June 2013
Volume 54, Issue 15
ARVO Annual Meeting Abstract  |   June 2013
Impact of Ocriplasmin Therapy in Symptomatic Vitreomacular Adhesion (VMA) Patients Considered to be Clinical Candidates for Vitrectomy
Author Affiliations & Notes
  • Baruch Kuppermann
    Gavin Herbert Eye Inst Dept Ophthal, University of California Irvine, Irvine, CA
  • Footnotes
    Commercial Relationships Baruch Kuppermann, Alimera (C), Allegro (C), Allergan (C), Genentech (C), Glaukos (C), GSK (F), Novagali (C), Novartis (C), Ophthotech (C), Pfizer (C), Regeneron (C), Santen (C), SecondSight (C), Teva (C), ThromboGenics (C)
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science June 2013, Vol.54, 1942. doi:https://doi.org/
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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. doi: https://doi.org/.

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      © ARVO (1962-2015); The Authors (2016-present)

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Purpose: 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.

Methods: 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.

Results: 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.

Conclusions: 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).

Keywords: 688 retina • 692 retinal adhesion • 762 vitreoretinal surgery  

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