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Efficacy of intravitreal ocriplasmin for treatment of vitreomacular adhesion: subgroup analyses from two randomized trials.

Abstract：

PURPOSE:To evaluate the efficacy of a single intravitreal injection of ocriplasmin 125 μg 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 μg 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 μm. Eyes with FTMH width ≤ 250 μm 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.

journal_name

Ophthalmology

journal_title

Ophthalmology

authors

Haller JA,Stalmans P,Benz MS,Gandorfer A,Pakola SJ,Girach A,Kampik A,Jaffe GJ,Toth CA,MIVI-TRUST Study Group.

doi

10.1016/j.ophtha.2014.07.045

subject

Has Abstract

pub_date

2015-01-01 00:00:00

pages

117-22

issue

1

eissn

0161-6420

issn

1549-4713

pii

S0161-6420(14)00689-7

journal_volume

122

pub_type

杂志文章,多中心研究,随机对照试验

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