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S. Yeh, K. K. Wroblewski, R. Buggage, Z. Li, S. K. Kurup, H. N. Sen, S. Dahr, J. Ragheb, T. A. Waldmann, R. B. Nussenblatt; Daclizumab for Active, Non-Infectious, Sight-Threatening Uveitis: A Phase II Pilot Study. Invest. Ophthalmol. Vis. Sci. 2008;49(13):3891.
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This study was designed to provide preliminary data regarding the safety and efficacy of high-dose humanized anti-IL-2 receptor (daclizumab) therapy for the treatment of active intermediate, posterior or panuveitis.
Five patients were recruited into this non-randomized, prospective pilot study of high-dose intravenous induction daclizumab therapy (8 mg/kg at day 0, 4 mg/kg at day 14). Patients who did not meet a safety endpoint at the 3-week follow-up were given the option of continuing therapy with subcutaneous daclizumab 2 mg/kg for 52 weeks. The primary outcome assessed was a 2-step decrease in vitreous haze at the day 21 follow-up visit. Secondary outcomes included visual acuity, cystoid macular edema, retinal vascular sheathing leakage by fluorescein angiography, anterior chamber and vitreous cellular inflammation, and vitreous haze.
4 male patients and 1 female patient were enrolled. Diagnoses included birdshot retinochoroidopathy (2 pts), Vogt-Koyanagi-Harada’s disease, bilateral idiopathic panuveitis and bilateral idiopathic intermediate uveitis. By week 4, four of five patients demonstrated a 2-step decrease in vitreous haze. One participant did not meet this criteria until week 20, but all 5 patients maintained stability in vitreous haze grade throughout their follow-up periods. At enrollment, mean visual acuity (10 eyes in five patients) was 69.2 ETDRS letters and following treatment was 78.2 letters (p=0.08). Anterior chamber cell, vitreous cell, and vitreous haze also improved in the majority of eyes. Specifically, anterior chamber cells decreased in 8 of 9 eyes (88%), vitreous cell decreased in 6 of 10 eyes (60%) and vitreous haze decreased in 8 of 8 eyes. Adverse events were generally mild except for one episode of left-lower lobe pneumonia requiring hospitalization and treatment.
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