Intravitreal ranibizumab for diabetic macular edema with prompt versus deferred laser treatment: three-year randomized trial results.
Intravitreal ranibizumab for diabetic macular edema with prompt versus deferred laser treatment: three-year randomized trial results.
复制标题
DOI：
10.1016/j.ophtha.2012.08.022
复制
发表时间：
2012-11
期刊：
影响因子：
13.7
通讯作者：
Melia M
中科院分区：
文献类型：
--
作者：
Diabetic Retinopathy Clinical Research Network;Elman MJ;Qin H;Aiello LP;Beck RW;Bressler NM;Ferris FL 3rd;Glassman AR;Maturi RK;Melia M
报告既往报告的随机试验中的3年随访，该试验评价了玻璃体内注射0.5 mg雷珠单抗治疗糖尿病黄斑水肿（DME）的眼睛中的即时与延迟（≥24周）局灶/网格激光治疗。多中心随机临床试验。361名受试者的视力为20/32至20/320（近似Snellen等效值），DME累及中央凹。雷珠单抗每4周一次，直至不再改善（如果恶化，则重新开始），并立即或延迟（≥24周）随机分配接受局灶/网格激光治疗。第156周（“3年”）访视时的最佳矫正视力和安全性。与即时激光治疗组相比，延迟治疗组从基线到3年访视的视力字母评分的估计平均变化大2.9个字母（9.7 vs 6.8，平均差异= 2.9，95%置信区间0.4 - 5.4，P = 0.02）。在即时激光治疗组和延迟治疗组中，视力增加≥10个字母的患眼百分比分别为42%和56%（P = 0.02），而视力丧失≥10个字母的患眼百分比分别为10%和5%（P = 0.12）。直至3年访视，及时组和延迟组的中位注射次数分别为12次和15次（P = 0.007），从2年至3年访视分别包括1次和2次。在3年访视时，两组中时域光学相干断层扫描显示中央子场厚度≥250 μm的患眼百分比均为36%（P = 0.90）。在延迟组中，54%的患者在试验期间没有接受激光治疗。两组的全身不良事件似乎相似。这些3年的结果表明，在玻璃体内注射雷珠单抗开始时进行局灶/网格激光治疗与延迟激光治疗≥ 24周（涉及黄斑中心凹的DME和视力损害）相比，视力结局并不更好，可能更差。三年时观察到的视力差异可能与即时激光治疗组随访期间累积雷珠单抗注射较少有关。五年的后续行动仍在继续。
To report 3-year follow-up within a previously reported randomized trial evaluating prompt versus deferred (for ≥24 weeks) focal/grid laser treatment in eyes treated with intravitreal 0.5-mg ranibizumab for diabetic macular edema (DME). Multicenter randomized clinical trial. Three hundred and sixty one participants with visual acuity of 20/32 to 20/320 (approximate Snellen equivalent) and DME involving the fovea. Ranibizumab every four weeks until no longer improving (with resumption if worsening) and random assignment to focal/grid laser treatment promptly or deferred (≥24 weeks). Best-corrected visual acuity and safety at the 156-week (“3-year”) visit. The estimated mean change in visual acuity letter score from baseline through the 3-year visit was 2.9 letters greater (9.7 versus 6.8, mean difference = 2.9, 95% confidence interval 0.4 to 5.4, P = 0.02) in the deferral group compared with the prompt laser treatment group. In the prompt laser treatment group and deferral group, respectively, the percentage of eyes with a ≥10 letter gain was 42% and 56% (P = 0.02), while the percentage of eyes with a ≥10 letter loss was 10% and 5% (P = 0.12). Up to the 3-year visit, the median numbers of injections were 12 and 15 in the prompt and deferral groups, respectively (P = 0.007), including 1 and 2, respectively, from the 2- up to the 3-year visit. At the 3-year visit, the percentages of eyes with central subfield thickness ≥250 μm on time domain optical coherence tomography were 36% in both groups (P = 0.90). In the deferral group, 54% did not receive laser treatment during the trial. Systemic adverse events appeared similar in the two groups. These 3-year results suggest that focal/grid laser treatment at the initiation of intravitreal ranibizumab is no better, and possibly worse for vision outcomes, than deferring laser treatment for ≥ 24 weeks in eyes with DME involving the fovea and with vision impairment. Some of the observed difference in visual acuity at three years may be related to fewer cumulative ranibizumab injections during follow-up in the prompt laser treatment group. Follow-up through five years continues.
影响因子：
13.7
作者：
Elman MJ;Bressler NM;Qin H;Beck RW;Ferris FL 3rd;Friedman SM;Glassman AR;Scott IU;Stockdale CR;Sun JK;Diabetic Retinopathy Clinical Research Network
通讯作者：
Diabetic Retinopathy Clinical Research Network
影响因子：
13.7
作者：
Diabetic Retinopathy Clinical Research Network;Elman MJ;Aiello LP;Beck RW;Bressler NM;Bressler SB;Edwards AR;Ferris FL 3rd;Friedman SM;Glassman AR;Miller KM;Scott IU;Stockdale CR;Sun JK
通讯作者：
Sun JK
影响因子：
13.7
作者：
Comparison of Age-related Macular Degeneration Treatments Trials (CATT) Research Group;Martin DF;Maguire MG;Fine SL;Ying GS;Jaffe GJ;Grunwald JE;Toth C;Redford M;Ferris FL 3rd
通讯作者：
Ferris FL 3rd