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

Authors

• Julia A Haller
• Peter Stalmans
• Matthew S Benz
• Arnd Gandorfer
• Stephen J Pakola
• Aniz Girach
• Anselm Kampik
• Glenn J Jaffe
• Cynthia A Toth

Publication/Presentation Date

1-1-2015

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.

Volume

122

Issue

1

First Page

117

Last Page

122

ISSN

1549-4713

Published In/Presented At

Haller, J. A., Stalmans, P., Benz, M. S., Gandorfer, A., Pakola, S. J., Girach, A., Kampik, A., Jaffe, G. J., Toth, C. A., & MIVI-TRUST Study Group (2015). Efficacy of intravitreal ocriplasmin for treatment of vitreomacular adhesion: subgroup analyses from two randomized trials. Ophthalmology, 122(1), 117–122. https://doi.org/10.1016/j.ophtha.2014.07.045

Disciplines

Business Administration, Management, and Operations | Health and Medical Administration | Management Sciences and Quantitative Methods

PubMedID

25240630

Department(s)

Administration and Leadership

Document Type

Article