STUDY SUBJECTS

Major Inclusion criteria:

• Foveal thickness of 250μm or more despite at least 1 prior focal/grid macular laser photocoagulation treatment
• Best corrected visual acuity (BCVA) between 20/50 – 20/400

STUDY INTERVENTIONS

• 956 subjects were randomized in a 2:2:1 ratio of 0.2μg/day FA intravitreal insert, 0.5μg/day of FA intravitreal insert, or sham injection.
• Subjects were eligible for retreatment after month 12 if they experienced loss of > 5 letters in BCVA or an increase in foveal thickness of 50 μm or more compared with the subject’s best status during the previous 12 months.
• Primary outcome: Percentage of subjects with improvement from baseline BCVA of 15 letters or more at month 24.

RESULTS

Study population

• Treatment groups were balanced with respect to age, race, mean duration of diabetes, mean duration of DME, and mean BCVA, and foveal thickness.

Visual acuity end-points

• Percentage of patients with a gain of 15 letters or more from baseline at month 24 was 28.7% and 28.6% in the low- and high-dose FA insert groups, respectively, compared with 16.2% in the sham group.

The mean improvement in BCVA was 5 letters at 3 weeks after either FA insert, increased to 6 letters at 6 weeks after injection, and stayed at that level through the 6 month time point.

Anatomic outcomes

• At month 24, the percentage of patients with foveal thickness less than 250 μm was 51% in the low-dose group, 47% in the high-dose group, and 40% in the sham group.

Adverse Events

• Cataract surgery occurred in 41% in the low-dose group, 51% in the high-dose group, and 7% in the sham group.
• Incisional glaucoma surgery was performed in 8.1% in the high-dose group, 3.7% in the low-dose group, and 0.5% in the sham group.

CONCLUSIONS

• Intravitreal fluocinolone acetonide implants significantly improved visual acuity in patients with diabetic macular edema over 2 years and had a favorable risk-to-benefit ratio with the low dose concentration.