Intravitreal injection of pegaptanib sodium for proliferative diabetic retinopathy

Background: To compare the efficacy of intravitreal pegaptanib (IVP) versus panretinal laser photocoagulation (PRP) in the treatment of active proliferative diabetic retinopathy (PDR). Methods: A prospective, randomized, 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), and changes from baseline in best-corrected visual acuity (BCVA), and foveal thickness. Safety outcomes included observed and reported adverse events. Results: In 90% of randomized eyes to IVP, retinal NV showed regression by week 3. By week 12, all IVP-eyes were completely regressed, and was 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. 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. Conclusions: 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.