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Relation between ocriplasmin-induced anatomic and visual function response

Poster Details

First Author: T.Jackson UK

Co Author(s):    T. Verstraeten   L. Duchateau   B. Lescrauwaet        

Abstract Details



Purpose:

Intravitreal ocriplasmin is indicated for the treatment of vitreomacular traction, including when associated with full-thickness macular holes ≤400 μm. In two phase III clinical trials, ocriplasmin induced a higher rate of vitreomacular adhesion (VMA) release than a control saline injection, but it is not known how this anatomic outcome measure corresponds to functional visual gain. We aimed to study the relationship between VMA release and visual function.

Setting:

The setting of the two multicenter phase III clinical trials included 89 sites in Europe and the USA.

Methods:

The two double-masked, placebo-controlled, pivotal trials randomized 652 participants to 125 μg intravitreal ocriplasmin (n = 464) and or saline injection (n = 188). The primary outcome was an anatomic response, defined as non-surgical, complete resolution of VMA by day 28. Because visual acuity (VA) may not fully measure the vision impairment experienced with vitreomacular traction or macular hole, the National Eye Institute visual function questionnaire-25 (VFQ-25) was also used at baseline and 6 months. In a post hoc analysis, visual functional response (VFR) was defined as either: non-surgical VA gain of ≥ 2 lines; clinically meaningful improvement in the VFQ-25 composite score (minimal clinically important difference, MCID >3.6); or driving subscale (MCID >19.1). We defined complete-responders as participants who had both an anatomic response (VMA release at day 28) and VFR. Visual-function-only-responders, or anatomic-only-responders, were participants who improved in either category (but not both), and nonresponders (NR) had no improvement in either category. We investigated the ocriplasmin versus placebo effect for each of these response categories using generalized logit regression models with odds ratios, with the nonresponder group as baseline category.

Results:

Compared to placebo, the ocriplasmin group had increased VMA resolution at day 28 (26.5% vs 10.1%, p<0.001) and more eyes with ≥ 2-line improvement at month 6 (23.7% versus 11.2%, p<0.001). Comparing the ocriplasmin and placebo group respectively, the proportion of complete-responders was 18.3% versus 5.2% (p= 0.003); visual-function-only responders, 36.8% versus 29.0% (p=0.0007); and anatomic-only-responders 10.2% versus 5.2% (p<0.0001). Ocriplasmin treatment produced a VFR, either alone or in combination with an anatomic response, in 55.1% of participants, compared to 34.2% for placebo. There was significant improvement in the mean VFQ-25 composite score (3.4 vs 0.7, p=0.005) as well as the driving subscale (2.7 vs -1.5; p=0.027) with ocriplasmin treatment compared to placebo. VMA resolution status on day 28 was also a predictor of a VFR.

Conclusions:

In all three responder categories (complete, anatomical, and visual functional), ocriplasmin-treated participants did better than controls, regardless of the outcome measure (VA, VFQ-25 composite score, VFQ-25 driving subscale score, and overall VFR). Participants achieving the primary endpoint of non-surgical VMA resolution at day 28 also had a better VFR. The reason why the visual function response was larger than the anatomic response in the ocriplasmin treated group is not known, but the possibility of partial release of VMA positively affecting visual function warrants further investigation. FINANCIAL INTEREST: One of more of the authors... travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented

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