ObjectiveTo evaluate the safety and efficacy of 2 doses of dexamethasone intravitreal implant (DEX implant) for treatment of noninfectious intermediate or posterior uveitis.MethodsIn this 26-week trial, eyes with noninfectious intermediate or posterior uveitis were randomized to a single treatment with a 0.7-mg DEX implant (n = 77), 0.35-mg DEX implant (n = 76), or sham procedure (n = 76).Main Outcome MeasureThe main outcome measure was the proportion of eyes with a vitreous haze score of 0 at week 8.ResultsThe proportion of eyes with a vitreous haze score of 0 at week 8 was 47% with the 0.7-mg DEX implant, 36% with the 0.35-mg DEX implant, and 12% with the sham (P < .001); this benefit persisted through week 26. A gain of 15 or more letters from baseline best-corrected visual acuity was seen in significantly more eyes in the DEX implant groups than the sham group at all study visits. The percentage of eyes with intraocular pressure of 25 mm Hg or more peaked at 7.1% for the 0.7-mg DEX implant, 8.7% for the 0.35-mg DEX implant, and 4.2% for the sham (P > .05 at any visit). The incidence of cataract reported in the phakic eyes was 9 of 62 (15%) with the 0.7-mg DEX implant, 6 of 51 (12%) with the 0.35-mg DEX implant, and 4 of 55 (7%) with the sham (P > .05).ConclusionsIn patients with noninfectious intermediate or posterior uveitis, a single DEX implant significantly improved intraocular inflammation and visual acuity persisting for 6 months.Application to Clinical PracticeDexamethasone intravitreal implant may be used safely and effectively for treatment of intermediate and posterior uveitis.Trial Registrationclinicaltrials.gov Identifier: NCT00333814
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Dexamethasone intravitreal implant. A, Placement of the dexamethasone intravitreal implant in the vitreous. B, Degradation of the implant over time: at administration (left) and after 3 weeks (right).
Flowchart of patient disposition. DEX implant indicates dexamethasone intravitreal implant.
Eyes with a vitreous haze score of 0. A, All eyes. B, Eyes with a baseline vitreous haze score of +1.5 or +2. C, Eyes with a baseline vitreous haze score of +3 or +4. When significant, P values are shown for the 0.7-mg dexamethasone intravitreal implant (DEX implant) vs sham. *One patient in the 0.7-mg DEX implant group with a baseline vitreous haze score of +1 was excluded from the analysis.
Eyes with at least 2 units of improvement in vitreous haze score. When significant, P values are shown for the 0.7-mg dexamethasone intravitreal implant (DEX implant) vs sham. The differences between the 0.35-mg DEX implant group and the sham group were statistically significant at week 3 (P = .034) and weeks 6 to 26 (P ≤ .003).
Best-corrected visual acuity (BCVA). A, Eyes achieving a 15-letter or more improvement from baseline BCVA. B, Change from baseline BCVA. P > .05 for the 0.7-mg vs 0.35-mg dexamethasone intravitreal implant (DEX implant). P values are in comparison with the sham procedure.
Cumulative percentage of eyes requiring rescue medication in the study eye at each visit. P values are for the 0.7-mg dexamethasone intravitreal implant (DEX implant) vs the sham procedure.
Percentage of eyes with notable changes in intraocular pressure (IOP). A, Percentage of eyes with IOP of at least 35 mm Hg. B, Percentage of eyes with IOP of at least 25 mm Hg. DEX implant indicates dexamethasone intravitreal implant.
Intraocular pressure (IOP)–lowering medication use in the 0.7-mg dexamethasone intravitreal implant (DEX implant) group only.
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