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      Intravitreal ocriplasmin for the treatment of vitreomacular traction and macular hole- A study of efficacy and safety based on NICE guidance

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          Abstract

          Purpose

          To evaluate the real world clinical outcomes of intravitreal ocriplasmin in patients with vitreomacular traction (VMT) with and without full thickness macular holes (FTMH) treated according to NICE guidance.

          Methods

          Retrospective observational case series of 25 patients treated with a single intravitreal ocriplasmin injection between December 2013 and December 2015. Best corrected visual acuity and optical coherence tomography exams were performed to determine visual outcomes and anatomical VMT release and FTMH closure over time. Two patient groups were identified: ocular macular co-morbidity (OCM) and no OCM (nOCM), with follow-up at 4, 12, and 24 weeks.

          Results

          Twenty-five patients were identified that included 19 patients with VMT, and 6 patients with VMT plus FTMH. In the nOCM group of 22 patients, the release rate of VMT was 44%, 63%, and 69% at 4, 12 and 24 weeks respectively. In the “real-world” OCM group of 25 patients, the VMT release rate was 37%, 53%, and 58% at the same time-points. In both groups, the FTMH closure rate was 33%, 50%, and 67% at 4, 12, and 24 weeks. At mean follow-up of 30 weeks in the VMT group with nOCM, the mean LogMAR VA improved significantly from 0.44 to 0.28 (p = 0.0068, paired t-test). Three were no serious adverse events.

          Conclusions

          This study reports improved efficacy of intravitreal ocriplasmin for both VMT and FTMH, and is more favourable in patients with no ocular co-morbidity. We highlight the importance of careful patient selection and structured standard of care pathways to identify patients who will benefit from the positive visual and anatomical effects of intravitreal ocriplasmin.

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          Most cited references15

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          The International Vitreomacular Traction Study Group classification of vitreomacular adhesion, traction, and macular hole.

          The International Vitreomacular Traction Study (IVTS) Group was convened to develop an optical coherence tomography (OCT)-based anatomic classification system for diseases of the vitreomacular interface (VMI).
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            Ageing changes in the eye.

            Ageing changes occur in all the structures of the eye causing varied effects. This article attempts to review the parameters of what is considered within the "normal limits" of ageing so as to be able to distinguish those conditions from true disease processes. Improving understanding of the ageing changes will help understand some of the problems that the ageing population faces.
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              Efficacy of intravitreal ocriplasmin for treatment of vitreomacular adhesion: subgroup analyses from two randomized trials.

              To evaluate the efficacy of a single intravitreal injection of ocriplasmin 125 μg across relevant subpopulations of patients with symptomatic vitreomacular adhesion (VMA)/vitreomacular traction (VMT), including when associated with macular hole.
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                Author and article information

                Contributors
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: Project administrationRole: ResourcesRole: SupervisionRole: ValidationRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: ResourcesRole: ValidationRole: Writing – original draftRole: Writing – review & editing
                Role: Data curationRole: Formal analysisRole: InvestigationRole: MethodologyRole: ValidationRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: Formal analysisRole: MethodologyRole: Project administrationRole: ResourcesRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: Project administrationRole: ResourcesRole: SupervisionRole: ValidationRole: Writing – original draftRole: Writing – review & editing
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                16 May 2018
                2018
                : 13
                : 5
                : e0197072
                Affiliations
                [1 ] Department of Vitreoretinal Surgery, Moorfields Eye Hospital, London, United Kingdom
                [2 ] Department of Medical Retina, Moorfields Eye Hospital, London, United Kingdom
                [3 ] SJT Focus Limited, Harpenden, United Kingdom
                Massachusetts Eye & Ear Infirmary, Harvard Medical School, UNITED STATES
                Author notes

                Competing Interests: We have the following interests. This study was funded by Alcon Eyecare UK. Sally Tucker and Helen Buck are employed by SJT Focus Limited. There are no patents, products in development or marketed products to declare. This does not alter our adherence to all the PLOS ONE policies on sharing data and materials, as detailed online in the guide for authors.

                ‡ These authors also contributed equally to this work

                Author information
                http://orcid.org/0000-0003-1161-3956
                Article
                PONE-D-17-32308
                10.1371/journal.pone.0197072
                5955569
                29768451
                9cd302c8-bfb9-4fdf-b5f2-e39e98f26eee
                © 2018 Muqit et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 3 September 2017
                : 25 April 2018
                Page count
                Figures: 3, Tables: 4, Pages: 12
                Funding
                Support for the NIHR London Biomedical Research Centre is acknowledged. The manuscript has been funded by Alcon Eyecare UK. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. SJT Focus Limited provided support in the form of salaries for authors ST and HB, but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific roles of these authors are articulated in the ‘author contributions’ section.
                Categories
                Research Article
                Medicine and Health Sciences
                Surgical and Invasive Medical Procedures
                Medicine and Health Sciences
                Diagnostic Medicine
                Diagnostic Radiology
                Tomography
                Research and Analysis Methods
                Imaging Techniques
                Diagnostic Radiology
                Tomography
                Medicine and Health Sciences
                Radiology and Imaging
                Diagnostic Radiology
                Tomography
                Biology and Life Sciences
                Neuroscience
                Sensory Perception
                Vision
                Visual Acuity
                Biology and Life Sciences
                Psychology
                Sensory Perception
                Vision
                Visual Acuity
                Social Sciences
                Psychology
                Sensory Perception
                Vision
                Visual Acuity
                Medicine and Health Sciences
                Surgical and Invasive Medical Procedures
                Ophthalmic Procedures
                Vitrectomy
                Medicine and Health Sciences
                Surgical and Invasive Medical Procedures
                Ophthalmic Procedures
                Cataract Surgery
                Biology and Life Sciences
                Anatomy
                Ocular System
                Ocular Anatomy
                Medicine and Health Sciences
                Anatomy
                Ocular System
                Ocular Anatomy
                Research and Analysis Methods
                Research Design
                Clinical Research Design
                Adverse Events
                Biology and Life Sciences
                Anatomy
                Ocular System
                Ocular Anatomy
                Retina
                Medicine and Health Sciences
                Anatomy
                Ocular System
                Ocular Anatomy
                Retina
                Custom metadata
                All relevant data are within the paper and its Supporting Information files.

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