Visual function response to ocriplasmin for the treatment of vitreomacular traction: results from the oasis study

T.l. Jackson, B. Lescrauwaet, L. Duchateau, T. Verstraeten

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Abstract

Purpose

The effect of an intravitreal ocriplasmin-injection on vitreomacular adhesion (VMA) resolution was investigated in a phase 3b randomized, sham-controlled, double-masked, multicentre study. The objective of this analysis was to assess the effect of ocriplasmin on patient-relevant visual function outcomes.

Methods

Prespecified analysis of secondary endpoints in the OASIS study. A total of 220 participants with symptomatic VMA/VMT were enrolled, of whom 146 received a single IVT-injection of 125 μg ocriplasmin and 74 a sham-injection. Visual function response (VFR) was defined as either a VA improvement of ≥2 lines or an improvement exceeding the minimal clinically important difference (MCID) in the composite score or the VFQ-25 mental health subscale score of the Visual Function Questionnaire (VFQ-25). The MCID was estimated using the standard error of measurement approach. The main outcome measure was the VFR at 6 months, with further assessments at month 12 and 24.

Results

The MCID was estimated at 3.71 points for the VFQ-25 composite score and 10.71 for the VFQ-25 mental health subscale score. VFR occurred in 51.0% of ocriplasmin vs. 23.3% of sham subjects (p = 0.0001). The VFR was maintained through months 12 and 24: 53.1% and 50.3% in ocriplasmin vs. 21.9% and 20.5% in sham subjects, respectively (p < 0.0001).

Conclusions

Treatment with ocriplasmin compared with sham resulted in a significant improvement in VFR. The 6-month treatment effect was sustained at month 12 and 24.

Original languageEnglish
JournalActa Ophthalmologica
Volume94
Early online date14 Sept 2016
DOIs
Publication statusPublished - Oct 2016

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