Based on the above, we believe that administration of infliximab may be a reasonable therapeutic approach in diabetic patients who are in danger of vision loss due to refractory DME. Therefore, a controlled study on the safety and efficacy of infliximab treatment in DME refractory to laser photocoagulation is warranted. Because of our preliminary results (27), we feel that all patients who will participate in such a study should be granted the opportunity to receive infliximab, therefore a cross-over design is proposed. A cross-over design would also enhance the statistical power of the study, achieving the same statistical power with fewer patients.