Efficacy of Intravitreal Ocriplasmin for Treatment of Vitreomacular Adhesion

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-co...

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Published inOphthalmology (Rochester, Minn.) Vol. 122; no. 1; pp. 117 - 122
Main Authors Haller, Julia A., MD, Stalmans, Peter, MD, PhD, Benz, Matthew S., MD, Gandorfer, Arnd, MD, Pakola, Stephen J., MD, Girach, Aniz, MD, Kampik, Anselm, MD, Jaffe, Glenn J., MD, Toth, Cynthia A., MD
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LanguageEnglish
Published Elsevier Inc 2015
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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.
AbstractList 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.
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. Two multicenter, randomized, placebo-controlled, double-masked, 6-month studies. A total of 652 randomized patients (464 receiving ocriplasmin; 188 receiving placebo). A single intravitreal injection of ocriplasmin 125 μg or placebo in the study eye. 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. 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. Subgroup analyses confirmed the positive effect of ocriplasmin across relevant subpopulations.
Author Jaffe, Glenn J., MD
Pakola, Stephen J., MD
Gandorfer, Arnd, MD
Kampik, Anselm, MD
Stalmans, Peter, MD, PhD
Benz, Matthew S., MD
Girach, Aniz, MD
Toth, Cynthia A., MD
Haller, Julia A., MD
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  fullname: Jaffe, Glenn J., MD
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  fullname: Toth, Cynthia A., MD
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Keywords ERM
OCT
OR
optical coherence tomography
CI
FTMH
odds ratio
VMA
epiretinal membrane
vitreomacular traction
BCVA
posterior vitreous detachment
vitreomacular adhesion
best-corrected visual acuity
confidence interval
full-thickness macular hole
VMT
PVD
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Snippet Purpose To evaluate the efficacy of a single intravitreal injection of ocriplasmin 125 μg across relevant subpopulations of patients with symptomatic...
To evaluate the efficacy of a single intravitreal injection of ocriplasmin 125 μg across relevant subpopulations of patients with symptomatic vitreomacular...
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SubjectTerms Ophthalmology
Title Efficacy of Intravitreal Ocriplasmin for Treatment of Vitreomacular Adhesion
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