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Session Title: Special Cases
Session Date/Time: Monday 07/10/2013 | 17:00-18:30
Paper Time: 17:21
Venue: Elicium 1 (First Floor)
First Author: : A.Gandorfer GERMANY
Co Author(s): :
To determine the effect of pharmacologic VMA resolution or FTMH (equivalent to stage II) closure on VA outcomes in the MIVI TRUST program.
The ocriplasmin MIVI-TRUST program included two phase 3, multicenter, randomized, double-masked, placebo-controlled trials in the EU and the US.
Patients with VMT were randomized to receive a single intravitreal injection of 125 µg ocriplasmin (n=464) or placebo (n=188). The primary end point was anatomic VMA resolution at 28 days post-injection. Selected secondary end points included pharmacologic FTMH closure and best-corrected VA (BCVA) improvement of ?2 or ?3 lines.
Pharmacologic VMA resolution at day 28 was observed in a significantly larger proportion of the ocriplasmin group (26.5%) compared to placebo (10.1%; P<0.001). Pharmacologic FTMH closure at day 28 was observed in a greater proportion of patients in the ocriplasmin group (40.6%) compared to placebo (10.6%). BCVA improvement of ?2 lines at 6 months occurred in 41.5% of responders (ie pharmacologic VMA resolution at 28 days) compared to 20.2% of nonresponders. Respective ?3-line gain rates were 19.7% and 8.1%. BCVA improvement of ?2 lines at 6 months was observed in 68.8% of patients with FTMH closure compared to 26.9% of patients who did not achieve this outcome. Respective ?3-line gain rates were 47.9% and 11.5%.
A single injection of ocriplasmin achieves higher rates of VMA resolution and FTMH closure compared to placebo. BCVA gains at 6 months were greater in patients with who achieved these outcomes compared to those who did not.
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