Joslin Diabetes Center, Beetham Eye Institute, Department of Ophthalmology, Harvard University Medical School, Boston, Massachusetts, USA.
Retina. 2011 Nov;31(10):2084-94. doi: 10.1097/IAE.0b013e3182111669.
To evaluate efficacy, safety, and causes of vision loss among 813 patients (1,392 eyes) with moderately severe to very severe nonproliferative diabetic retinopathy from the Protein Kinase C β Inhibitor-Diabetic Retinopathy Study and Protein Kinase C β Inhibitor-Diabetic Retinopathy Study 2 ruboxistaurin (RBX) protein kinase C β inhibitor trials.
Patients in these 3-year, randomized, placebo-controlled, double-masked, Phase 3 trials had best-corrected Early Treatment Diabetic Retinopathy Study visual acuity ≥45 letters (∼20/125 Snellen), Early Treatment Diabetic Retinopathy Study retinopathy level 47A/B-53E, and no previous panretinal photocoagulation in ≥1 eye. Patients received placebo (N = 401) or RBX 32 mg/day (N = 412). Data from the 2 studies were combined and masked evaluation of retinal photographs was performed for cause of visual decline in all patients experiencing sustained moderate visual loss (≥15-letter loss sustained for the last 6 months of study).
In the studies combined, sustained moderate visual loss occurred in 10.2% of placebo-treated patients versus 6.1% of RBX-treated patients (P = 0.011). A ≥15-letter gain occurred in 2.4% of placebo versus 4.7% of RBX eyes (P = 0.021) and a ≥15-letter loss occurred in 11.4% versus 7.4%, respectively (P = 0.012). Diabetic macular edema was the probable primary cause of vision loss. Among eyes without focal/grid photocoagulation at baseline, fewer RBX group eyes (26.7%) required initial focal/grid photocoagulation versus placebo (35.6%; P = 0.008). No safety concerns were identified.
Analysis of data combined from two similar studies adds further statistical significance to RBX's beneficial effects on visual loss, need for focal laser, and vision gain, most likely through effects on macular edema.
评估 813 例（1392 只眼）中度至重度非增殖性糖尿病视网膜病变患者接受蛋白激酶 Cβ抑制剂-糖尿病视网膜病变研究和蛋白激酶 Cβ抑制剂-糖尿病视网膜病变研究 2 中罗匹卡司他丁（RBX）蛋白激酶 Cβ抑制剂治疗的疗效、安全性和视力丧失的原因。
这些为期 3 年的随机、安慰剂对照、双盲、3 期试验的患者最佳矫正后早期治疗糖尿病视网膜病变研究视力≥45 个字母（约 20/125 Snellen）、早期治疗糖尿病视网膜病变研究视网膜病变水平 47A/B-53E，并且至少 1 只眼无全视网膜光凝。患者接受安慰剂（N=401）或 RBX 32mg/天（N=412）。将两项研究的数据合并，并对所有持续中度视力丧失（研究最后 6 个月持续≥15 个字母丧失）的患者进行视网膜照片的盲法评估，以确定视力下降的原因。
在合并的研究中，安慰剂治疗的患者中有 10.2%发生持续中度视力丧失，而 RBX 治疗的患者中为 6.1%（P=0.011）。安慰剂组有 2.4%的眼出现≥15 个字母的提高，而 RBX 组有 4.7%（P=0.021），有 11.4%的眼出现≥15 个字母的丧失，而 RBX 组为 7.4%（P=0.012）。糖尿病性黄斑水肿是视力丧失的主要可能原因。在基线时没有局灶性/格栅光凝的眼中，RBX 组需要初始局灶性/格栅光凝的眼数（26.7%）少于安慰剂组（35.6%；P=0.008）。未发现安全性问题。
对两项类似研究的数据进行合并分析，进一步证明 RBX 对视力丧失、对需要进行局灶性激光治疗和视力提高的有益作用，这可能是通过对黄斑水肿的作用。
