Ruboxistaurin delays sight-threatening DME

April 5, 2007

Daily oral administration of ruboxistaurin (RBX) may delay progression of diabetic macular oedema (DME) to a sight-threatening stage.

Daily oral administration of ruboxistaurin (RBX) may delay progression of diabetic macular oedema (DME) to a sight-threatening stage, according to a study published in the March issue of Archives of Ophthalmology.

The PKC-DMES multicentre, double-masked, randomized, placebo-controlled study enrolled 686 patients to receive placebo or RBX orally (4, 16 or 32 mg/day) for 30 months. At baseline, subjects had DME farther than 300 µm from the centre of the macular, an Early Treatment Diabetic Retinopathy Study (ETDRS) severity level of between 20 and 47A and an ETDRS visual acuity (VA) of 75 or more.

The researchers found that the delay in progression was not statistically significant (32 mg RBX versus placebo, p=0.14). 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=0.054).

It is thought that, although disease progression was not delayed, daily oral administration of RBX may delay progression to sight-threatening DME.