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

Publication ,  Journal Article
Haller, JA; Stalmans, P; Benz, MS; Gandorfer, A; Pakola, SJ; Girach, A; Kampik, A; Jaffe, GJ; Toth, CA; MIVI-TRUST Study Group
Published in: Ophthalmology
January 2015

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.

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Published In

Ophthalmology

DOI

EISSN

1549-4713

Publication Date

January 2015

Volume

122

Issue

1

Start / End Page

117 / 122

Location

United States

Related Subject Headings

  • Young Adult
  • Vitreous Body
  • Visual Acuity
  • Treatment Outcome
  • Tomography, Optical Coherence
  • Retinal Diseases
  • Peptide Fragments
  • Ophthalmology & Optometry
  • Middle Aged
  • Male
 

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Haller, J. A., Stalmans, P., Benz, M. S., Gandorfer, A., Pakola, S. J., Girach, 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
Haller, Julia A., Peter Stalmans, Matthew S. Benz, Arnd Gandorfer, Stephen J. Pakola, Aniz Girach, Anselm Kampik, Glenn J. Jaffe, Cynthia A. Toth, and MIVI-TRUST Study Group. “Efficacy of intravitreal ocriplasmin for treatment of vitreomacular adhesion: subgroup analyses from two randomized trials.Ophthalmology 122, no. 1 (January 2015): 117–22. https://doi.org/10.1016/j.ophtha.2014.07.045.
Haller JA, Stalmans P, Benz MS, Gandorfer A, Pakola SJ, Girach A, et al. Efficacy of intravitreal ocriplasmin for treatment of vitreomacular adhesion: subgroup analyses from two randomized trials. Ophthalmology. 2015 Jan;122(1):117–22.
Haller, Julia A., et al. “Efficacy of intravitreal ocriplasmin for treatment of vitreomacular adhesion: subgroup analyses from two randomized trials.Ophthalmology, vol. 122, no. 1, Jan. 2015, pp. 117–22. Pubmed, doi:10.1016/j.ophtha.2014.07.045.
Haller JA, Stalmans P, Benz MS, Gandorfer A, Pakola SJ, Girach A, Kampik A, Jaffe GJ, Toth CA, MIVI-TRUST Study Group. Efficacy of intravitreal ocriplasmin for treatment of vitreomacular adhesion: subgroup analyses from two randomized trials. Ophthalmology. 2015 Jan;122(1):117–122.
Journal cover image

Published In

Ophthalmology

DOI

EISSN

1549-4713

Publication Date

January 2015

Volume

122

Issue

1

Start / End Page

117 / 122

Location

United States

Related Subject Headings

  • Young Adult
  • Vitreous Body
  • Visual Acuity
  • Treatment Outcome
  • Tomography, Optical Coherence
  • Retinal Diseases
  • Peptide Fragments
  • Ophthalmology & Optometry
  • Middle Aged
  • Male