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Baruch Kuppermann, MIVI-TRUST Study Group; Impact of Ocriplasmin Therapy in Symptomatic Vitreomacular Adhesion (VMA) Patients Considered to be Clinical Candidates for Vitrectomy. Invest. Ophthalmol. Vis. Sci. 2013;54(15):1942.
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To evaluate efficacy and safety of ocriplasmin versus placebo for pharmacologic VMA resolution in the subset of eyes considered to be clinical candidates for vitrectomy.
The ocriplasmin phase 3 program included symptomatic patients with OCT-confirmed VMA who were randomized to receive a single intravitreal injection of 125 µg ocriplasmin (n=464) or placebo (n=188). Clinical criteria for consideration for vitrectomy in this subset analysis was visual acuity (VA) of 65 ETDRS letters (20/50) or less (n=301) or full-thickness macular hole (FTMH, equivalent to stage II) (n=153) at baseline. A total of 127 patients met both criteria. In patients without baseline FTMH we evaluated the rate of VMA resolution at 28 days post-injection. In patients with baseline FTMH, VMA resolution and FTMH closure at day 28 were evaluated.
Pharmacologic VMA resolution at day 28 was observed in a significantly larger proportion of eyes in the ocriplasmin group compared to placebo. Among patients with a baseline VA of 65 letters or less, 33.2% of eyes treated with ocriplasmin achieved VMA resolution compared with 11.5% in the placebo group (P<0.001). In patients with a baseline FTMH, these rates were 50.0% and 25.5% (P=0.006), respectively, and correlated with a FTMH closure rate of 40.6% in the ocriplasmin group and 10.1% in the placebo group (P<0.001). Mean baseline ETDRS scores were 53.3/54.8 (≤65 letters/FTMH) in the ocriplasmin groups and 56.3/58.7 (≤65 letters/FTMH) in the placebo groups. Greater changes in mean BCVA were seen in both VMA and FTMH ocriplasmin groups, +6.6/+6.8 ETDRS letters, compared placebo, +3.7/+2.3 ETDRS letters, at month 6 (P=0.114/P=0.086). Achievement of ≥2-line BCVA gain at month 6 occurred in a greater proportion of the VMA/FTMH ocriplasmin groups (43.0%/44.3%) compared to placebo (28.7%/30.4%; P=0.018/P=0.104). BCVA improvement of ≥3 lines was greater in the ocriplasmin groups (25.2%/27.4%) compared to placebo (10.3%/13.0%; P=0.003/P=0.063). Most suspected treatment-related adverse events were mild, non-serious, and occurred within 7 days post-injection. No cases of endophthalmitis were reported.
Treatment with a single intravitreal injection of ocriplasmin was effective in symptomatic VMA patients who would commonly be considered candidates for vitrectomy (VA ≤20/50 or presence of FTMH at baseline).
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