July 2019
Volume 60, Issue 9
Free
ARVO Annual Meeting Abstract  |   July 2019
Effectiveness of Ocriplasmin In Real-World Settings: A Systematic Literature Review
Author Affiliations & Notes
  • Ryan Constantine
    Sierra Eye Associates, Reno, Nevada, United States
  • Koenraad H Blot
    Xintera bvba, Gent, Belgium
  • Benedicte M Lescrauwaet
    Xintera bvba, Gent, Belgium
  • Arshad M. Khanani
    Sierra Eye Associates, Reno, Nevada, United States
  • Footnotes
    Commercial Relationships   Ryan Constantine, None; Koenraad Blot, Oxurion (C); Benedicte Lescrauwaet, Oxurion (C); Arshad Khanani, Aerpio (F), Aerpio (C), Alimera (C), Allergan (F), Allergan (C), Allergan (R), Clearside Biomedical (F), Genentech (F), Genentech (C), Genentech (R), Notal Vision (C), Novartis (F), Novartis (C), Novartis (R), Ophtea (F), Ophtea (C), Ophtotech (F), Oxurion (F), Oxurion (C), Polyphotonix (C), Recens Medical (C), Roche (C), Santen (C), Verana Health (F)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science July 2019, Vol.60, 2014. doi:https://doi.org/
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      Ryan Constantine, Koenraad H Blot, Benedicte M Lescrauwaet, Arshad M. Khanani; Effectiveness of Ocriplasmin In Real-World Settings: A Systematic Literature Review. Invest. Ophthalmol. Vis. Sci. 2019;60(9):2014. doi: https://doi.org/.

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

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Abstract

Purpose : Ocriplasmin is approved for the treatment of vitreomacular traction (VMT) with or without macular hole (MH) ≤400 µm. Its efficacy was evaluated in 4 randomized controlled trials (RCT). We conducted a systematic literature review (SLR) of ocriplasmin use in clinical practice to evaluate its effectiveness in real-world settings.

Methods : We searched PubMed and EMBASE for studies documenting the effectiveness of ocriplasmin, administered as a single 125µg dose for the treatment of VMT in real-world settings. A minimum follow-up of 28 days was required. RCTs, safety-only reports, conference abstracts and series with <12 patients were excluded. The primary endpoint was the incidence of primary VMA resolution (VMAR) defined as VMAR regardless of subsequent vitrectomy. Secondary endpoints included nonsurgical VMAR, MH closure and the need for vitrectomy. Safety endpoints included incidence of retinal breaks/detachment, dyschromatopsia, ERG abnormalities, subretinal fluid, MH progression, ≥2-line BCVA loss and lens subluxation. Results were analyzed using random effects meta-analysis.

Results : We identified 355 records (93 duplicates), of which 30 (2398 patients) were included. Mean age was 71.3 years, 68.7% were women and 22.1% had MH. Not all endpoints were available for each study. The pooled random effects estimates are shown in Table 1 (effectiveness) and Table 2 (safety outcomes).

Conclusions : The effectiveness of ocriplasmin in real-world settings is consistent with that seen in RCTs. Most reported safety events were reversible.

This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.

 

Table 1: Effectiveness outcomes, overall and by MH status

Table 1: Effectiveness outcomes, overall and by MH status

 

Table 2: Safety outcomes

Table 2: Safety outcomes

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