Safety and efficacy of Macugen [TM] were assessed in a randomized, sham-controlled, double-masked, Phase 2 trial enrolling 172 diabetic subjects with DME affecting the centre of the fovea. The participants were individuals with a best-corrected visual acuity (BCVA) between 20/50 and 20/320 in the study eye and DME involving the centre of the macula for whom the investigator judged laser photocoagulation (at present the standard treatment for clinically significant exudative DME) could be safely withheld for 16 weeks. Intravitreal injections of Macugen [TM], or a sham injection, were administered at baseline and every six weeks thereafter. At Week 36, 0.3 mg Macugen [TM] was significantly superior to sham injection. The results suggested an overall visual acuity (VA) gain as well as a reduced risk of VA loss in eyes with DME treated with intravitreal Macugen [TM]. The 0.3 mg dose seemed to be the most efficacious dose studied, but due to the relatively small number of participants in the study, the authors were unable to identify statistical differences between the different doses given.