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S. M. Whitcup, S. Lightman, R. Belfort, C. Y. Lowder, C. Foster, M. R. Robinson, R. M. Schiffman, X.-Y. Li, H. Cui; Double-Masked, Sham-Controlled, Randomized Study of Dexamethasone Intravitreal Implant for the Treatment of Uveitis. Invest. Ophthalmol. Vis. Sci. 2010;51(13):6381.
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To evaluate the a dexamethasone intravitreal implant(OZURDEXTM) in patients with uveitis.
In this 26-week trial, patients with noninfectious, intermediate, or posterior uveitis were randomized to receive DEX Implant 700µg (n=77), DEX Implant 350µg (n=76), or sham (n=76). The primary endpoint was the proportion of patients with vitreous haze score of 0 at Week 8. Other endpoints included best-corrected visual acuity (BCVA) and safety.
The proportion of patients with a vitreous haze score of 0 at week 8 was 46.8% with DEX Implant 700µg, 35.5% with DEX Implant 350µg, and 11.8% with sham (P<.001); this benefit persisted through week 26. A gain of ≥15 letters from baseline BCVA was seen in significantly more patients in the DEX Implant groups than the sham group at all study visits; at week 8, 42.9% in the DEX Implant 700µg group, 39.5% in DEX Implant 350µg group, and 6.6% in sham group (P<.001). Overall, the 700µg dose was more effective than 350µg dose. The percentage of patients with IOP ≥25 mmHg peaked at 7.1% for DEX Implant 700µg, 8.7% for DEX Implant 350µg, and 4.2% for sham (no statistically significant between-group difference at any visit). Cataracts were reported as adverse events in 11/76 DEX Implant 700µg patients, 10/74 DEX Implant 350µg patients, and 8/75 sham patients (P=.769).
In patients with non-infectious intermediate or posterior uveitis, a single dose of DEX Implant was well-tolerated and produced significant improvements in intraocular inflammation and visual acuity persisting for 6 months. Overall, DEX Implant 700µg demonstrated greater efficacy than DEX Implant 350µg with similar safety.
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