网膜毛细血管非灌注区域进行联合治疗，在第1周时在联合治疗组中进行1-disc区域边缘治疗，如果有适应症，则在第6、18和25个月进行再次治疗。

主要观察指标

与基线和玻璃体内注射次数相比，ETDRS BCVA的平均变化。

结果

在基线时，平均年龄为55岁，平均BCVA为20/63（相当于Snellen），平均中央视网膜亚视野厚度（CRT）为530μm。在第36个月，有34只眼（85％）完成 了手术，此时在单一疗法和联合疗法组中，平均BCVA分别改善了13.9和8.2个字母（P  = 0.20），平均CRT改善了302和152μm（P = 0.03）。到第36个月为止，平均注射次数为24.4（范围10-34）和27.1（范围12-36），其中分别进行了73％（362/496）和80％（433/538）的PRN注射（P  = 0.004）分别在单一疗法和联合疗法组中。单药治疗和联合治疗组的戈德曼视野等高者III-4e面积分别减少了2％和18％（P = 0.30）。

结论

在这项为期40年的DME进行的为期3年的随机试验中，没有证据表明与兰尼单抗相比，兰尼单抗和TRP联合治疗可改善视觉效果或减轻治疗负担。