期刊
OPHTHALMOLOGY
卷 122, 期 1, 页码 117-122出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.ophtha.2014.07.045
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资金
- ThromboGenics
Purpose: To evaluate the efficacy of a single intravitreal injection of ocriplasmin 125 mu g across relevant subpopulations of patients with symptomatic vitreomacular adhesion (VMA)/vitreomacular traction (VMT), including when associated with macular hole. Design: Two multicenter, randomized, placebo-controlled, double-masked, 6-month studies. Participants: A total of 652 randomized patients (464 receiving ocriplasmin; 188 receiving placebo). Methods: A single intravitreal injection of ocriplasmin 125 mg or placebo in the study eye. Main Outcome Measures: Prespecified subgroup analyses were conducted to evaluate the effects on the proportion of patients with nonsurgical resolution of focal VMA at day 28, nonsurgical full-thickness macular hole (FTMH) closure at month 6, and categoric improvement in best-corrected visual acuity (BCVA) at month 6. Results: Resolution of VMA at day 28 was achieved more often in younger patients (< 65 years), eyes without epiretinal membrane, eyes with FTMH, phakic eyes, and eyes with a focal VMA <= 1500 mu m. Eyes with FTMH width <= 250 mu m were more likely to achieve nonsurgical FTMH closure. Categoric >= 2-line and >= 3-line improvement in BCVA occurred more often in younger patients (< 65 years) and in patients with a lower baseline BCVA (< 65 letters). Treatment differences in favor of ocriplasmin were generally observed across each subgroup of subpopulations studied. Conclusions: Subgroup analyses confirmed the positive effect of ocriplasmin across relevant subpopulations. (C) 2015 by the American Academy of Ophthalmology.
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