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Effect of ruboxistaurin in patients with diabetic macular edema: thirty-month results of the randomized PKC-DMES clinical trial.
Arch Ophthalmol. 2007 Mar; 125(3):318-24.AO

Abstract

OBJECTIVE

To evaluate the safety and efficacy of orally administered ruboxistaurin (RBX) as a mesylate salt in patients with diabetic macular edema (DME).

DESIGN

Multicenter, double-masked, randomized, placebo-controlled study of 686 patients receiving placebo or RBX orally (4, 16, or 32 mg/d) for 30 months. At baseline, patients had DME farther than 300 mum from the center of the macula, an Early Treatment Diabetic Retinopathy Study retinopathy severity level from 20 to 47A without prior photocoagulation, and an Early Treatment Diabetic Retinopathy Study visual acuity of 75 or more letters in the study eye. The primary study outcome was progression to sight-threatening DME or application of focal/grid photocoagulation for DME. Main Outcome Measure Masked grading of stereoscopic fundus photographs.

RESULTS

The delay in progression to the primary outcome was not statistically significant (32 mg of RBX vs placebo, P = .14 [unadjusted]; Cox proportional hazards model adjusted for covariates, hazards ratio = 0.73; 95% confidence interval, 0.53-1.0; P = .06). However, application of focal/grid photocoagulation prior to progression to sight-threatening DME varied by site, and a secondary analysis of progression to sight-threatening DME alone showed that 32 mg of RBX per day reduced progression, compared with placebo (P = .054 [unadjusted]; Cox proportional hazards model, hazards ratio = 0.66; 95% confidence interval, 0.47-0.93; P = .02).

CONCLUSIONS

Although progression to the primary outcome was not delayed, daily oral administration of RBX may delay progression of DME to a sight-threatening stage. Ruboxistaurin was well tolerated in this study.

Authors

No affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17353401

Citation

PKC-DMES Study Group. "Effect of Ruboxistaurin in Patients With Diabetic Macular Edema: Thirty-month Results of the Randomized PKC-DMES Clinical Trial." Archives of Ophthalmology (Chicago, Ill. : 1960), vol. 125, no. 3, 2007, pp. 318-24.
PKC-DMES Study Group. Effect of ruboxistaurin in patients with diabetic macular edema: thirty-month results of the randomized PKC-DMES clinical trial. Arch Ophthalmol. 2007;125(3):318-24.
PKC-DMES Study Group. (2007). Effect of ruboxistaurin in patients with diabetic macular edema: thirty-month results of the randomized PKC-DMES clinical trial. Archives of Ophthalmology (Chicago, Ill. : 1960), 125(3), 318-24.
PKC-DMES Study Group. Effect of Ruboxistaurin in Patients With Diabetic Macular Edema: Thirty-month Results of the Randomized PKC-DMES Clinical Trial. Arch Ophthalmol. 2007;125(3):318-24. PubMed PMID: 17353401.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of ruboxistaurin in patients with diabetic macular edema: thirty-month results of the randomized PKC-DMES clinical trial. A1 - ,, PY - 2007/3/14/pubmed PY - 2007/3/23/medline PY - 2007/3/14/entrez SP - 318 EP - 24 JF - Archives of ophthalmology (Chicago, Ill. : 1960) JO - Arch. Ophthalmol. VL - 125 IS - 3 N2 - OBJECTIVE: To evaluate the safety and efficacy of orally administered ruboxistaurin (RBX) as a mesylate salt in patients with diabetic macular edema (DME). DESIGN: Multicenter, double-masked, randomized, placebo-controlled study of 686 patients receiving placebo or RBX orally (4, 16, or 32 mg/d) for 30 months. At baseline, patients had DME farther than 300 mum from the center of the macula, an Early Treatment Diabetic Retinopathy Study retinopathy severity level from 20 to 47A without prior photocoagulation, and an Early Treatment Diabetic Retinopathy Study visual acuity of 75 or more letters in the study eye. The primary study outcome was progression to sight-threatening DME or application of focal/grid photocoagulation for DME. Main Outcome Measure Masked grading of stereoscopic fundus photographs. RESULTS: The delay in progression to the primary outcome was not statistically significant (32 mg of RBX vs placebo, P = .14 [unadjusted]; Cox proportional hazards model adjusted for covariates, hazards ratio = 0.73; 95% confidence interval, 0.53-1.0; P = .06). However, application of focal/grid photocoagulation prior to progression to sight-threatening DME varied by site, and a secondary analysis of progression to sight-threatening DME alone showed that 32 mg of RBX per day reduced progression, compared with placebo (P = .054 [unadjusted]; Cox proportional hazards model, hazards ratio = 0.66; 95% confidence interval, 0.47-0.93; P = .02). CONCLUSIONS: Although progression to the primary outcome was not delayed, daily oral administration of RBX may delay progression of DME to a sight-threatening stage. Ruboxistaurin was well tolerated in this study. SN - 0003-9950 UR - https://www.unboundmedicine.com/medline/citation/17353401/Effect_of_ruboxistaurin_in_patients_with_diabetic_macular_edema:_thirty_month_results_of_the_randomized_PKC_DMES_clinical_trial_ L2 - https://jamanetwork.com/journals/jamaophthalmology/fullarticle/10.1001/archopht.125.3.318 DB - PRIME DP - Unbound Medicine ER -