Baseline characteristics predictive of pharmacologic vitreomacular adhesion resolution in the ocriplasmin MIVI-TRUST program

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Abstract

Purpose

The ocriplasmin MIVI-TRUST program included two phase III, multicenter, randomized, double-masked trials to determine the efficacy and safety of ocriplasmin for the treatment of vitreomacular traction (VMT). We sought to identify baseline characteristics that were predictive of pharmacologic vitreomacular adhesion (VMA) resolution at Day 28 after an injection of ocriplasmin or placebo.

Methods

Patients with OCT-confirmed VMA were randomized to receive a single intravitreal injection of ocriplasmin 125 μg (n=464) or placebo (n=188). The primary end point was VMA resolution at 28 days post-injection. A multivariate regression analysis was performed to determine independent baseline anatomic and non-anatomic characteristics that were significantly associated with pharmacologic VMA at Day 28.

Results

Pharmacologic VMA resolution at Day 28 was observed in a significantly larger proportion of patients in the ocriplasmin group (26.5%) compared with placebo (10.1%; p<0.001). Independent baseline anatomic characteristics predictive of VMA resolution included the presence of a full-thickness macular hole (equivalent to stage II; p=0.019), VMA diameter ≤1500 μm (p<0.001), phakic lens status (p<0.001), and the absence of an epiretinal membrane (p<0.001). Independent non-anatomic baseline characteristics predictive of VMA resolution included treatment with ocriplasmin (p<0.001) and age <65 years (p<0.001).

Conclusion

The identification of specific baseline anatomic characteristics predictive of response is informative in the consideration of treatment options for patients with VMT.

Conclusion

Commercial interest

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