To prospectively investigate the change of clinical manifestations after 1 year of administration of anthocyanoside (Tagen-F®) to patients with NPDR-associated macular edema.

One hundred seventy-five eyes in 88 patients were enrolled in this study, at 5 centers, from March, 2005 to October, 2005. Patients took 3 capsules of Vaccinium myrtillus extract (170 mg/capsule, Tagen-F®, Kukje pharmaceutical) per day. The primary endpoints were corrected visual acuity and contrast sensitivity which were checked at 2 months following the beginning of treatment [East 1]. The secondary endpoints were the number of hard exudates, microaneurysms, leaking points and the changes of foveal thickness. These were examined at the beginning of, 6 months after, and 12 months after treatment.

Corrected visual acuity showed no significant changes during 12 months. Contrast sensitivity improved gradually, especially in 12, 16 cycles per degree [East 2]. There was no statistically significant changes in the numbers of hard exudates, microaneurysms, and leaking points. Foveal thickness measured by OCT was maintained and there was no aggravation of macular edema.

There was marked improvement of contrast sensitivity in patients with NPDR after 1 year of administration of anthocyanoside (Tagen-F®), and it might contribute to the quality of vision and the satisfaction of patients. Visual acuity and macular edema were maintained without aggravation.