Intravitreal injection of pegaptanib sodium for proliferative diabetic retinopathy.

Abstract

To compare the efficacy of intravitreal pegaptanib (IVP) with panretinal laser photocoagulation (PRP) in the treatment of active proliferative diabetic retinopathy (PDR). A prospective, randomised, controlled, open-label, exploratory study. Twenty subjects with active PDR were randomly assigned at a 1:1 ratio to receive treatment in one eye either with IVP (0.3 mg) every 6 weeks for 30 weeks or with PRP laser. Efficacy endpoints included regression of retinal neovascularisation (NV), changes from baseline in best-corrected visual acuity (BCVA) and foveal thickness. Safety outcomes included observed and reported adverse events. In 90% of randomised eyes to IVP, retinal NV showed regression by week 3. By week 12, all IVP eyes were completely regressed and maintained through week 36. In the PRP-treated group, at week 36, two eyes demonstrated complete regression, two showed partial regression, and four showed persistent active PDR. The mean change in BCVA at 36 weeks was +5.8 letters in pegaptanib-treated eyes and -6.0 letters in PRP-treated eyes. Only mild to moderate transient ocular adverse events were reported with pegaptanib. IVP produces short-term marked and rapid regression of diabetic retinal NV. Regression of NV was maintained throughout the study and at the final visit.