Real-life experience after intravitreal ocriplasmin for vitreomacular traction and macular hole: a spectral-domain optical coherence tomography prospective study

Chatziralli, Irini; Theodossiadis, George; Parikakis, Efstratios; Datseris, Ioannis; Theodossiadis, Panagiotis

doi:10.1007/s00417-015-3031-1

Cited by 37 publications

(30 citation statements)

References 32 publications

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“…1,36 Ocriplasmin is a recombinant truncated form of human plasmin that has proteolytic activity against fibronectin, laminin and collagen, which are present at the vitreoretinal interface and help anchor the vitreous cortex to the retina. 39 Ocriplasmin was approved by the US Food and Drug Administration (FDA) in 2012 after safety and efficacy were established in two phase III clinical trials (MIVI-TRUST 006/007, NCT00781859 and NCT00798317, respectively) involving 652 patients with symptomatic VMA.…”

Section: Ocriplasmin Overview and Review Of Recent Publicationsmentioning

confidence: 99%

“…Three of 18 studies reported VA improvement in a subset of patients; two studies showed VA improvement in patients who achieved VMA/ VMT release, 1,60 and one study showed patient VA improvement following FTMH closure, but not for patients without FTMH closure. 15 cases with analysable VA data.…”

Section: Ocriplasmin Overview and Review Of Recent Publicationsmentioning

confidence: 99%

“…1,2 As the eye ages, a series of physiological events occurs to the vitreous, including liquefaction, which predisposes the eye to posterior vitreous detachment (PVD). 2 PVD is a common occurrence in ageing eyes, developing in 75 % of people over the age of 65.…”

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confidence: 99%

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Ocriplasmin Efficacy – An Analysis of Real-World Results From 2013 to 2015

Kuppermann¹

2015

European Ophthalmic Review

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As the eye ages, physiological events predispose it to posterior vitreous detachment. This normal ageing process can be complicated by persistent vitreomacular adhesion, which may develop into vitreomacular traction (VMT) accompanied by visual symptoms if forces are great enough to cause macular anatomical changes. Ocriplasmin represents a pharmacological treatment option for VMT resolution.The results of studies and cases reporting ocriplasmin treatment subsequent to US Food and Drug Administration (FDA) approval are presented. Analysis of 26 studies showed that 23 (88 %) reported VMT resolution efficacy results above 40 %, well higher than the 26.5 % efficacy reported in the two pivotal clinical trials. Subsequent analysis revealed patient baseline characteristics predicted to have higher VMT resolution. These clinical trial results were confirmed in 14 post-approval studies with subgroup analysis, consistently showing that patients with specific criteria had higher resolution than their non-criteria-matching counterparts. Visual acuity (VA) group averages were reported by 13 of 18 studies, with 12 (92 %) reporting VA improvement. Case reports of patients receiving ocriplasmin showed 10 of 15 (67 %) with VA improvement; the five cases reporting visual decline reported relatively short follow-up periods. A full understanding of ocriplasmin efficacy in clinical settings will help further identify ideal candidates for ocriplasmin treatment. An important advance in the understanding and treatment of VMT and FTMH was the development of optical coherence tomography (OCT) technology. OCT provides the basis for greater visualisation of vitreomacular anatomy and has allowed for standardisation in the definitions of VMA, This in turn has provided a more accurate understanding of both retinal anatomy and the pathophysiological processes of VMT and FTMH. 2 The importance of this technology is underscored by the fact that focal VMA can be first discovered on routine examination using OCT. 5,6,8,16 This provides an opportunity to appropriately manage these cases and follow them properly, and to make a decision on when and how to intervene. Use of OCT and standardisation of definitions and treatment algorithms will aid in the development and timing of appropriate treatments.

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Section: Ocriplasmin Overview and Review Of Recent Publicationsmentioning

confidence: 99%

Section: Ocriplasmin Overview and Review Of Recent Publicationsmentioning

confidence: 99%

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Ocriplasmin Efficacy – An Analysis of Real-World Results From 2013 to 2015

Kuppermann¹

2015

European Ophthalmic Review

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“…Interestingly, following the MIVI-TRUST trials, several authors described some small series (10-58 eyes) from the real clinical setting with higher resolution rates after ocriplasmin injection, ranging from 30 to 71% [7,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28,29]. Still, real-life experience data is limited and usually from single-center retrospective studies.…”

Section: Introductionmentioning

confidence: 99%

The Portuguese Experience with Ocriplasmin in Clinical Practice

Figueira

Martins²,

Pessoa³

et al. 2016

Ophthalmic Res

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Aim: Evaluate the real-life experience with ocriplasmin on vitreomacular traction (VMT) release and full-thickness macular hole (FTMH) closure in Portugal. Methods: Multicentric, retrospective study of 83 eyes of 78 patients who were treated with intravitreal ocriplasmin for VMT with and without FTMH. Primary outcomes were VMT release and FTMH closure. Secondary outcomes included visual acuity changes and structural features on spectral-domain ocular coherence tomography. Results: VMT resolved in 47 of the 83 eyes (56.6%) and 6 of the 12 FTMH were closed (50.0%). Mean best-corrected visual acuity (BCVA) improved from 65.1 at baseline to 70.8 ETDRS letters at the end of follow-up (p < 0.0001) with a mean follow-up of 138.8 days. Improvement in BCVA was significantly better in eyes with VMT release (p = 0.021). Approximately 73% of patients had normal ellipsoid zone integrity at the end of follow-up, 87% had no neurosensorial detachment and 40% had no intra- or subretinal fluid. Conclusion: VMT release and FTMH closure were achieved in more than half of the treated eyes and were correlated with significant BCVA improvements and favorable baseline characteristics. In fact, if a careful patient selection is carried out, VMT resolution with ocriplasmin can be optimized, tailoring the best approach to each patient.

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“…It is crucial to define the best candidates with a more favourable response to ocriplasmin: traction with a focal vitreomacular adhesion (<1500 μm), the absence of any epiretinal membrane (ERM), in cases of macular holes showing traction limited to a smaller area (≤250 μm), the presence of subretinal fluid, and younger age [6,7]. Incidentally, most of these factors also seem to increase the spontaneous resolution rate [5,6,8]. 2.…”

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confidence: 99%

Knowledge of vitreomacular traction (VMT) scenarios: Is doing nothing still a beneficial alternative and, if so, when?

Ziemssen

Bartz‐Schmidt

Dimopoulos

2016

Graefes Arch Clin Exp Ophthalmol

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It is to the great merit of the International Vitreomacular Traction (VMT) Study Group that the new classification brought clarity by reflecting the standards of modern ocular coherence (OCT) imaging [1]. These activities go back to the pioneers of pharmacologic vitreolysis [2]. The dream of replacing sophisticated intraocular surgery with a single administration of a vitreolytic agent is intriguing. The illusion of a simple injection as the solution to most cases might have slightly blurred the borders, when the medical art of doing nothing still might be the best choice anyway. A more realistic assessment started after the sobering news of transient or even permanent toxicity related to ocriplasmin [3].It is thanks to Peter Stalmans that the body of evidence regarding the natural history of VMT has increased further [4]. The retrospective study was funded, but not influenced by ThromboGenics. The excellent flowchart provided in the study (Figure 4: outcomes by baseline disease) displays how the different subgroups developed during the short follow-up period of 11 months:-Patients with vitreomacular adhesion (VMA) showed a similar rate of progression and resolution. However, the large majority (95.2 %) did not receive any treatment, though the amount of (on request) reported metarmophopsia was found to be around one in five (18 %). -In patients with vitreomacular traction (VMT) the chance of spontaneous resolution (22.7 %) and the risk of undergoing vitrectomy (25.6 %) appeared to be balanced [4]. In particular regarding the latter group, bias cannot be ruled out, as the cohort of a tertiary centre might not be representative in terms of comorbidities. Moreover, the decision might strongly depend also on the more or less aggressive approach and information policy of the individual surgeon. -The number of cases with macular holes and concomitant VMT was quite small (9.5 %). The rate of surgery did not differ from other cases with macular holes (88.7 % vs. 86.4 %). It is a limitation of the study that the author did not apply the differentiation of his own classification (small vs. large holes) and the individual peculiarity that silicone oil was used during every surgery. Therefore, we do not wish to comment on the decision regarding vitrectomy for macular holes, which might be recommended often, -at least in our experience, except in cases with a poor prognosis due to the long duration (not so seldom) and/or any end-stage atrophy.This study is of importance, as the MIVI trials did not provide comprehensive knowledge of natural disease history in the absence of a real Bplacebo^group [2]. In addition, the follow-up of the RCTs was quite short considering the situation that the story, including partial resolution, is not over after 4 weeks or 6 months, and the rate of spontaneous VMT resolution has been found to continuously rise over time [5].

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Real-life experience after intravitreal ocriplasmin for vitreomacular traction and macular hole: a spectral-domain optical coherence tomography prospective study

Cited by 37 publications

References 32 publications

Ocriplasmin Efficacy – An Analysis of Real-World Results From 2013 to 2015

Ocriplasmin Efficacy – An Analysis of Real-World Results From 2013 to 2015

The Portuguese Experience with Ocriplasmin in Clinical Practice

Knowledge of vitreomacular traction (VMT) scenarios: Is doing nothing still a beneficial alternative and, if so, when?

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