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Intravitreal insert provides substantial long-term benefit in DME patients
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Fluocinolone acetonide intravitreal inserts substantially improved visual acuity for up to 3 years in patients with diabetic macular edema, according to the FAME studies.
In the two sham injection-controlled clinical trials, 953 subjects with persistent DME were randomized to receive a sham injection or a low-dose or high-dose fluocinolone acetonide intravitreal insert (Alimera).
At 36 months after injection, best corrected visual acuity was improved by 15 letters or more in 28.7% of low-dose subjects and 27.8% of high-dose subjects compared with 18.9% of subjects in the sham group (P = .018 for difference between low-dose group and sham group).
Cataract developed in almost all phakic patients in the fluocinolone acetonide groups, but the visual benefit after cataract surgery was similar to that in patients who were pseudophakic at baseline.
“In patients with persistent DME, the relative benefits of [fluocinolone acetonide] inserts would make it reasonable to consider [fluocinolone acetonide] inserts earlier in the treatment regimen because there seems to be functional benefit that is out of proportion to the anatomic benefit,” the study authors said.
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