Fig. 1.

Study design, including diagram of dose escalation phase. Mock dose escalation was performed in the placebo arm to maintain masking. Subjects who did not tolerate dose escalations could return to the last tolerated dose, but a dose reduction could be undertaken only once and only during weeks 2, 3, or 4. After week 4, all subjects were held at a stable dose. DME, diabetic macular edema; PDR, proliferative diabetic retinopathy; qPM, taken every evening