PURPOSE: To assess efficacy and safety of sarilumab, a human anti-interleukin-6 receptor antibody, for treatment of posterior segment noninfectious uveitis (NIU). DESIGN: Randomized, double-masked, placebo-controlled, phase 2 study. PARTICIPANTS: Fifty-eight patients (eyes) with noninfectious intermediate, posterior, or panuveitis. METHODS: Eyes received treatment every 2 weeks for 16 weeks with subcutaneous sarilumab 200 mg or placebo. MAIN OUTCOME MEASURES: The primary end point was the proportion of patients with ≥2-step reduction in vitreous haze (VH) on the Miami scale or with a reduction of systemic corticosteroids (prednisolone or equivalent) to a dose of <10 mg/day at week 16. Primary end point was based on VH evaluation by a central reading center. Investigator evaluation of VH was a prespecified, planned secondary analysis. RESULTS: At week 16, proportion of patients taking sarilumab or placebo with ≥2-step reduction in VH or corticosteroid dose <10 mg/day was 46.1% vs. 30.0% (P = 0.2354) based on central reading center assessment of VH and 64.0% vs. 35.0% (P = 0.0372) based on investigator assessment of VH, respectively. In the subgroup of eyes with VH grade ≥2 at baseline, the mean VH reduction from baseline to week 16 was significantly greater with sarilumab vs. placebo regardless of assessment by the central reading center (-2.1 [n = 11] vs. -1.7 [n = 3], respectively; P = 0.0255) or investigator (-2.5 [n = 19] vs. -1.2 [n = 11], respectively; P = 0.0170). The mean best-corrected visual acuity gain from baseline to week 16 was greater with sarilumab vs. placebo in the overall population (8.9 vs. 3.6 letters, respectively; P = 0.0333) and in the subgroup of eyes with central subfield thickness (CST) ≥300 μm at baseline (12.2 [n = 13] vs. 2.1 [n = 7] letters, respectively; P = 0.0517). Corresponding changes in CST were -46.8 vs. +2.6 μm (P = 0.0683) in the overall population and -112.5 [n = 13] vs. -1.8 [n = 6] μm (P = 0.1317) in the subgroup of eyes with CST ≥300 μm at baseline, respectively. The most common ocular adverse events were worsening of uveitis (0 [placebo] and 3 [sarilumab] patients) and retinal infiltrates (1 [placebo] and 2 [sarilumab] patients). CONCLUSIONS: Subcutaneous sarilumab may provide clinical benefits in the management of NIU of the posterior segment, especially in eyes with uveitic macular edema.

• MeSH
• antirevmatika škodlivé účinky   terapeutické užití   MeSH
• dospělí MeSH
• dvojitá slepá metoda MeSH
• humanizované monoklonální protilátky škodlivé účinky   terapeutické užití   MeSH
• injekce intravitreální MeSH
• lidé středního věku MeSH
• lidé MeSH
• makulární edém diagnóza   farmakoterapie   patofyziologie   MeSH
• výsledek terapie MeSH
• zadní uveitida diagnóza   farmakoterapie   patofyziologie   MeSH
• zraková ostrost fyziologie   MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky, fáze II MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH
• Názvy látek
• antirevmatika MeSH
• humanizované monoklonální protilátky MeSH
• sarilumab MeSH Prohlížeč

OBJECTIVE: The purpose of the study was to evaluate the results of retreatment for low myopia after primary photorefractive keratectomy (PRK). DESIGN: A prospective study. PARTICIPANTS: A total of 48 eyes of 37 patients from 566 eyes of 331 patients originally treated for myopia of up to -6 diopters (D) were studied. INTERVENTION: Photorefractive keratectomy by the Coherent Schwind Keratom II excimer laser was performed. MAIN OUTCOME MEASURES: The parameters evaluated were visual acuity, refraction, and corneal clarity. RESULTS: Of the 566 eyes with myopia up to -6 D, 48 eyes (8.5%) required retreatment. The sphere (mean +/- standard deviation) was -0.88 +/- 1.24 D before second surgery. At 6 months, the mean was -0.04 +/- 0.91; at 1 year, it was -0.33 +/- 0.75 D. At 6 months, 75% of sphere value was within +/- 1 D. The preoperative uncorrected visual acuity (UCVA) was 20/200 or worse in 12.8% of eyes and 20/40 or better in 40.4% of eyes. Six months after reoperation, 20/60 UCVA was obtained in 17.4% of eyes. All others (82.6%) had UCVA of 20/40 or better, 26.1% better than 20/20. The proportion of eyes with best spectacle-corrected visual acuity better than 20/20 decreased from 60.0% to 47.1% 6 months after reoperation. Six months after reoperation, haze 1 was present in 42.9% and haze 2 in 4.7% of eyes, and in no eye was haze worse. CONCLUSION: Retreatment after PRK for low myopia can significantly increase UCVA and decrease residual refractive error without significant complications.

• MeSH
• astigmatismus chirurgie   MeSH
• dospělí MeSH
• fotorefrakční keratektomie * MeSH
• lasery excimerové MeSH
• lidé středního věku MeSH
• lidé MeSH
• myopie chirurgie   MeSH
• prospektivní studie MeSH
• refrakce oka MeSH
• reoperace MeSH
• rohovka chirurgie   MeSH
• výsledek terapie MeSH
• zákal rohovky patofyziologie   MeSH
• zraková ostrost MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH