Improvement in Patient-Reported Visual Function After Ocriplasmin for Vitreomacular Adhesion: Results of the Microplasmin for Intravitreous Injection-Traction Release Without Surgical Treatment (MIVI-TRUST) Trials.

Publication/Presentation Date

9-1-2015

Abstract

IMPORTANCE: The impact of vitreomacular adhesion (VMA) resolution on patient-reported visual function in symptomatic VMA/vitreomacular traction (VMT) has not yet been documented, to our knowledge.

OBJECTIVE: To determine the impact of intravitreal ocriplasmin on patient-reported visual function using the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) during a 6-month follow-up in patients with symptomatic VMA.

DESIGN, SETTING, AND PARTICIPANTS: Two multicenter, randomized, masked, phase 3 clinical trials (studies TG-MV-006 [between December 2008 and April 2010] and TG-MV-007 [between December 2008 and July 2010]) at clinic-based centers in the United States and Europe. A total of 652 patients with symptomatic VMA/VMT, including when associated with a macular hole 400 μm or smaller, were studied. Analysis was by intent-to-treat population and performed in May 2013.

INTERVENTIONS: Patients with symptomatic VMA/VMT were randomly assigned (2:1 or 3:1 in study TG-MV-006 and study TG-MV-007, respectively) to receive a single intravitreal injection of ocriplasmin, 125 μg, or placebo-injected vehicle (placebo). The NEI VFQ-25 was administered at baseline and 6 months following ocriplasmin injection.

MAIN OUTCOMES AND MEASURES: Mean changes between baseline and 6-month follow-up NEI VFQ-25 composite and subscale scores and the proportion of patients with a clinically meaningful change (≥5 points) in scores.

RESULTS: Across the 2 studies, 464 patients received ocriplasmin and 188 received placebo. At 6 months, the ocriplasmin group reported greater mean improvements from baseline in the NEI VFQ-25 composite score than the placebo group (mean change, 3.4 vs 0.7, respectively; P = .005). Improvements were also noted in subscale scores, with the following respective mean changes for the ocriplasmin vs placebo groups: vision-related dependency, 1.7 vs -2.1 (P = .009); driving difficulty, 2.7 vs -1.5 (P = .03); distance vision activities, 4.1 vs 0.8 (P = .03); and general vision, 6.1 vs 2.1 (P = .003). A higher proportion of the ocriplasmin group had a clinically meaningful (≥5-point) improvement in NEI VFQ-25 composite score from baseline than the placebo group (36.0% vs 27.2%, respectively; P = .03). Fewer ocriplasmin-treated patients had a clinically meaningful worsening in their visual function than the placebo group (15.0% vs 24.3%, respectively; P = .005). Changes in NEI VFQ-25 composite score and various subscale scores were observed in ocriplasmin-treated patients who achieved VMA resolution at day 28.

CONCLUSIONS AND RELEVANCE: Ocriplasmin produces clinically meaningful improvement in patient-reported visual function in symptomatic VMA/VMT.

TRIAL REGISTRATION: clinicaltrials.gov Identifiers: NCT00781859 and NCT00798317.

Volume

133

Issue

9

First Page

997

Last Page

1004

ISSN

2168-6173

Disciplines

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

PubMedID

26068086

Department(s)

Administration and Leadership

Document Type

Article

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