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Ophthalmology. 2015 Jan;122(1):117-22. doi: 10.1016/j.ophtha.2014.07.045. Epub 2014 Sep 18.

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

Author information

1
Wills Eye Hospital, Philadelphia, Pennsylvania. Electronic address: jhaller@willseye.org.
2
Department of Ophthalmology, UZ Leuven, Leuven, Belgium.
3
Retina Consultants of Houston, Houston, Texas.
4
Department of Ophthalmology, Klinikum der LMU, Munich, Germany and MVZ, Memmingen, Munich, Germany.
5
Amakem NV, Diepenbeek, Belgium (formerly of ThromboGenics NV).
6
NightstaRx Ltd, London, UK (formerly of ThromboGenics NV).
7
Department of Ophthalmology, Klinikum der LMU, Munich, Germany.
8
Duke Reading Center, Duke University School of Medicine, Durham, North Carolina.

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.

PMID:
25240630
DOI:
10.1016/j.ophtha.2014.07.045
[Indexed for MEDLINE]

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