Journal article
Effect of ruboxistaurin in patients with diabetic macular edema: Thirty-month results of the randomized PKC-DMES clinical trial
Archives of ophthalmology (1960), Vol.125(3), pp.318-324
03/2007
DOI: 10.1001/archopht.125.3.318
PMID: 17353401
Abstract
Objective: To evaluate the safety and efficacy of orally administered ruboxistaurin (RBX) as a mesylate salt in patients with diabetic macular edema (DME). 1 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 mu m 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.
Details
- Title: Subtitle
- Effect of ruboxistaurin in patients with diabetic macular edema: Thirty-month results of the randomized PKC-DMES clinical trial
- Creators
- Lloyd Paul AielloEverett AiLloyd M AielloRajiv AnandMark BlumenkranzDavid BoyerAlexander J BruckerThomas ChandlerLawrence ChongDoug DehningPaul DodsonAlexander EatonDavid FaberDan FinkelsteinJohn V ForresterRobert N FrankCharles GarciaThomas W GardnerKaren M GehrsRoy A GoodartJustin GottliebCraig M GrevenDavid R GuyerDean HainsworthPhilip HooperWillliam E JacksonJames L KinyounMark KipnesMichael L KleinEva M KohnerBaruch KuppermannHilel LewisHelen K LiHenrik Lund-AndersonColin MaDaniel F MartinJuan OrellanaPhilip Y PadenBettine PolakStuart A RossGeorge SharukLawrence J SingermanWilliam E SmiddyMichael TreseJames P TweetenAnew VineJiten VoraBruce WolffenbuttelPKC-DMES Study Group
- Resource Type
- Journal article
- Publication Details
- Archives of ophthalmology (1960), Vol.125(3), pp.318-324
- DOI
- 10.1001/archopht.125.3.318
- PMID
- 17353401
- NLM abbreviation
- Arch Ophthalmol
- ISSN
- 0003-9950
- eISSN
- 1538-3601
- Publisher
- American Medical Association
- Language
- English
- Date published
- 03/2007
- Academic Unit
- Ophthalmology and Visual Sciences
- Record Identifier
- 9984181076602771
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