Girach A, Aiello L P, Milton R C, Davis M D, Danis R P, Zhi X, Sheetz M J, Vignati L
Department of Ophthalmology, Merck Research Laboratories, Hertfordshire, UK.
Eye (Lond). 2009 Jan;23(1):209-14. doi: 10.1038/eye.2008.324. Epub 2008 Nov 7.
In PKC-DRS2, the efficacy of the oral PKC-beta inhibitor, ruboxistaurin 32 mg/day, was measured by the primary end point of sustained moderate visual loss (SMVL: a > or = 15 letter decrease from baseline on the ETDRS (Early Treatment Diabetic Retinopathy Study) chart sustained at least for the last 6 months of study participation). We now evaluate whether SMVL is more accurate than moderate visual loss (MVL: a single occurrence of a decrease from baseline of > or = 15 ETDRS letters) for predicting future visual loss.
Study eyes with moderately severe to very-severe non-proliferative diabetic retinopathy, best-corrected visual acuity of at least 45 letters on the ETDRS chart (approximately Snellen 20/125), and no prior pan retinal photocoagulation were evaluated in 506 patients (869 eyes) who completed 36 months of treatment.
Sixty-five percentage (26/40) of study eyes with the onset of SMVL within 24 months of enrolment still had SMVL at study completion (36 months). In comparison, only 24% (30/126) with MVL within 24 months had SMVL at study completion. Analyses based on data from 6, 12, and 18 months of treatment were similar.
SMVL is a more predictable measure of subsequent visual loss than is a single time point measure of MVL.
在PKC-DRS2研究中，口服PKC-β抑制剂鲁比前列酮（每日32毫克）的疗效以持续性中度视力下降（SMVL：在糖尿病视网膜病变早期治疗研究（ETDRS）视力表上较基线下降≥15个字母，且在研究参与的最后6个月持续存在）这一主要终点进行衡量。我们现在评估对于预测未来视力下降而言，SMVL是否比中度视力下降（MVL：单次出现较基线下降≥15个ETDRS字母）更准确。
对506例患者（869只眼）进行了评估，这些患者患有中度至重度非增殖性糖尿病视网膜病变，ETDRS视力表上最佳矫正视力至少为45个字母（约相当于Snellen 20/125），且未曾接受过全视网膜光凝治疗，他们完成了36个月的治疗。
在入组后24个月内出现SMVL的研究眼中，65%（26/40）在研究结束时（36个月）仍有SMVL。相比之下，在24个月内出现MVL的患者中，只有24%（30/126）在研究结束时仍有SMVL。基于治疗6个月、12个月和18个月的数据进行的分析结果相似。
与MVL的单次时间点测量相比，SMVL是后续视力下降更具预测性的指标。
