46 research outputs found

    Prognostic Factors Associated with Ocriplasmin Efficacy for the Treatment of Symptomatic Vitreomacular Adhesion and Full-thickness Macular Hole: Analysis from Four Studies

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    Purpose: To assess the effect of patient baseline characteristics on the efficacy of ocriplasmin treatment for symptomatic vitreomacular adhesion (VMA) with full-thickness macular hole (FTMH) from phase 3/4 studies. Methods: Patients with symptomatic VMA and FTMH at baseline and receiving ocriplasmin treatment 12

    Safety and Efficacy of Ixoberogene Soroparvovec in Neovascular Age-Related Macular Degeneration in the United States (OPTIC): A Prospective, Two-Year, Multicentre Phase 1 Study

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    Background Gene therapy, successfully used in rare, monogenetic disorders, may prove to be a durable management approach for common, polygenetic conditions, including neovascular age-related macular degeneration (nAMD). Repeated injections, oftentimes monthly, and possibly for decades, of vascular endothelial growth factor antagonists (anti-VEGF), is the standard for nAMD. We hypothesised that an in-office, intravitreal administration of ixoberogene soroparvovec (ixo-vec, formerly ADVM-022), a single-dose gene therapy encoding for the proven anti-VEGF protein, aflibercept, would transform retinal cells to continually produce aflibercept to minimise treatment burden in nAMD. Methods In this two-year, open-label, prospective, multicentre phase 1 study, patients with nAMD responding to antiVEGF were assigned to four cohorts differing by ixo-vec dose (2 × 1011 vs 6 × 1011 vector genomes (vg/eye)) and prophylactic steroids (oral prednisone vs topical difluprednate). The primary outcome was the type, severity, and incidence of ocular and systemic adverse events (AEs); secondary endpoints included vision, central subfield thickness (CST), and the number of supplemental injections. This study was registered with ClinicalTrials.gov, NCT03748784. Findings Thirty patients with nAMD were enrolled between November 14, 2018 and June 30, 2020 at nine study sites in the United States. No systemic ixo-vec related AEs were noted. Across both dose groups the most common adverse event was anterior chamber cell, which was reported in 11 participants in the 6 × 1011 dose group and in 7 participants in the 2 × 1011 dose group; intraocular inflammation was responsive to topical corticosteroids, with no anterior chamber cells or vitreous cells observed in 2 × 1011 vg/eye patients at the end of the study. Vision and CST remained stable throughout two years with annualised anti-VEGF injections reduced by 80% (10.0 mean annualised anti-VEGF injections to 1.9) in 2 × 1011 vg/eye and 98% (9.8 mean annualised anti-VEGF injections to 0.2) in 6 × 1011 vg/eye cohorts. Interpretation Ixo-vec was generally well-tolerated, maintained vision, and improved anatomical outcomes in nAMD, with a substantial reduction in anti-VEGF injections. A single administration of an in-office gene therapy, with vectorised protein with an already established clinical benefit, has the potential to revolutionise the management of common ocular disorders requiring ongoing, frequent therapeutic interventions

    Retinal Detachment due to CrossFit Training Injury

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    The purpose of this paper is to describe a traumatic retinal detachment occurring as a result of CrossFit training using an elastic exercise band. The patient sustained an ocular injury from an elastic band during CrossFit training, resulting in a giant retinal dialysis and retinal detachment, which were successfully repaired. Trainers and athletes need to be aware of the potential for ocular injury from elastic exercise bands and take appropriate precautions

    Vitrectomy Specimen Culture Technique

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    Ocular Trauma from the “Knockout Game”

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    The “knockout game” is a new form of urban violence receiving much attention in local and national media. Apart from the obvious head trauma, eye injuries may be subtle and overlooked. This report brings awareness of potential eye damage with this type of assault. This report is of a young woman, victim of the knockout game, who sustained a submacular hemorrhage. Beyond a neurologic evaluation for anyone knocked unconscious following the knockout game, patients should be counseled regarding potential ocular injury and encouraged to seek eye care promptly should symptoms develop

    Controlled Aspiration of Subfoveal Perfluorocarbon Liquid Using a Novel Microcannula

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    Diabetes and the Eye

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    Blunt Ocular Trauma

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    A New Culture Method for Infectious Endophthalmitis

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