Results of Visual Acuity and Foveal Thickness in Diabetic Macular Edema after Vitrectomy

Purpose

To report results of an investigation of visual acuity (VA) and foveal thickness in diabetic macular edema (DME) patients after vitrectomy.

Methods

A retrospective study was performed of the records of 47 patients (61 eyes) who received pars plana vitrectomy (PPV) for DME. All eyes were followed up for over 6 months (mean, 24.8 months; range, 6–60 months). VA and foveal thickness evaluated by optical coherence tomography were reviewed preoperatively and postoperatively.

Results

Twenty-four-month follow-up data were available for 46 of the 61 eyes (75%). VA at the final examination had improved by 0.2 log units or more in 34 of the 61 eyes (56%), remained unchanged in 21 eyes (34%), and worsened in six eyes (10%). Mean foveal thickness decreased by more than 20% of the preoperative value in 50 of the 61 eyes (82%), remained unchanged in ten eyes (16%), and increased by more than 20% in one eye (2%) at the final examination. Postoperative best-corrected visual acuity (BCVA) at both 12 and 24 months was significantly better than preoperative BCVA (P < 0.0001). Foveal thickness at 3 months or later significantly decreased from the preoperative value (P < 0.0001), but remained unchanged in comparison with postoperative 12 months and 24 months values (P = 0.19). Preoperative VA and presence of cystoid macular edema (CME) were independently associated with final visual acuity (P = 0.001).

Conclusions

PPV for DME effectively improved VA and reduced foveal thickness for a longer postoperative period. Better preoperative VA was associated with better final postoperative VA. The eyes without CME tended to have better final postoperative VA.?Jpn J Ophthalmol 2007;51:204–209 © Japanese Ophthalmological Society 2007

     

Clinical Relevance of Parafoveal Intercapillary Spaces and Foveal Avascular Zone in Diabetic Retinopathy Without Macular Edema

PurposeTo investigate the clinical significance of intercapillary spaces on swept source optical coherence tomography angiography images in diabetic retinopathy.MethodsWe retrospectively reviewed 110 eyes of 110 patients suffering from diabetic retinopathy without macular edema for whom 3 × 3 mm swept source optical coherence tomography angiography images centered on the fovea were obtained. Automatic image processing of the superficial slab images allowed us to define the areas encircled by retinal vessels as intercapillary spaces within the central 2-mm circle. We evaluated how the quantitative parameters of intercapillary spaces are associated with logMAR and feasible to diagnose diabetic macular ischemia.ResultsTotal counts (ρ = −0.419; P < 0.001) rather than morphologic parameters of the intercapillary spaces showed a significant correlation with logMAR. There were individual levels of correlations between logMAR and counts of intercapillary spaces in individual sectors. In particular, the summed numbers of the spaces in three highly significant sectors were more significantly associated with logMAR (ρ = −0.515; P < 0.001). Multivariate analyses confirmed that the number of the intercapillary spaces (β = −0.266; P = 0.016) and foveal avascular zone area (β = 0.227; P = 0.042) were related to logMAR. The clustering using the foveal avascular zone area and the number of intercapillary spaces revealed two major clusters; one had fewer intercapillary spaces (P < 0.001) and poorer logMAR (P < 0.001) than the other, with a wide range of the foveal avascular zone area.ConclusionsDecreased intercapillary spaces contribute to visual impairment in diabetic retinopathy and suggest one possible criterion of objective diagnosis of diabetic macular ischemia.     

Evidence-Based Treatment of Diabetic Macular Edema

ABSTRACT

Diabetes mellitus is a chronic disease that affects 415 million people worldwide. Despite treatment advances, diabetic eye disease remains a leading cause of vision loss worldwide. Diabetic macular edema (DME) is a common cause of vision loss in diabetic patients. The pathophysiology is complex and involves multiple pathways that ultimately lead to central retinal thickening and, if untreated, visual loss. First-line treatment of DME has evolved from focal/grid laser established by the Early Treatment of Diabetic Retinopathy Study (ETDRS) to intravitreous pharmacologic therapy. Landmark prospective clinical trials examining the effect of intravitreous injections of vascular endothelial growth factor (VEGF) inhibitors in the treatment of DME have demonstrated improved visual outcomes over focal grid laser. This review focuses on the scientific evidence treatment of DME, disease pathophysiology, clinical disease course, current treatment standards, and emerging novel therapeutic approaches.     

Trans-Tenon's Retrobulbar Injection of Triamcinolone Acetonide for Diffuse Diabetic Macular Edema

Purpose To determine whether a trans-Tenon's retrobulbar injection of triamcinolone acetonide (TA) is a safe and effective treatment for diffuse diabetic macular edema. Methods Thirty-nine eyes of 30 diabetic patients with persistent macular edema were treated with 20 mg of TA injection. Central macular thickness (CMT) determined by optical coherence tomography (OCT) and visual acuity were evaluated before the injection and at 1, 2, 3, and 6 months, and up to 1 year in some eyes, after the injection. Results The CMT decreased significantly from 478 ± 129 μm (mean ± SD) before injection to 316 ± 102 μm at 1 month, 307 ± 104 μm at 2 months, and 275 ± 89 μm at 3 months after a single injection of TA. A 20% reduction of CMT from the initial value was maintained by a single injection of TA in 27 of 39 eyes (69.2%) at 3 months, in 14 of 22 eyes (63.6%) at 6 months, and in 5 of 7 eyes at 12 months. A recurrence of macular edema was observed in 10% of the eyes at 3 months, and in 22.7% at 6 months. The 17 eyes in which vitrectomy had been carried out had a more significant improvement in CMT than the eyes without vitrectomy. Conclusion A 20-mg trans-Tenon's retrobulbar TA injection is a safe and effective treatment for diabetic macular edema. Jpn J Ophthalmol 2005;49:509–515 ? Japanese Ophthalmological Society 2005     

Pars Plana Vitrectomy with Removal of Posterior Hyaloid Face in Treatment of Refractory Diabetic Macular Edema Resistant to Triamcinolone Acetonide

Background Triamcinolone acetonide (TA) has recently been used to treat diabetic macular edema (DME) but its effectiveness is limited. Cases Three patients (three eyes) with unresolved diffuse DME who did not respond to a posterior sub-Tenon's injection of TA underwent vitrectomy. Observations Intraoperatively, it was found that all of the eyes had a posterior hyaloid face that was adherent to a large area of the posterior pole retina, although this had not been detected by slit-lamp biomicroscopy or optical coherence tomography. After vitrectomy and removal of the posterior hyaloid face, there was a significant reduction in the central macular thickness of all three eyes and an improvement in the visual acuity of the patients. Conclusions When TA treatment is not effective for DME, vitrectomy with the complete removal of the posterior hyaloid face, including removal of the internal limiting membrane, should be considered.     

视网膜光凝术后糖尿病性黄斑水肿的临床特征

目的：分析经视网膜光凝治疗后仍合并黄斑水肿的增殖性糖尿病视网膜病变患者黄斑水肿特点及其视功能低下的原因。方法：回顾性系列病例研究。收集2015 年1 月至2016 年12 月在绵阳万江眼科医院治疗的30 例（43 眼）患者临床资料。通过光学相干断层扫描、眼底荧光素血管造影观察影像学特征,归纳其黄斑水肿的特点。根据是否存在某一个临床特征将患眼分为几个亚组,每一临床特征亚组之间最佳矫正视力（BCVA）的差异比较采用独立样本t检验或单因素方差分析。结果：30例（43眼） 患者平均BCVA为3.98 ± 0.58。影像学特征：中、重度黄斑水肿比例大30 眼（70%）,其中直径大于350 μm的大囊腔22 眼（51%）;水肿或囊腔位于中心凹比例大（63%）,对视网膜外层结构（椭圆体带及外界膜）破坏严重（81%）,合并黄斑下微小浆液性视网膜脱离（16%）、黄斑前膜（21%）和糖尿病视神经病（14%）。椭圆体带是否破坏（t=3.62,P=0.001）、水肿是否位于黄斑中心（t=-1.23,P=0.029）、黄斑区是否有大囊腔（t=5.49,P < 0.001）、水肿的程度（F=17.54,P < 0.001）以及是否合并糖尿病视神经病变（t=-5.56,P < 0.001）,各亚组间对应的BCVA比较差异有统计学意义。结论：黄斑水肿广泛存在于视网膜光凝治疗后的糖尿病患者中,以中、重度的黄斑水肿为主,椭圆体带破坏,水肿位于黄斑中心、黄斑区有大囊腔、水肿的程度以及合并糖尿病视神经病变对视力影响较大。     

玻璃体内注射康柏西普对糖尿病性黄斑水肿患者黄斑区视网膜血管密度和中心凹无血管区面积的影响

目的探讨玻璃体内注射抗血管内皮生长因子(vascular endothelial growth factor,VEGF)药物康柏西普治疗糖尿病性黄斑水肿(diabetic macular edema,DME)患者对黄斑区视网膜微循环的影响。方法应用光学相干断层扫描血管成像(optical coherence tomography angiography,OCTA)观察36例DME患者,在接受连续3个月每月1次玻璃体内注射0.5 mg康柏西普治疗前后最佳矫正视力(BCVA)、中心视网膜厚度(central retinal thickness,CRT)及黄斑区浅层和深层视网膜毛细血管的血管密度(vessel density,VD)和中心凹无血管区(foveal avascular zone,FAZ)面积的变化。结果 DME患者康柏西普玻璃体内注射治疗前BCVA为0.26±0.02,3次注射治疗后BCVA分别为0.42±0.04、0.51±0.04及0.54±0.04,治疗后BCVA较治疗前显著提高;治疗前CRT为(472.42±9.68)μm,3次注射治疗后CRT分别为(339.33±6....     

Discrepancy in Fluorescein Angiography and Optical Coherence Tomography Findings of Macular Edema in Intermediate Uveitis

Purpose: To assess discrepancies between fluorescein angiography (FA) and optical coherence tomography (OCT) findings for macular edema (ME) in intermediate uveitis, and investigate treatment response differences corresponding to the discrepant patterns.

Methods: Discrepant results for ME detection between FA and OCT were evaluated. After 6 months, differences in treatment responses were analyzed.

Results: Discrepant findings for ME were found in 21 (44%) of 48 eyes. The best-corrected visual acuity significantly improved after treatment in the concordant group but not in the discrepant groups. Central retinal thickness significantly decreased after treatment in the FA+/OCT+ and FA?/OCT+ groups but not in the FA+/OCT? group. Disease duration was significantly longer in the FA+/OCT? group than in the other groups.

Conclusions: Discrepancies in FA and OCT findings for ME were common in patients with intermediate uveitis. Our results suggest that treatment outcomes may differ according to the discrepant patterns.     

Recurrence of Diabetic Macular Edema After Intravitreous Injection of Triamcinolone Following Vitrectomy

Purpose To evaluate the effects of intravitreous triamcinolone acetonide (TA) after pars plana vitrectomy (PPV) for diabetic macular edema (DME). Methods We studied a prospective interventional case series. TA was injected intravitreously after PPV in 28 eyes (PPV+TA group). Eyes with DME that met the same criteria and had been treated with PPV alone (29 eyes) were used as controls. The best-corrected visual acuity (VA) and foveal thickness determined by optical coherence tomography were followed up for over 12 months in both groups. Chronological changes of VA and foveal thickness between the groups were evaluated. Results In the PPV+TA group, VA had improved at 1 month, but worsened after 3 months. Improvement of foveal thickness was found until 3 months, but not after 6 months. In controls, both VA and foveal thickness continued to improve. The VA of the PPV+TA group was significantly better than that of the controls at 1 and 3 months (P = 0.007 and 0.015, respectively). The foveal thickness of the PPV+TA group was significantly less than that of controls at 1 month (P = 0.0004). These differences became insignificant thereafter, and foveal thickness became significantly worse in the PPV+TA group than in the controls at 12 months (P = 0.0002). Conclusion Although adjunctive use of TA after PPV for DME improved VA and foveal thickness, the effect was transient and foveal thickness increased significantly compared with the PPV alone group at 12 months postoperatively. Jpn J Ophthalmol 2007;51:278–284 @ Japanese Ophthalmological Society 2007     

Long-term Follow-up Results of Pars Plana Vitrectomy for Diabetic Macular Edema

Purpose To analyze the long-term effects of pars plana vitrectomy for diabetic macular edema. Methods Sixty-nine patients (73 eyes) with diabetic macular edema were examined retrospectively after pars plana vitrectomy. The mean follow-up time was 24.6 ± 7.3 months. Results The postoperative best-corrected visual acuity (BCVA) at 12 months was significantly better than the preoperative BCVA, and the improvement was maintained for at least 24 months. The mean central retinal thickness (RT) at 3 months after surgery was significantly thinner than the preoperative central RT, and was maintained for at least 24 months in the cases followed for this period. The postoperative BCVA was significantly worse than the preoperative BCVA at 2 years after surgery in eyes with a preoperative BCVA of ≤0.05. In addition, there was lower probability that the postoperative BCVA would be ≥0.5 in eyes with a preoperative BCVA of <0.3. Conclusions The results indicate that the improvement in the BCVA is attained by 12 months postvitrectomy, and is maintained for at least 24 months. The reduction in RT can be maintained for up to 24 months. The results also indicate that vitrectomy should be performed when the preoperative BCVA is >0.05 at worst. Jpn J Ophthalmol 2007;51:285–291 @ Japanese Ophthalmological Society 2007     

糖尿病性黄斑水肿抗VEGF治疗对视网膜毛细血管影响的研究进展

抗血管内皮生长因子(vascular endothelial growth factor,VEGF)药物对于治疗视网膜疾病,比如渗出性年龄相关性黄斑变性、糖尿病视网膜病变(diabetic retinopathy,DR)、视网膜静脉阻塞具有革命性意义。玻璃体腔内注射抗VEGF药物后能明显减轻黄斑水肿,但同时是否也会破坏视网膜微循环、加快视网膜毛细血管闭塞？本文通过相干光断层扫描血流成像(optical coherence tomography angiography,OCTA)和超广角眼底血管造影(ultra-widefield fluorescein angiography,UWFA)技术观察糖尿病性黄斑水肿(diabetic macular edema,DME)患者抗VEGF治疗对视网膜毛细血管的影响,从黄斑无血管区面积、无灌注区大小及血流密度三方面进行综述。     

Optical Coherence Tomography for Classification and Clinical Evaluation of Macular Edema in Patients with Uveitis

Purpose: To study use of optical coherence tomography (OCT) for macular edema in uveitis. Methods: In total, 44 patients with uveitis and macular edema underwent OCT. Data obtained were correlated with anatomic type, duration of uveitis, and visual acuity (VA). Results: Both cystoid macular edema (CME) and diffuse macular edema (DME) correlate negatively with VA, although statistically CME showed stronger correlation (p = .02). Also CME had higher mean foveal thickness than DME (p < .01). Negative correlation between foveal thickness and VA (p < .05) was observed. CME correlates with uveitis duration (p < .01). Conclusions: CME and macular thickening correlate with VA reduction and uveitis duration.     

雷珠单抗对糖尿病黄斑水肿患者黄斑区视网膜血管密度及形态的影响

目的:应用光学相干断层扫描血管成像(OCTA)观察糖尿病黄斑水肿(DME)患眼经玻璃体腔注射雷珠单抗治疗后短期内黄斑区血管密度及血管形态的变化。方法:收集2019-03/05我院门诊确诊为DME的患者45例52眼,所有患眼均接受玻璃体腔注射雷珠单抗治疗,治疗前和治疗后1wk均行OCTA黄斑区视网膜3mm×3mm范围模式扫描,获得黄斑区浅层毛细血管丛(SCP)血管密度、深层毛细血管丛(DCP)血管密度、微血管瘤个数及中心凹无血管区(FAZ)面积、周长及非圆度指数。结果:SCP血管密度治疗前后无差异(t=1.635,P=0.10);治疗后DCP血管密度(46.59%±4.91%)较治疗前(42.47%±4.16%)增加(t=1.014,P=0.02)。治疗后SCP微血管瘤个数(2.92±0.42个)较治疗前(3.21±0.31个)变化无差异(t=1.623,P=0.21);治疗后DCP微血管瘤个数(6.10±0.67个)较治疗前(8.21±0.41个)减少(t=1.124,P=0.01)。治疗后FAZ面积较治疗前略扩大,FAZ周长略增加,且非圆度指数稍降低,但三者变化均无差异(P>0.05)。结论:玻璃体腔注射雷珠单抗治疗DME患眼后短期内深层毛细血管丛血供增加,且微血管瘤数减少,而浅层毛细血管丛血供及微血管瘤数无明显改变;同时,治疗后短期内FAZ形态(面积、周长及非圆度指数)尚无显著临床意义。     

Disease of the Year: Differential Diagnosis of Uveitic Macular Edema

Uveitic cystoid macular edema (UME) is an important cause of visual morbidity among patients with both infectious and non-infectious uveitis. UME may be associated in more than 30% cases of active uveitis. However, even patients with minimal features of intraocular inflammation may develop recurrent or chronic UME. Therefore, the evaluation and management of UME in patients with uveitis may be challenging. A number of vitreoretinal pathologies may result in UME and accumulation of fluid in the intra- or subretinal space. These need to be carefully distinguished from each other so that appropriate management can be initiated. All types of uveitis, including anterior uveitis (where the primary site of inflammation is not in the posterior segment) can present with UME. Other conditions such as diabetes, and surgery, can present with macular edema. This index review highlights various differential diagnoses of UME and provides illustrative case examples with multimodal imaging evaluation.     

Vitrectomy Combined with Intravitreal Triamcinolone Acetonide Injection and Macular Laser Photocoagulation for Nontractional Diabetic Macular Edema

Purpose

To evaluate the efficacy of vitrectomy combined with intravitreal injection of triamcinolone acetonide (IVTA) and macular laser photocoagulation for the treatment of nontractional diabetic macular edema (DME) refractory to anti-vascular endothelial growth factor (VEGF) therapy.

Methods

Twenty-eight eyes from 28 subjects who were diagnosed with nontractional DME refractory to three or more sequential anti-VEGF injections underwent sequential vitrectomy, IVTA, and macular laser photocoagulation. Changes in best-corrected visual acuity (BCVA) and central subfield thickness (CST) during the six months following vitrectomy were evaluated. Additionally, the CST and BCVA outcomes were compared with those of 26 eyes treated with the same triple therapy for nontractional DME refractory to conventional treatment, such as IVTA or macular laser photocoagulation, or both.

Results

The mean logarithm of the minimum angle of resolution BCVAs before and one, three, and six months after vitrectomy were 0.44 ± 0.15, 0.36 ± 0.18, 0.31 ± 0.14, and 0.34 ± 0.22, respectively. The mean CSTs were 433.3 ± 77.9, 329.9 ± 59.4, 307.2 ± 60.2, and 310.1 ± 80.1 microns, respectively. The values of both BCVA and CST at one, three, and six months were significantly improved from baseline (p < 0.05). The extent of CST reduction during the first month after triple therapy was greater in eyes refractory to conventional treatment than in eyes refractory to anti-VEGF (p = 0.012).

Conclusions

Vitrectomy combined with IVTA and macular laser photocoagulation had a beneficial effect on both anatomical and functional outcomes in eyes with nontractional DME refractory to anti-VEGF therapy.     

Foveal and Macular Thickness in a Japanese Population: The Hisayama Study

Purpose: To examine factors associated with foveal thickness (FT) and macular thickness (MT) in Japanese persons from Hisayama.

Methods: A total of 2216 healthy eyes of 1384 participants were analyzed. Each participant underwent comprehensive physical and ophthalmic examinations, the latter including optical coherence tomography (OCT). Multiple regression analysis was used to determine the relationship of various factors (race, age, sex, refractive error, axial length, diabetes mellitus, fasting plasma glucose levels, alcohol intake and smoking status) to FT (central 1-mm foveal area) and MT (central 3-mm foveal region).

Results: Results of multiple linear regression analysis indicated that age was positively associated with FT (β coefficient 0.214 μm). FT was significantly smaller in women than men (β coefficient ?9.146 μm). For both sexes, body height was positively correlated (β coefficient 0.257 μm), while refractive error and current smoking were negatively associated (β coefficients ?1910 μm and ?4.410 μm, respectively) with FT. With respect to MT, there were negative associations between age, sex (female), and refractive error (β coefficients ?0.268 μm, ?4.815 μm and ?0.699 μm, respectively). For both sexes, body height was positively correlated (β coefficient 0.227 μm), while hypertension and current smoking were negatively associated (β coefficients ?1.999 μm and ?2.758 μm, respectively) with MT.

Conclusions: Our results indicated that age, body height, refractive error, and current smoking were significantly associated with FT, whereas age, body height, refractive error, current smoking, and hypertension were significantly related to MT. Women had significantly smaller FT and MT than men.     

Foveal avascular zone area and parafoveal vessel density measurements in different stages of diabetic retinopathy by optical coherence tomography angiography

AIM: To investigate foveal avascular zone (FAZ) and parafoveal vessel densities (PRVD) by means of optical coherence tomography angiography (OCTA) in diabetic patients with or without diabetic retinopathy (DR) and to assess the reproducibility of FAZ and PRVD measurements. METHODS: Sixty diabetic patients (60 eyes) with different stage of DR (graded according to the International Clinical Severity Scale for DR) and 20 healthy subjects underwent FAZ area and PRVD measurements using OCTA by two experienced examiners. FAZ area in all patients was also assessed using fluorescein angiography (FA). RESULTS: In subject with proliferative DR and with moderate-severe non proliferative DR, FAZ area was significantly increased compared to healthy controls (P=0.025 and P=0.050 respectively measured with OCTA and P=0.025 and P=0.048 respectively measured with FA). OCTA showed significantly less inter-observer variability compared to FA. Concordance correlation coefficient (CCC) for FAZ area measurements was 0.829 (95%CI: 0.736-0.891) P<0.001 with FA and 1.000 (95%CI: 0.999-1.000) P<0.001 with OCTA. CCC was 0.834 (95%CI: 0.746-0.893) P<0.001 and 0.890 (95%CI: 0.828-0.930) P<0.001 for parafoveal superficial and deep vessel density measurements, respectively. CONCLUSION: OCTA shows progressive increase of FAZ area and reduction of PRVD in both superficial and deep plexus at increasing DR severity. FAZ area and PRVD measurements using OCTA are highly reproducible.     

FFA与OCT在糖尿病性黄斑水肿诊断中的作用

目的：研究荧光素眼底血管造影(FFA)和光学相干断层扫描(OCT)在糖尿病性黄斑水肿(DME)诊断中的效果。

方法：选取2015-01/2016-01在我院治疗的糖尿病视网膜病变(DR)患者62例101眼,分别行FFA和OCT检查,对比两种检测技术效果。

结果：FFA检查DME检出率为84.2%,OCT检查DME检出率为77.2%,差异比较无统计学意义(P>0.05); 101眼中OCT和FFA均显示黄斑水肿76眼,未显示黄斑水肿14眼,OCT和FFA诊断符合率为89.1%,Kappa值为0.653,一致性较高( P<0.05); 不同FFA特征患者黄斑中心凹视网膜厚度比较差异有统计学意义(P<0.05),其中弥漫水肿型视网膜厚度为301.43±62.44μm,明显厚于其他患者。

结论：OCT能常规检测高血糖者黄斑区构造改变,但不能替代FFA在黄斑水肿诊断中的影响,两者联合应用利于DME的诊断。     

Effects of Fenofibric Acid on Diabetic Macular Edema: The MacuFen study

Purpose: Fenofibrate reduced progression of diabetic retinopathy in two large randomized studies. The effect of 135?mg fenofibric acid on diabetic macular edema (DME) was evaluated in subjects with existing DME.

Methods: In this double-blind, randomized, placebo-controlled study, 110 subjects with DME not requiring immediate photocoagulation or intraocular treatment with adequate diabetes and blood pressure control received either fenofibric acid or placebo once daily for 1 year. Total macula volume (TMV) and thickness were measured in the worse eye and all eligible eyes with time-domain optical coherence tomography at baseline and quarterly thereafter.

Results: TMV decreased by ?0.35?mm³ (within-group difference) after fenofibric acid treatment and by ?0.11?mm³ after placebo. The between-group comparison of the change was ?0.25?mm³ (95% confidence interval, CI, ?0.645–0.155; p?=?0.227, worse eye analysis). Weighted inner zone thickness and volume decreased by ?18.7?µm and ?0.13?mm³, respectively, for within group difference after fenofibric acid and by ?3.1?µm and ?0.02?mm³, respectively, after placebo. Considering all eligible eyes, thicknesses at central zone, mean inner zone, and entire retina decreased by ?21.3?µm, ?19.8?µm, and ?20.4?µm, respectively, after fenofibric acid. No between-group difference in changes of these measurements was observed. Triglycerides decreased by 23% after fenofibric acid (vs 4% after placebo, p?=?0.001) and high-density lipoprotein cholesterol increased by 8% (vs 0.3%, p?=?0.014). No safety concern was identified.

Conclusion: Subjects treated with fenofibric acid had a modest improvement in TMV, although the study was probably underpowered to detect a benefit over placebo after 1 year.