Association between anatomical resolution and functional outcomes in the mivi-trust studies using ocriplasmin to treat symptomatic vitreomacular adhesion/vitreomacular traction, including when associated with macular hole.

Authors

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

Publication/Presentation Date

6-1-2015

Abstract

PURPOSE: To evaluate visual function in patients with symptomatic vitreomacular adhesion (VMA)/vitreomacular traction including when associated with macular hole after ocriplasmin treatment, and the association between resolution of the underlying condition and improvement in visual function.

METHODS: Six hundred and fifty-two patients from 2 Phase 3 trials received a single intravitreal injection of ocriplasmin 125 μg (n = 464) or placebo (n = 188). Mean and categorical changes from baseline in best-corrected visual acuity and 25-item Visual Function Questionnaire scores were used to evaluate visual function. Subgroups with VMA resolution and full-thickness macular hole closure were compared.

RESULTS: Overall, 42% of patients who achieved VMA resolution at Day 28 had a ≥2-line improvement in best-corrected visual acuity at Month 6, and 20% had a ≥3-line improvement. Likewise, 69% of patients with nonsurgical full-thickness macular hole closure at Day 28 had a ≥2-line improvement at Month 6, and 48% had a ≥3-line best-corrected visual acuity improvement. Mean improvements in 25-item Visual Function Questionnaire scores were associated with achieving VMA resolution and nonsurgical full-thickness macular hole closure.

CONCLUSION: In patients with symptomatic VMA/vitreomacular traction, VMA resolution and nonsurgical full-thickness macular hole closure were each associated with improvements in visual function. Resolving the underlying anatomical condition in symptomatic VMA/vitreomacular traction will increase the probability of achieving a clinically meaningful improvement in visual function.

Volume

35

Issue

6

First Page

1151

Last Page

1157

ISSN

1539-2864

Published In/Presented At

Gandorfer, A., Benz, M. S., Haller, J. A., Stalmans, P., Pakola, S. J., Girach, A., Kampik, A., Toth, C. A., Jaffe, G. J., & MIVI-TRUST Study Group (2015). Association between anatomical resolution and functional outcomes in the mivi-trust studies using ocriplasmin to treat symptomatic vitreomacular adhesion/vitreomacular traction, including when associated with macular hole. Retina (Philadelphia, Pa.), 35(6), 1151–1157. https://doi.org/10.1097/IAE.0000000000000508

Disciplines

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

PubMedID

25741816

Department(s)

Administration and Leadership

Document Type

Article