Effect of ruboxistaurin on visual loss in patients with diabetic retinopathy

To evaluate the effect of ruboxistaurin, an orally administered protein kinase C beta (PKC beta) isozyme-selective inhibitor, on vision loss in patients with diabetes. Thirty-six-month, randomized, double-masked, placebo-controlled, parallel, multicenter trial. Six hundred eighty-five patients rando...

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Vydané v:	Ophthalmology (Rochester, Minn.) Ročník 113; číslo 12; s. 2221
Hlavní autori:	Aiello, Lloyd Paul, Davis, Matthew D, Girach, Aniz, Kles, Keri A, Milton, Roy C, Sheetz, Matthew J, Vignati, Louis, Zhi, Xin Eric
Médium:	Journal Article
Jazyk:	English
Vydavateľské údaje:	United States 01.12.2006
Predmet:	Administration, Oral Adult Aged Aged, 80 and over Diabetic Retinopathy - drug therapy Disease Progression Double-Blind Method Enzyme Inhibitors - adverse effects Enzyme Inhibitors - therapeutic use Female Humans Indoles - adverse effects Indoles - therapeutic use Macular Edema - drug therapy Macular Edema - physiopathology Male Maleimides - adverse effects Maleimides - therapeutic use Middle Aged Protein Kinase C - antagonists & inhibitors Protein Kinase C beta Vision Disorders - prevention & control Visual Acuity - drug effects
ISSN:	1549-4713, 1549-4713
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Abstract	To evaluate the effect of ruboxistaurin, an orally administered protein kinase C beta (PKC beta) isozyme-selective inhibitor, on vision loss in patients with diabetes. Thirty-six-month, randomized, double-masked, placebo-controlled, parallel, multicenter trial. Six hundred eighty-five patients randomized at 70 clinical sites. Ophthalmologic examination was performed at screening and at each 3-month visit. Retinopathy status was assessed every 6 months with Early Treatment Diabetic Retinopathy Study (ETDRS) standard 7-field 30 degrees color stereoscopic fundus photography. Levels of diabetic retinopathy and diabetic macular edema were determined by 2 independent graders masked to site and treatment assignment, with additional independent adjudication as required. Eligible patients had a best-corrected visual acuity (VA) score of > or =45 letters, retinopathy level > or = 47A and < or = 53E, and no prior panretinal photocoagulation in at least one eye. Effect of oral ruboxistaurin (32 mg/day) on reduction of sustained moderate visual loss (> or =15-letter decrease in ETDRS VA score maintained > or = 6 months) in patients with moderately severe to very severe nonproliferative diabetic retinopathy. Sustained moderate visual loss occurred in 9.1% of placebo-treated patients versus 5.5% of ruboxistaurin-treated patients (40% risk reduction, P = 0.034). Mean VA was better in the ruboxistaurin-treated patients after 12 months. Baseline-to-end point visual improvement of > or =15 letters was more frequent (4.9% vs. 2.4%) and > or =15-letter worsening was less frequent (6.7% vs. 9.9%) in ruboxistaurin-treated patients relative to placebo (P = 0.005). When clinically significant macular edema was >100 microm from the center of the macula at baseline, ruboxistaurin treatment was associated with less frequent progression of edema to within 100 microm (68% vs. 50%, P = 0.003). Initial laser treatment for macular edema was 26% less frequent in eyes of ruboxistaurin-treated patients (P = 0.008). Oral ruboxistaurin treatment reduced vision loss, need for laser treatment, and macular edema progression, while increasing occurrence of visual improvement in patients with nonproliferative retinopathy.
AbstractList	To evaluate the effect of ruboxistaurin, an orally administered protein kinase C beta (PKC beta) isozyme-selective inhibitor, on vision loss in patients with diabetes.OBJECTIVETo evaluate the effect of ruboxistaurin, an orally administered protein kinase C beta (PKC beta) isozyme-selective inhibitor, on vision loss in patients with diabetes.Thirty-six-month, randomized, double-masked, placebo-controlled, parallel, multicenter trial.DESIGNThirty-six-month, randomized, double-masked, placebo-controlled, parallel, multicenter trial.Six hundred eighty-five patients randomized at 70 clinical sites.PARTICIPANTSSix hundred eighty-five patients randomized at 70 clinical sites.Ophthalmologic examination was performed at screening and at each 3-month visit. Retinopathy status was assessed every 6 months with Early Treatment Diabetic Retinopathy Study (ETDRS) standard 7-field 30 degrees color stereoscopic fundus photography. Levels of diabetic retinopathy and diabetic macular edema were determined by 2 independent graders masked to site and treatment assignment, with additional independent adjudication as required. Eligible patients had a best-corrected visual acuity (VA) score of > or =45 letters, retinopathy level > or = 47A and < or = 53E, and no prior panretinal photocoagulation in at least one eye.METHODSOphthalmologic examination was performed at screening and at each 3-month visit. Retinopathy status was assessed every 6 months with Early Treatment Diabetic Retinopathy Study (ETDRS) standard 7-field 30 degrees color stereoscopic fundus photography. Levels of diabetic retinopathy and diabetic macular edema were determined by 2 independent graders masked to site and treatment assignment, with additional independent adjudication as required. Eligible patients had a best-corrected visual acuity (VA) score of > or =45 letters, retinopathy level > or = 47A and < or = 53E, and no prior panretinal photocoagulation in at least one eye.Effect of oral ruboxistaurin (32 mg/day) on reduction of sustained moderate visual loss (> or =15-letter decrease in ETDRS VA score maintained > or = 6 months) in patients with moderately severe to very severe nonproliferative diabetic retinopathy.MAIN OUTCOME MEASUREEffect of oral ruboxistaurin (32 mg/day) on reduction of sustained moderate visual loss (> or =15-letter decrease in ETDRS VA score maintained > or = 6 months) in patients with moderately severe to very severe nonproliferative diabetic retinopathy.Sustained moderate visual loss occurred in 9.1% of placebo-treated patients versus 5.5% of ruboxistaurin-treated patients (40% risk reduction, P = 0.034). Mean VA was better in the ruboxistaurin-treated patients after 12 months. Baseline-to-end point visual improvement of > or =15 letters was more frequent (4.9% vs. 2.4%) and > or =15-letter worsening was less frequent (6.7% vs. 9.9%) in ruboxistaurin-treated patients relative to placebo (P = 0.005). When clinically significant macular edema was >100 microm from the center of the macula at baseline, ruboxistaurin treatment was associated with less frequent progression of edema to within 100 microm (68% vs. 50%, P = 0.003). Initial laser treatment for macular edema was 26% less frequent in eyes of ruboxistaurin-treated patients (P = 0.008).RESULTSSustained moderate visual loss occurred in 9.1% of placebo-treated patients versus 5.5% of ruboxistaurin-treated patients (40% risk reduction, P = 0.034). Mean VA was better in the ruboxistaurin-treated patients after 12 months. Baseline-to-end point visual improvement of > or =15 letters was more frequent (4.9% vs. 2.4%) and > or =15-letter worsening was less frequent (6.7% vs. 9.9%) in ruboxistaurin-treated patients relative to placebo (P = 0.005). When clinically significant macular edema was >100 microm from the center of the macula at baseline, ruboxistaurin treatment was associated with less frequent progression of edema to within 100 microm (68% vs. 50%, P = 0.003). Initial laser treatment for macular edema was 26% less frequent in eyes of ruboxistaurin-treated patients (P = 0.008).Oral ruboxistaurin treatment reduced vision loss, need for laser treatment, and macular edema progression, while increasing occurrence of visual improvement in patients with nonproliferative retinopathy.CONCLUSIONOral ruboxistaurin treatment reduced vision loss, need for laser treatment, and macular edema progression, while increasing occurrence of visual improvement in patients with nonproliferative retinopathy. To evaluate the effect of ruboxistaurin, an orally administered protein kinase C beta (PKC beta) isozyme-selective inhibitor, on vision loss in patients with diabetes. Thirty-six-month, randomized, double-masked, placebo-controlled, parallel, multicenter trial. Six hundred eighty-five patients randomized at 70 clinical sites. Ophthalmologic examination was performed at screening and at each 3-month visit. Retinopathy status was assessed every 6 months with Early Treatment Diabetic Retinopathy Study (ETDRS) standard 7-field 30 degrees color stereoscopic fundus photography. Levels of diabetic retinopathy and diabetic macular edema were determined by 2 independent graders masked to site and treatment assignment, with additional independent adjudication as required. Eligible patients had a best-corrected visual acuity (VA) score of > or =45 letters, retinopathy level > or = 47A and < or = 53E, and no prior panretinal photocoagulation in at least one eye. Effect of oral ruboxistaurin (32 mg/day) on reduction of sustained moderate visual loss (> or =15-letter decrease in ETDRS VA score maintained > or = 6 months) in patients with moderately severe to very severe nonproliferative diabetic retinopathy. Sustained moderate visual loss occurred in 9.1% of placebo-treated patients versus 5.5% of ruboxistaurin-treated patients (40% risk reduction, P = 0.034). Mean VA was better in the ruboxistaurin-treated patients after 12 months. Baseline-to-end point visual improvement of > or =15 letters was more frequent (4.9% vs. 2.4%) and > or =15-letter worsening was less frequent (6.7% vs. 9.9%) in ruboxistaurin-treated patients relative to placebo (P = 0.005). When clinically significant macular edema was >100 microm from the center of the macula at baseline, ruboxistaurin treatment was associated with less frequent progression of edema to within 100 microm (68% vs. 50%, P = 0.003). Initial laser treatment for macular edema was 26% less frequent in eyes of ruboxistaurin-treated patients (P = 0.008). Oral ruboxistaurin treatment reduced vision loss, need for laser treatment, and macular edema progression, while increasing occurrence of visual improvement in patients with nonproliferative retinopathy.
Author	Girach, Aniz Sheetz, Matthew J Milton, Roy C Vignati, Louis Aiello, Lloyd Paul Davis, Matthew D Kles, Keri A Zhi, Xin Eric
AuthorAffiliation	Beetham Eye Institute, Joslin Diabetes Center, 1 Joslin Place, Boston, MA 02215, USA. LPAiello@Joslin.Harvard.edu
AuthorAffiliation_xml	– name: Beetham Eye Institute, Joslin Diabetes Center, 1 Joslin Place, Boston, MA 02215, USA. LPAiello@Joslin.Harvard.edu
Author_xml	– sequence: 1 givenname: Lloyd Paul surname: Aiello fullname: Aiello, Lloyd Paul – sequence: 2 givenname: Matthew D surname: Davis fullname: Davis, Matthew D – sequence: 3 givenname: Aniz surname: Girach fullname: Girach, Aniz – sequence: 4 givenname: Keri A surname: Kles fullname: Kles, Keri A – sequence: 5 givenname: Roy C surname: Milton fullname: Milton, Roy C – sequence: 6 givenname: Matthew J surname: Sheetz fullname: Sheetz, Matthew J – sequence: 7 givenname: Louis surname: Vignati fullname: Vignati, Louis – sequence: 8 givenname: Xin Eric surname: Zhi fullname: Zhi, Xin Eric
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/16989901$$D View this record in MEDLINE/PubMed
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SubjectTerms	Administration, Oral Adult Aged Aged, 80 and over Diabetic Retinopathy - drug therapy Disease Progression Double-Blind Method Enzyme Inhibitors - adverse effects Enzyme Inhibitors - therapeutic use Female Humans Indoles - adverse effects Indoles - therapeutic use Macular Edema - drug therapy Macular Edema - physiopathology Male Maleimides - adverse effects Maleimides - therapeutic use Middle Aged Protein Kinase C - antagonists & inhibitors Protein Kinase C beta Vision Disorders - prevention & control Visual Acuity - drug effects
Title	Effect of ruboxistaurin on visual loss in patients with diabetic retinopathy
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