NEW ORLEANS — Dexamethasone provides long-term vision improvement in patients with diabetic macular edema, according to phase 3 study results, a presenter said here.
David S. Boyer, MD, told colleagues at Retina Subspecialty Day preceding the American Academy of Ophthalmology meeting, “There’s great rationale for using dexamethasone; it helps reduce key factors in pathogenesis of diabetic macular edema: angiogenesis, vascular leakage and inflammation.”
The 3-year multicenter, masked, randomized controlled trial was undertaken to assess the safety and efficacy of dexamethasone to treat DME. About 350 patients were randomized to each of three arms of the study: dexamethasone 700 µg, dexamethasone 350 µg or sham delivered by sustained-release implant. Re-treatments were delivered every 6 months for 36 months, if necessary.
The percentage of patients with a 15 or more letter gain was significantly greater in dexamethasone-treated patients than in sham-treated patients at 3 years, which was the primary endpoint, according to the results. Furthermore, treatment benefit was observed with a mean of 4.1 injections over 3 years.
“The safety profile was as good or better than in other studies; overall, longer exposure, as expected, would cause cataract,” Boyer said. “Pressure elevations were manageable and rarely required treatment.”
There was no evidence of incremental systemic adverse events or increased risk of arterial thromboembolic events after repeat treatment, according to the presentation.
Disclosure: Boyer is a consultant and speaker for Allergan.