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목적 : Additional treatment options are needed for DME patients who fail to achieve significant improvement in vision with prior treatment. Therefore, we examined data from a subgroup of patients with prior treatment at MEAD study entry to analyze the effect of DEX at 0.7 mg (DEX-0.7 mg) therapy on these previously treated DME patients.
방법 : This was a three-year, phase III study where DME patients were randomized to DEX-0.7 mg, 0.35 mg, or sham with retreatment up to every 6 months. The outcomes analyzed for the subgroup with prior treatment at study entry were: ≥15-letter gain in best-corrected visual acuity (BCVA) at study end, change from baseline in average BCVA and central retinal thickness (CRT), and adverse events (AEs).
결과 : Overall, 72% (757/1048) of patients were previously treated. Mean injections over 3 years were 4.1 for DEX-0.7 and 3.2 for sham. The data showed that 21.5% of patients receiving DEX-0.7 (n=247) vs 11.1% sham (n=261) had ≥15-letter gain from baseline at study end (P=0.002). Average BCVA change from baseline was +3.2 with DEX-0.7 vs +1.5 letters with sham (P=0.024). Average change from baseline in CRT was -126.1 µm with DEX-0.7 vs -39.0 µm with sham (P<0.001). Cataract-related AEs reported in 70.3% of phakic patients; most recovered their vision post-cataract surgery. Modest Intraocular pressure (IOP) peaks of similar frequency were well-managed with topical therapy. In treatment-naïve patients, 24.0% (25/104) receiving DEX-0.7 vs 14.6% (13/89) sham had ≥15-letter gain from baseline at study end (P=0.096).
결론 : DEX-0.7 significantly improved visual and anatomic outcomes in DME patients previously treated with laser, intravitreal anti-VEGF or corticosteroids, or combination, with a safety profile similar to the overall population. Data suggest DEX has role in treating DME in substantial number of patients failing to respond to standard therapy, and has no cumulative IOP effect.
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