Effect of ruboxistaurin in patients with diabetic macular edema: Thirty-month results of the randomized PKC-DMES clinical trial

Archives of Ophthalmology

Volumn 125, Issue 3, 2007, Pages 318-324

  Aiello, Lloyd Paul ^a,b   Davis, Matthew D ^a   Girach, Aniz ^a   Hu, Kuolung ^a   Milton, Roy C ^a   Sheetz, Matthew J ^a   Vignati, Louis ^a  

^a Joslin Diabetes Center ^*

^b JOSLIN DIABETES CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

MESYLIC ACID; PLACEBO; RUBOXISTAURIN;

ADULT; AGED; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIABETIC MACULAR EDEMA; DISEASE COURSE; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; EYE PHOTOGRAPHY; FEMALE; HUMAN; LASER COAGULATION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OPHTHALMOSCOPY; OUTCOME ASSESSMENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; VISUAL ACUITY;

ADMINISTRATION, ORAL; ADULT; AGED; AGED, 80 AND OVER; DIABETES MELLITUS, TYPE 1; DIABETES MELLITUS, TYPE 2; DIABETIC RETINOPATHY; DISEASE PROGRESSION; DOUBLE-BLIND METHOD; ENZYME INHIBITORS; FEMALE; HUMANS; INDOLES; LASER COAGULATION; MACULAR EDEMA, CYSTOID; MALE; MALEIMIDES; MIDDLE AGED; PROSPECTIVE STUDIES; PROTEIN KINASE C; TREATMENT OUTCOME; VISUAL ACUITY;

EID: 33947236725     PISSN: 00039950     EISSN: 00039950     Source Type: Journal    
DOI: 10.1001/archopht.125.3.318     Document Type: Article

References (26)

1. Javitt JC, Aiello LP, Chiang Y, Ferris FL III, Canner JK, Greenfield S. Preventive eye care in people with diabetes is cost-saving to the federal government: implications for health-care reform. Diabetes Care. 1994;17:909-917.
2. Henricsson M, Sellman A, Tyrberg M, Groop L. Progression to proliferative retinopathy and macular oedema requiring treatment: assessment of the alternative classification of the Wisconsin Study. Acta Ophthalmol Scand. 1999;77:218-223.
3. Klein R, Klein BE, Moss SE. Visual impairment in diabetes. Ophthalmology. 1984;91:1-9.
4. Klein R, Klein BE, Moss SE, Davis MD, DeMets DL. The Wisconsin epidemiologic study of diabetic retinopathy, IV: diabetic macular edema. Ophthalmology. 1984;91:1464-1474.
5. Early Treatment Diabetic Retinopathy Study Research Group. Early Treatment Diabetic Retinopathy Study design and baseline patient characteristics: ETDRS report number 7. Ophthalmology. 1991;98:741-756.
6. Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993;329:977-986.
7. UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33): UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998;352:837-853.
8. Sheetz MJ, King GL. Molecular understanding of hyperglycemia's adverse effects for diabetic complications. JAMA. 2002;288:2579-2588.
9. Mellor H, Parker PJ. The extended protein kinase C superfamily. Biochem J. 1998;332:281-292.
10. Bullock WH, Magnuson SR, Choi S, Gunn DE, Rudolph J. Prospects for kinase activity modulators in the treatment of diabetes and diabetic complications. Curr Top Med Chem. 2002;2:915-938.
11. Aiello LP, Bursell S-E, Clermont A, et al. Vascular endothelial growth factor-induced retinal permeability is mediated by protein kinase C in vivo and suppressed by an orally effective β-isoform-selective inhibitor. Diabetes. 1997;46:1473-1480.
12. Xu X, Zhu Q, Xia X, Zhang S, Gu Q, Luo D. Blood-retinal barrier breakdown induced by activation of protein kinase C via vascular endothelial growth factor in streptozotocin-induced diabetic rats. Curr Eye Res. 2004;28:251-256.
13. Danis RP, Bingaman DP, Jirousek M, Yang Y. Inhibition of intraocular neovascularization caused by retinal ischemia in pigs by PKC beta inhibition with LY333531. Invest Ophthalmol Vis Sci. 1998;39:171-179.
14. Suzuma K, Takahara N, Suzuma I, et al. Characterization of protein kinase C β isoform's action on retinoblastoma protein phosphorylation, vascular endothelial growth factor-induced endothelial cell proliferation, and retinal neovascularization. Proc Natl Acad Sci U S A. 2002;99:721-726.
15. Aiello LP, Bursell SE, Devries T, Alatorre C, King GL, Ways DK. Inhibition of PKC beta by oral administration of ruboxistaurin is well tolerated and ameliorates diabetes-induced retinal hemodynamic abnormalities in patients. Invest Ophthalmol Vis Sci. 2006;47:86-92.
16. Koya D, Haneda M, Nakagawa H, et al. Amelioration of accelerated diabetic mesangial expansion by treatment with a PKC beta; inhibitor in diabetic db/db mice, a rodent model for type 2 diabetes. FASEB J. 2000;14:439-447.
17. Ishii H, Jirousek MR, Koya D, et al. Amelioration of vascular dysfunctions in diabetic rats by an oral PKC beta inhibitor. Science. 1996;272:728-731.
18. Cotter MA, Jack AM, Cameron NE. Effects of the protein kinase C beta inhibitor LY333531 on neural and vascular function in rats with streptozotocin-induced diabetes. Clin Sci (Lond). 2002;103:311-321.
19. Kelly DJ, Zhang Y, Hepper C, et al. Protein kinase C beta inhibition attenuates the progression of experimental diabetic nephropathy in the presence of continued hypertension. Diabetes. 2003;52:512-518.
20. The PKC-DRS Study Group. The effect of ruboxistaurin on visual loss in patients with moderately severe to very severe nonproliferative diabetic retinopathy: initial results of the PKC-DRS multicenter randomized clinical trial. Diabetes. 2005;54:2188-2197.
21. World Medical Association declaration of Helsinki: recommendations guiding physicians in biomedical research involving human subjects. JAMA. 1997;277:925-926.
22. Early Treatment Diabetic Retinopathy Study Research Group. Early Treatment Diabetic Retinopathy Study Manual of Operations. Springfield, Va: US Dept of Commerce, National Technical Information Service; 1993.
23. The Age-Related Eye Disease Study Research Group. The age-related eye disease study (AREDS) system for classifying cataracts from photographs: AREDS report No. 4. Am J Ophthalmol. 2001;131:167-175.
24. Early Treatment Diabetic Retinopathy Study Research Group. Grading diabetic retinopathy from stereoscopic color fundus photographs-an extension of the modified Airlie House classification: ETDRS report number 10. Ophthalmology. 1991;98:786-806.
25. Early Treatment Diabetic Retinopathy Study Research Group. Fundus photographic risk factors for progression of diabetic retinopathy: ETDRS report number 12. Ophthalmology. 1991;98:823-833.
26. Campochiaro PA. Reduction of diabetic macular edema by oral administration of the kinase inhibitor PKC412. Invest Ophthalmol Vis Sci. 2004;45:922-931.